<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02995369</url>
  </required_header>
  <id_info>
    <org_study_id>2016-7229</org_study_id>
    <nct_id>NCT02995369</nct_id>
  </id_info>
  <brief_title>DryShield vs Cotton Roll Isolation During Sealants Placement: Efficiency and Patient Preference</brief_title>
  <official_title>DryShield vs Cotton Roll Isolation During Sealants Placement: Efficiency and Patient</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montefiore Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goals of this study are to determine if 1) placement times of pit and fissure sealants&#xD;
      using the DryShield system differ from those when using the cotton roll isolation technique;&#xD;
      and 2) there is a significant difference in patient preference between Dryshield and the&#xD;
      cotton roll technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pit and fissure caries account for 80 to 90 percent of all caries in permanent posterior&#xD;
      teeth. Pit-and-fissure sealants can be used effectively to prevent caries. By&#xD;
      micromechanically bonding to the teeth, they provide a physical barrier that keeps&#xD;
      microorganisms and food particles from collecting in susceptible pits and fissures, thus&#xD;
      preventing caries initiation and arresting caries progression. The effectiveness of sealants&#xD;
      for caries prevention depends on long-term retention, which is largely a function of&#xD;
      meticulousness of application: keeping the tooth surface free from saliva contamination&#xD;
      during application and polymerization is critical. Low retention of sealants has been&#xD;
      attributed to insufficient moisture control. Therefore, proper isolation of the teeth is one&#xD;
      of the most important steps when placing sealants to ensure their retention. Cotton roll&#xD;
      isolation (CRI) has been widely used for sealant placement, and is the most common method&#xD;
      among pediatric dentists. Although very effective, CRI can be a challenging technique&#xD;
      especially when used in young children: the cotton rolls can be cumbersome for both the&#xD;
      patient and the clinician. A previous study demonstrated that new moisture control systems&#xD;
      such as Isolite, produce sealant retention rates comparable to cotton roll isolation, while&#xD;
      decreasing procedure time. DryShield (DS) has recently been introduced as an all-in-one&#xD;
      isolation system. It is similar to the Isolite as it combines the tasks of fluid evacuation,&#xD;
      tongue and cheek retraction, and serves as a bite block, but differs in that it's&#xD;
      autoclavable and does not provide illumination. Its design allows it to suction and isolate&#xD;
      half the oral cavity at a time. Therefore, it should presumably facilitate sealants placement&#xD;
      under a more controlled environment, while reducing chair time for the dentist.&#xD;
&#xD;
      The goals of this study are to determine if 1) placement times of pit and fissure sealants&#xD;
      using the DryShield system differ from those when using the cotton roll isolation technique;&#xD;
      and 2) there is a significant difference in patient preference between DryShield and the&#xD;
      cotton roll technique.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2017</start_date>
  <completion_date type="Actual">March 23, 2017</completion_date>
  <primary_completion_date type="Actual">March 23, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Placement Time of Sealants Using Dryshield (DS) vs Cotton Rolls (CRI)</measure>
    <time_frame>Initial insertion of isolation aid (CRI or DS) and removal of corresponding isolation aid (CRI or DS)</time_frame>
    <description>The time for sealant application was recorded with a stopwatch by the dental assistant as follows for the techniques: the insertion of the first isolation aid (CRI or DS) in the oral cavity constituted the start time, and the end time was when the corresponding isolation aid (CRI or DS) was removed from the oral cavity after the sealants application.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Preference as Assessed by Verbal Self-report Survey</measure>
    <time_frame>Immediately after the dental procedure is completed, up to 30 minutes</time_frame>
    <description>Right after the procedure, participants completed a verbal survey. The survey consisted of seven closed-ended questions intended to assess the participants' opinion on things such as comfort, noise, taste, and tissue stretching. Some survey questions require a YES or NO answer (i.e. Did you taste any of the materials used?). Other questions required the participant to select CRI or DS (i.e. Which system was the most comfortable?). The pediatric dental attending asked each patient each question, in the same sequence.&#xD;
Patient preferences were assessed with Question number 4, which specifically asked &quot; If we did the procedure again, which system would you prefer?&quot; The options were the Cotton Roll Isolation (CRI) or the Dryshield (DS) system. The reported values represents the response to Question number 4.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Time</condition>
  <condition>Patient Preference</condition>
  <arm_group>
    <arm_group_label>Cotton Roll Isolation (left), then DryShield Isolation (right)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cotton rolls (CRI) will be used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using Dryshield (DS) on the opposite side.&#xD;
The four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cotton Roll Isolation (right), then DryShield Isolation (left)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cotton rolls (CRI) will be used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using DryShield (DS) on the opposite side.&#xD;
The four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DryShield Isolation (left), then Cotton Roll Isolation (right)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DryShield (DS) will be used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.&#xD;
The four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DryShield Isolation (right), then Cotton Roll Isolation (left)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DryShield (DS) will be used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.&#xD;
The four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DryShield</intervention_name>
    <description>DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.</description>
    <arm_group_label>Cotton Roll Isolation (left), then DryShield Isolation (right)</arm_group_label>
    <arm_group_label>Cotton Roll Isolation (right), then DryShield Isolation (left)</arm_group_label>
    <arm_group_label>DryShield Isolation (left), then Cotton Roll Isolation (right)</arm_group_label>
    <arm_group_label>DryShield Isolation (right), then Cotton Roll Isolation (left)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cotton rolls</intervention_name>
    <description>Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water is used.</description>
    <arm_group_label>Cotton Roll Isolation (left), then DryShield Isolation (right)</arm_group_label>
    <arm_group_label>Cotton Roll Isolation (right), then DryShield Isolation (left)</arm_group_label>
    <arm_group_label>DryShield Isolation (left), then Cotton Roll Isolation (right)</arm_group_label>
    <arm_group_label>DryShield Isolation (right), then Cotton Roll Isolation (left)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The target population will include healthy, cognitively normal patients who present to one&#xD;
        of the Montefiore pediatric dental clinics for an intake or a recall visit who are&#xD;
        determined to benefit from sealants application, or patients who present solely for a&#xD;
        sealant application appointment, when their examination was completed at a previous date&#xD;
        (within 6 months).&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologist (ASA) Classification I or II&#xD;
&#xD;
          -  Ages 5 to 14 years&#xD;
&#xD;
          -  Cooperative behavior at present visit or recorded at the previous encounter&#xD;
             (classified as 3 or 4 on the Frankl Behavioral Rating Scale).&#xD;
&#xD;
          -  At least one erupted caries-free permanent molar in each quadrant&#xD;
&#xD;
          -  Ability able to speak and understand English or Spanish&#xD;
&#xD;
          -  There will be no exclusions based on race, gender, and ethnicity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA Classification III or higher&#xD;
&#xD;
          -  Uncooperative behavior at present visit or recorded at the previous encounter&#xD;
             (classified as 1 or 2 on the Frankl Behavioral Rating Scale).&#xD;
&#xD;
          -  Patients who require less than four sealants on permanent molars&#xD;
&#xD;
          -  Patients who do not provide assent or consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nuntiya Kakanantadilok, DMD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montefiore Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Collette J, Wilson S, Sullivan D. A study of the Isolite system during sealant placement: efficacy and patient acceptance. Pediatr Dent. 2010 Mar-Apr;32(2):146-50.</citation>
    <PMID>20483019</PMID>
  </reference>
  <reference>
    <citation>Alhareky MS, Mermelstein D, Finkelman M, Alhumaid J, Loo C. Efficiency and patient satisfaction with the Isolite system versus rubber dam for sealant placement in pediatric patients. Pediatr Dent. 2014 Sep-Oct;36(5):400-4.</citation>
    <PMID>25303507</PMID>
  </reference>
  <reference>
    <citation>Beauchamp J, Caufield PW, Crall JJ, Donly K, Feigal R, Gooch B, Ismail A, Kohn W, Siegal M, Simonsen R; American Dental Association Council on Scientific Affairs. Evidence-based clinical recommendations for the use of pit-and-fissure sealants: a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 2008 Mar;139(3):257-68. doi: 10.14219/jada.archive.2008.0155.</citation>
    <PMID>18310730</PMID>
  </reference>
  <reference>
    <citation>Lyman T, Viswanathan K, McWhorter A. Isolite vs cotton roll isolation in the placement of dental sealants. Pediatr Dent. 2013 May-Jun;35(3):E95-9.</citation>
    <PMID>23756302</PMID>
  </reference>
  <reference>
    <citation>Primosch RE, Barr ES. Sealant use and placement techniques among pediatric dentists. J Am Dent Assoc. 2001 Oct;132(10):1442-51; quiz 1461. doi: 10.14219/jada.archive.2001.0061.</citation>
    <PMID>11680361</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <results_first_submitted>January 3, 2019</results_first_submitted>
  <results_first_submitted_qc>December 29, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 20, 2023</results_first_posted>
  <last_update_submitted>December 29, 2022</last_update_submitted>
  <last_update_submitted_qc>December 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Montefiore Medical Center</investigator_affiliation>
    <investigator_full_name>Nuntiya Kakanantadilok</investigator_full_name>
    <investigator_title>Director Division of Pediatric Dentistry</investigator_title>
  </responsible_party>
  <keyword>Sealants</keyword>
  <keyword>Dryshield</keyword>
  <keyword>Cotton roll</keyword>
  <keyword>Isolation</keyword>
  <keyword>Efficiency</keyword>
  <keyword>Preference</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 17, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT02995369/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study participants were selected from pediatric patients who presented to one of the four Montefiore pediatric dental clinics for an intake or a recall visit and who were determined to benefit from sealants application, or from patients who present solely for a sealant application appointment, when their examination was done at a previous date (within 6 months).</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Cotton Roll Isolation (Left) First, Then Dryshield Isolation (Right)</title>
          <description>Group (1) Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using Dryshield (DS) on the right side.&#xD;
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.&#xD;
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.&#xD;
The four arms/groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.</description>
        </group>
        <group group_id="P2">
          <title>Cotton Roll Isolation (Right) First, Then Dryshield Isolation (Left)</title>
          <description>Group (2) Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using Dryshield (DS) on the left side.&#xD;
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.&#xD;
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.&#xD;
The four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.</description>
        </group>
        <group group_id="P3">
          <title>Dryshield Isolation (Left) First, Then Cotton Roll Isolation (Right)</title>
          <description>Group (3) Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using cotton rolls (CRI) on the right side.&#xD;
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.&#xD;
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.&#xD;
The four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.</description>
        </group>
        <group group_id="P4">
          <title>Dryshield Isolation (Right) First, Then Cotton Roll Isolation (Left)</title>
          <description>Group (4) Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using cotton rolls (CRI) on the left side.&#xD;
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.&#xD;
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.&#xD;
The four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cotton Roll Isolation (Left) First, Then Dryshield Isolation (Right)</title>
          <description>Group (1) Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using Dryshield (DS) on the right side.&#xD;
The four arms/groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.</description>
        </group>
        <group group_id="B2">
          <title>Cotton Roll Isolation (Right) First, Then Dryshield Isolation (Left)</title>
          <description>Group (2) Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using Dryshield (DS) on the left side.&#xD;
The four arms/groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.</description>
        </group>
        <group group_id="B3">
          <title>Dryshield Isolation (Left) First, Then Cotton Roll Isolation (Right)</title>
          <description>Group (3) Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using cotton rolls (CRI) on the right side.&#xD;
The four arms/groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.</description>
        </group>
        <group group_id="B4">
          <title>Dyshield Isolation (Right) First, Then Cotton Roll Isolation (Left)</title>
          <description>Group (4) Dryshield (DS) was be used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using cotton rolls (CRI) on the left side.&#xD;
The four arms/groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="8"/>
            <count group_id="B4" value="8"/>
            <count group_id="B5" value="32"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="8"/>
                    <count group_id="B4" value="8"/>
                    <count group_id="B5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.6" lower_limit="7" upper_limit="10"/>
                    <measurement group_id="B2" value="8.6" lower_limit="6" upper_limit="11"/>
                    <measurement group_id="B3" value="8.8" lower_limit="6" upper_limit="13"/>
                    <measurement group_id="B4" value="8.5" lower_limit="6" upper_limit="12"/>
                    <measurement group_id="B5" value="8.6" lower_limit="6" upper_limit="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <description>Forms used to extract study-related data from patient files did not capture gender/sex. The forms were de-identified so it was not possible to track back to the original patient records to retrieve gender/sex data.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="8"/>
                    <count group_id="B4" value="8"/>
                    <count group_id="B5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="8"/>
                    <count group_id="B4" value="8"/>
                    <count group_id="B5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Placement Time of Sealants Using Dryshield (DS) vs Cotton Rolls (CRI)</title>
        <description>The time for sealant application was recorded with a stopwatch by the dental assistant as follows for the techniques: the insertion of the first isolation aid (CRI or DS) in the oral cavity constituted the start time, and the end time was when the corresponding isolation aid (CRI or DS) was removed from the oral cavity after the sealants application.</description>
        <time_frame>Initial insertion of isolation aid (CRI or DS) and removal of corresponding isolation aid (CRI or DS)</time_frame>
        <population>Results were analyzed and reported based on the sequence the interventions were administered.</population>
        <group_list>
          <group group_id="O1">
            <title>Cotton Roll Isolation (Left)</title>
            <description>Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using Dryshield (DS) on the opposite side.&#xD;
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.&#xD;
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.</description>
          </group>
          <group group_id="O2">
            <title>Cotton Roll Isolation (Right)</title>
            <description>Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using Dryshield (DS) on the opposite side.&#xD;
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.&#xD;
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.</description>
          </group>
          <group group_id="O3">
            <title>Dryshield Isolation (Left)</title>
            <description>Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.&#xD;
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.&#xD;
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.</description>
          </group>
          <group group_id="O4">
            <title>Dryshield Isolation (Right)</title>
            <description>Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.&#xD;
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.&#xD;
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.</description>
          </group>
        </group_list>
        <measure>
          <title>Placement Time of Sealants Using Dryshield (DS) vs Cotton Rolls (CRI)</title>
          <description>The time for sealant application was recorded with a stopwatch by the dental assistant as follows for the techniques: the insertion of the first isolation aid (CRI or DS) in the oral cavity constituted the start time, and the end time was when the corresponding isolation aid (CRI or DS) was removed from the oral cavity after the sealants application.</description>
          <population>Results were analyzed and reported based on the sequence the interventions were administered.</population>
          <units>Seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="164.88" spread="28.78"/>
                    <measurement group_id="O2" value="160.50" spread="26.00"/>
                    <measurement group_id="O3" value="164.56" spread="27.72"/>
                    <measurement group_id="O4" value="167.81" spread="28.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Preference as Assessed by Verbal Self-report Survey</title>
        <description>Right after the procedure, participants completed a verbal survey. The survey consisted of seven closed-ended questions intended to assess the participants' opinion on things such as comfort, noise, taste, and tissue stretching. Some survey questions require a YES or NO answer (i.e. Did you taste any of the materials used?). Other questions required the participant to select CRI or DS (i.e. Which system was the most comfortable?). The pediatric dental attending asked each patient each question, in the same sequence.&#xD;
Patient preferences were assessed with Question number 4, which specifically asked &quot; If we did the procedure again, which system would you prefer?&quot; The options were the Cotton Roll Isolation (CRI) or the Dryshield (DS) system. The reported values represents the response to Question number 4.</description>
        <time_frame>Immediately after the dental procedure is completed, up to 30 minutes</time_frame>
        <population>All 32 participants who were enrolled into the study were queried for their preference (CRI vs DS). Only 8 participants per group analyzed (instead of 16 as in the other Primary Outcome Measure) as the survey was only administered once per participant.</population>
        <group_list>
          <group group_id="O1">
            <title>Cotton Roll Isolation (Left) First, Then Dryshield Isolation (Right)</title>
            <description>Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using Dryshield (DS) on the opposite side.&#xD;
The four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.</description>
          </group>
          <group group_id="O2">
            <title>Cotton Roll Isolation (Right) First, Then Dryshield Isolation (Left)</title>
            <description>Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using Dryshield (DS) on the opposite side.&#xD;
The four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.</description>
          </group>
          <group group_id="O3">
            <title>Dryshield Isolation (Left) First, Then Cotton Roll Isolation (Right)</title>
            <description>Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.&#xD;
The four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.</description>
          </group>
          <group group_id="O4">
            <title>Dryshield Isolation (Right) First, Then Cotton Roll Isolation (Left)</title>
            <description>Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.&#xD;
The four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second) resulting in a 1:1:1:1 randomization ratio with each patient acting as their own control.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Preference as Assessed by Verbal Self-report Survey</title>
          <description>Right after the procedure, participants completed a verbal survey. The survey consisted of seven closed-ended questions intended to assess the participants' opinion on things such as comfort, noise, taste, and tissue stretching. Some survey questions require a YES or NO answer (i.e. Did you taste any of the materials used?). Other questions required the participant to select CRI or DS (i.e. Which system was the most comfortable?). The pediatric dental attending asked each patient each question, in the same sequence.&#xD;
Patient preferences were assessed with Question number 4, which specifically asked &quot; If we did the procedure again, which system would you prefer?&quot; The options were the Cotton Roll Isolation (CRI) or the Dryshield (DS) system. The reported values represents the response to Question number 4.</description>
          <population>All 32 participants who were enrolled into the study were queried for their preference (CRI vs DS). Only 8 participants per group analyzed (instead of 16 as in the other Primary Outcome Measure) as the survey was only administered once per participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Cotton Roll Isolation (CRI)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Dryshield (DS)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During Dental sealant appointment (average about 30 minutes)</time_frame>
      <desc>Adverse events were summarized/categorized for the four Arms/Groups based on the sequence the interventions were placed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cotton Roll Isolation (Left)</title>
          <description>Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using Dryshield (DS) on the opposite side.&#xD;
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.&#xD;
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.</description>
        </group>
        <group group_id="E2">
          <title>Cotton Roll Isolation (Right)</title>
          <description>Cotton rolls (CRI) were used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using Dryshield (DS) on the opposite side.&#xD;
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water is used.&#xD;
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.</description>
        </group>
        <group group_id="E3">
          <title>Dryshield Isolation (Left)</title>
          <description>Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.&#xD;
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.&#xD;
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.</description>
        </group>
        <group group_id="E4">
          <title>Dryshield Isolation (Right)</title>
          <description>Dryshield (DS) was used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.&#xD;
Dryshield: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time&#xD;
Cotton rolls: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water was used.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Nuntiya Kakanantadilok</name_or_title>
      <organization>Montefiore Medical Center</organization>
      <phone>718-405-8057</phone>
      <email>nkakanan@montefiore.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02995369
org study id: 2016-7229
nct id: NCT02995369
lead sponsor: 
has dmc: No
The goals of this study are to determine if 1) placement times of pit and fissure sealants
      using the DryShield system differ from those when using the cotton roll isolation technique;
      and 2) there is a significant difference in patient preference between Dryshield and the
      cotton roll technique.
Pit and fissure caries account for 80 to 90 percent of all caries in permanent posterior
      teeth. Pit-and-fissure sealants can be used effectively to prevent caries. By
      micromechanically bonding to the teeth, they provide a physical barrier that keeps
      microorganisms and food particles from collecting in susceptible pits and fissures, thus
      preventing caries initiation and arresting caries progression. The effectiveness of sealants
      for caries prevention depends on long-term retention, which is largely a function of
      meticulousness of application: keeping the tooth surface free from saliva contamination
      during application and polymerization is critical. Low retention of sealants has been
      attributed to insufficient moisture control. Therefore, proper isolation of the teeth is one
      of the most important steps when placing sealants to ensure their retention. Cotton roll
      isolation (CRI) has been widely used for sealant placement, and is the most common method
      among pediatric dentists. Although very effective, CRI can be a challenging technique
      especially when used in young children: the cotton rolls can be cumbersome for both the
      patient and the clinician. A previous study demonstrated that new moisture control systems
      such as Isolite, produce sealant retention rates comparable to cotton roll isolation, while
      decreasing procedure time. DryShield (DS) has recently been introduced as an all-in-one
      isolation system. It is similar to the Isolite as it combines the tasks of fluid evacuation,
      tongue and cheek retraction, and serves as a bite block, but differs in that it's
      autoclavable and does not provide illumination. Its design allows it to suction and isolate
      half the oral cavity at a time. Therefore, it should presumably facilitate sealants placement
      under a more controlled environment, while reducing chair time for the dentist.

      The goals of this study are to determine if 1) placement times of pit and fissure sealants
      using the DryShield system differ from those when using the cotton roll isolation technique;
      and 2) there is a significant difference in patient preference between DryShield and the
      cotton roll technique.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Placement Time of Sealants Using Dryshield (DS) vs Cotton Rolls (CRI)
time frame: Initial insertion of isolation aid (CRI or DS) and removal of corresponding isolation aid (CRI or DS)
description: The time for sealant application was recorded with a stopwatch by the dental assistant as follows for the techniques: the insertion of the first isolation aid (CRI or DS) in the oral cavity constituted the start time, and the end time was when the corresponding isolation aid (CRI or DS) was removed from the oral cavity after the sealants application.
measure: Patient Preference as Assessed by Verbal Self-report Survey
time frame: Immediately after the dental procedure is completed, up to 30 minutes
description: Right after the procedure, participants completed a verbal survey. The survey consisted of seven closed-ended questions intended to assess the participants' opinion on things such as comfort, noise, taste, and tissue stretching. Some survey questions require a YES or NO answer (i.e. Did you taste any of the materials used?). Other questions required the participant to select CRI or DS (i.e. Which system was the most comfortable?). The pediatric dental attending asked each patient each question, in the same sequence.
Patient preferences were assessed with Question number 4, which specifically asked " If we did the procedure again, which system would you prefer?" The options were the Cotton Roll Isolation (CRI) or the Dryshield (DS) system. The reported values represents the response to Question number 4.
arm group label: Cotton Roll Isolation (left), then DryShield Isolation (right)
arm group type: Experimental
description: Cotton rolls (CRI) will be used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using Dryshield (DS) on the opposite side.
The four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second).
arm group label: Cotton Roll Isolation (right), then DryShield Isolation (left)
arm group type: Experimental
description: Cotton rolls (CRI) will be used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using DryShield (DS) on the opposite side.
The four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second).
arm group label: DryShield Isolation (left), then Cotton Roll Isolation (right)
arm group type: Experimental
description: DryShield (DS) will be used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.
The four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second).
arm group label: DryShield Isolation (right), then Cotton Roll Isolation (left)
arm group type: Experimental
description: DryShield (DS) will be used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side.
The four groups are a result of randomizing the side receiving one of the interventions (CRI v. DS) as well as the order of application (first v. second).
intervention type: Device
intervention name: DryShield
description: DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.
arm group label: Cotton Roll Isolation (left), then DryShield Isolation (right)
arm group label: Cotton Roll Isolation (right), then DryShield Isolation (left)
arm group label: DryShield Isolation (left), then Cotton Roll Isolation (right)
arm group label: DryShield Isolation (right), then Cotton Roll Isolation (left)
intervention type: Other
intervention name: Cotton rolls
description: Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water is used.
arm group label: Cotton Roll Isolation (left), then DryShield Isolation (right)
arm group label: Cotton Roll Isolation (right), then DryShield Isolation (left)
arm group label: DryShield Isolation (left), then Cotton Roll Isolation (right)
arm group label: DryShield Isolation (right), then Cotton Roll Isolation (left)
criteria: 
gender: All
minimum age: 5 Years
maximum age: 14 Years
healthy volunteers: No
last name: Nuntiya Kakanantadilok, DMD
role: Principal Investigator
affiliation: Montefiore Medical Center
facility: 
country: United States
citation: Collette J, Wilson S, Sullivan D. A study of the Isolite system during sealant placement: efficacy and patient acceptance. Pediatr Dent. 2010 Mar-Apr;32(2):146-50.
PMID: 20483019
citation: Alhareky MS, Mermelstein D, Finkelman M, Alhumaid J, Loo C. Efficiency and patient satisfaction with the Isolite system versus rubber dam for sealant placement in pediatric patients. Pediatr Dent. 2014 Sep-Oct;36(5):400-4.
PMID: 25303507
citation: Beauchamp J, Caufield PW, Crall JJ, Donly K, Feigal R, Gooch B, Ismail A, Kohn W, Siegal M, Simonsen R; American Dental Association Council on Scientific Affairs. Evidence-based clinical recommendations for the use of pit-and-fissure sealants: a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 2008 Mar;139(3):257-68. doi: 10.14219/jada.archive.2008.0155.
PMID: 18310730
citation: Lyman T, Viswanathan K, McWhorter A. Isolite vs cotton roll isolation in the placement of dental sealants. Pediatr Dent. 2013 May-Jun;35(3):E95-9.
PMID: 23756302
citation: Primosch RE, Barr ES. Sealant use and placement techniques among pediatric dentists. J Am Dent Assoc. 2001 Oct;132(10):1442-51; quiz 1461. doi: 10.14219/jada.archive.2001.0061.
PMID: 11680361
responsible party type: Principal Investigator
investigator affiliation: Montefiore Medical Center
investigator full name: Nuntiya Kakanantadilok
investigator title: Director Division of Pediatric Dentistry
sharing ipd: No
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