<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/NCT04430387</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-DB-20-0381</org_study_id>
    <nct_id>NCT04430387</nct_id>
  </id_info>
  <brief_title>Dental Isolation Methods in Pediatric Patients</brief_title>
  <official_title>Evaluation of Impact on Environmental Spatter Using Different Isolation Methods During Hygiene Appointment Among Pediatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to collect, measure, and assess the environmental spatter&#xD;
      produced during dental appointments under different isolation methods used in pediatric&#xD;
      dentistry, to compare the effectiveness of aerosol reduction between these methods, to&#xD;
      identify the most effective way to manage aerosol during dental prophylaxis for pediatric&#xD;
      patients and to provide clinical evidence to facilitate practice guidelines in dentistry&#xD;
      related to COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The study initially aimed to measure droplets; however, as more was learned about COVID&#xD;
    transmission, it became apparent that aerosol should be measured, but the method to measure&#xD;
    aerosol was not possible for this study, so the study was withdrawn.&#xD;
  </why_stopped>
  <start_date type="Anticipated">November 1, 2021</start_date>
  <completion_date type="Anticipated">November 2022</completion_date>
  <primary_completion_date type="Anticipated">November 2022</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Recruited subjects will be randomly assigned to one of the three study groups for isolation during their dental cleaning, which are: Group 1- The saliva ejector; Group 2- The high-volume evacuator (HVE); Group 3- The DryShield.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The assessor will be blind to group assignment of the patients</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>To collect, measure, and assess the environmental spatter produced during dental appointments under different isolation methods used in pediatric dentistry</measure>
    <time_frame>Through case completion, an average a year</time_frame>
    <description>The image of the spots of fluorescence from the spatter collected will be captured using a digital camera (Nikon D3100, Nikon, Tokyo, Japan) with an amber-colored lens cover. The image will be processed by a digital imaging software, ImageJ (National Institutes of Health, the Laboratory for Optical and Computational Instrumentation, University of Wisconsin) to get the number of the spots on each mask and film. The number of fluorescent spots is recorded to determine the amount of spatter produced.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Dental Plaque</condition>
  <condition>Calculus, Dental</condition>
  <condition>Aerosol Disease</condition>
  <arm_group>
    <arm_group_label>Group 1- The saliva ejector</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2- The high-volume evacuator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3- The DryShield</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The saliva ejector</intervention_name>
    <description>A thin suction tube that draws water, saliva, blood, and debris from the mouth to provide patient comfort, preventing patient from constantly having to sit up and spit while maintain a clear operative field. It is connected through the low-volume suction hose in the dental chair. It can be held by the dental assistant, the dental provider or by the patient. In practice, it can be also contoured and hang by the cheek of the patient due to its light weight.</description>
    <arm_group_label>Group 1- The saliva ejector</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The high-volume evacuator</intervention_name>
    <description>The high-velocity air evacuation device. It is connected through the high-volume suction hose in the dental chair. It is operated by a dental assistant during the dental treatment, owing to the challenge posed by the rigid disposable attachment and bulky high-volume suction hose.</description>
    <arm_group_label>Group 2- The high-volume evacuator</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The DryShield</intervention_name>
    <description>The device is attached to the high-volume suction hose to provide continuous suction of intraoral fluid and debris, and also simultaneous isolation to both maxillary and mandibular quadrants on the same side. Other advantages of these devices include retracting the tongue and cheek, and prevention of aspiration.</description>
    <arm_group_label>Group 3- The DryShield</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA 1 patients&#xD;
&#xD;
          -  Receiving dental prophylaxis or restorative procedure not requiring sedation or&#xD;
             nitrous oxide&#xD;
&#xD;
          -  Ability to cooperate in the dental chair&#xD;
&#xD;
          -  Parents speak/read either English or Spanish and consent to study&#xD;
&#xD;
          -  Child, when age appropriate, can assent to study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that do not meet the above criteria (including inability to cooperate or&#xD;
             special health care need)&#xD;
&#xD;
          -  Parents that do not speak/read either English or Spanish&#xD;
&#xD;
          -  Children that do not assent (when age appropriate) to the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Di I Wu, DDS,MS,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UTHealth Science Center at Houston</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>October 21, 2021</last_update_submitted>
  <last_update_submitted_qc>October 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Di Wu, DDS MS PhD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>infection control</keyword>
  <keyword>dental hygiene</keyword>
  <keyword>spatter</keyword>
  <keyword>aerosol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Plaque</mesh_term>
    <mesh_term>Dental Calculus</mesh_term>
    <mesh_term>Calculi</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Not sharing</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04430387
org study id: HSC-DB-20-0381
nct id: NCT04430387
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study is to collect, measure, and assess the environmental spatter
      produced during dental appointments under different isolation methods used in pediatric
      dentistry, to compare the effectiveness of aerosol reduction between these methods, to
      identify the most effective way to manage aerosol during dental prophylaxis for pediatric
      patients and to provide clinical evidence to facilitate practice guidelines in dentistry
      related to COVID-19.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Recruited subjects will be randomly assigned to one of the three study groups for isolation during their dental cleaning, which are: Group 1- The saliva ejector; Group 2- The high-volume evacuator (HVE); Group 3- The DryShield.
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: The assessor will be blind to group assignment of the patients
measure: To collect, measure, and assess the environmental spatter produced during dental appointments under different isolation methods used in pediatric dentistry
time frame: Through case completion, an average a year
description: The image of the spots of fluorescence from the spatter collected will be captured using a digital camera (Nikon D3100, Nikon, Tokyo, Japan) with an amber-colored lens cover. The image will be processed by a digital imaging software, ImageJ (National Institutes of Health, the Laboratory for Optical and Computational Instrumentation, University of Wisconsin) to get the number of the spots on each mask and film. The number of fluorescent spots is recorded to determine the amount of spatter produced.
arm group label: Group 1- The saliva ejector
arm group type: Active Comparator
arm group label: Group 2- The high-volume evacuator
arm group type: Active Comparator
arm group label: Group 3- The DryShield
arm group type: Active Comparator
intervention type: Device
intervention name: The saliva ejector
description: A thin suction tube that draws water, saliva, blood, and debris from the mouth to provide patient comfort, preventing patient from constantly having to sit up and spit while maintain a clear operative field. It is connected through the low-volume suction hose in the dental chair. It can be held by the dental assistant, the dental provider or by the patient. In practice, it can be also contoured and hang by the cheek of the patient due to its light weight.
arm group label: Group 1- The saliva ejector
intervention type: Device
intervention name: The high-volume evacuator
description: The high-velocity air evacuation device. It is connected through the high-volume suction hose in the dental chair. It is operated by a dental assistant during the dental treatment, owing to the challenge posed by the rigid disposable attachment and bulky high-volume suction hose.
arm group label: Group 2- The high-volume evacuator
intervention type: Device
intervention name: The DryShield
description: The device is attached to the high-volume suction hose to provide continuous suction of intraoral fluid and debris, and also simultaneous isolation to both maxillary and mandibular quadrants on the same side. Other advantages of these devices include retracting the tongue and cheek, and prevention of aspiration.
arm group label: Group 3- The DryShield
criteria: 
gender: All
minimum age: 4 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Di I Wu, DDS,MS,PhD
role: Principal Investigator
affiliation: UTHealth Science Center at Houston
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Di Wu, DDS MS PhD
investigator title: Assistant Professor
mesh term: Dental Plaque
mesh term: Dental Calculus
mesh term: Calculi
sharing ipd: No
ipd description: Not sharing