<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/NCT02998814</url>
  </required_header>
  <id_info>
    <org_study_id>HEK 10/13-9</org_study_id>
    <nct_id>NCT02998814</nct_id>
  </id_info>
  <brief_title>Clinical Follow Up of a Fissure Sealant Placed With Different Adhesive Protocols: 2-Year Randomized Split Mouth Study</brief_title>
  <official_title>Split Mouth Clinical Trial of Fissure Sealant Retention With Self Etching and Total Etch Bonding Agent</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate the retention rates of a fissure sealant placed&#xD;
      using different adhesive protocols over 24 months.Twenty-four subjects with no restoration&#xD;
      and caries received fissure sealants (Clinpro™Sealant, 3M/ESPE) placed with different&#xD;
      adhesive protocols. A total of 292 sealants (73 for each group) were placed. The sealants&#xD;
      were placed as follows; a-without adhesive (acid-etch only), b-with an etch-and-rinse&#xD;
      adhesive (SingleBondTM), c-with a self-etch adhesive (AdperTMEasyBond), d-with&#xD;
      acid-etch+self-etch adhesive (AdperTMEasyBond) by two previously calibrated dentists using a&#xD;
      table of random numbers. Two other calibrated examiners, independently evaluated the sealants&#xD;
      at baseline and at 6-, 12-, 18-, and 24-month recalls. Each sealant was evaluated in terms of&#xD;
      caries formation being present or absent and retention using the following criteria:&#xD;
      1=completely retained, 2=partial loss, and 3=total loss. The Pearson χ2 test was used to&#xD;
      evaluate differences in retention rates among the sealants for each evaluation period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dental caries, which can be encountered by individuals throughout their lives, is one of the&#xD;
      most chronic diseases worldwide. Researches have mainly been focusing on the prevention of&#xD;
      tooth caries with the awareness of this fact. The use of fluorides as well as pit-and-fissure&#xD;
      sealants are the most common preventive applications against caries progression.Modern&#xD;
      adhesives combine conventional conditioning, priming and bonding steps (etch-and-rinse&#xD;
      adhesives) together into one or two bottle (self-etch adhesives) to ease adhesive protocols.&#xD;
      However, it is still suspicious whether modern self-etch adhesives have equal bonding&#xD;
      capacity to the conventional etch-and-rinse systems. Therefore, clinical trials are necessary&#xD;
      to evaluate long-term adhesive performance of self-etch adhesives compared to the&#xD;
      conventional etch-and-rinse ones.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in retention of sealants from baseline to two years</measure>
    <time_frame>at baseline and at 6-, 12-, 18-, and 24-month</time_frame>
    <description>The assessment of the retention of sealants (intact, partially lost, completely lost) will be carried out every 6 month for 2 years.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Fissure Sealant Loss</condition>
  <condition>Caries</condition>
  <arm_group>
    <arm_group_label>acid-etch only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Selected teeth would receive prophylaxis with pumice using prophylaxis brushes for 20 seconds. The teeth will be isolated with cotton rolls before application of bonding agent. The tooth selected for acid-etch only will be treated with 37% phosphoric acid for 15 seconds followed by rinsing for 30 seconds and then drying with air syringe till frosty white appearance is achieved. Clinpro(3M ESPE) fissure sealant will be applied to pits and fissures and then light cured for 20 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>self-etch adhesive</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Selected teeth would receive prophylaxis with pumice using prophylaxis brushes for 20 seconds. The teeth will be isolated with cotton rolls before application of bonding agent. The tooth selected for self-etch adhesive will be treated with self-etch adhesive (AdperTM EasyBond, 3M ESPE) for 10 seconds followed by light curing for 20 seconds. Clinpro(3M ESPE) fissure sealant will be applied to pits and fissures and then light cured for 20 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>etch-and-rinse adhesive</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Selected teeth would receive prophylaxis with pumice using prophylaxis brushes for 20 seconds. The teeth will be isolated with cotton rolls before application of bonding agent. The tooth selected for etch-and-rinse adhesive will be treated with 37% phosphoric acid for 15 seconds followed by rinsing for 30 seconds and then drying with air syringe till frosty white appearance is achieved. Then, etch-and-rinse adhesive (Single BondTM, 3M ESPE) will be treated with for 10 seconds followed by light curing for 20 seconds.Clinpro(3M ESPE) fissure sealant will be applied to pits and fissures and then light cured for 20 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>self-etch adhesive after acid-etch</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Selected teeth would receive prophylaxis with pumice using prophylaxis brushes for 20 seconds. The teeth will be isolated with cotton rolls before application of bonding agent. The tooth selected for acid etch + self-etch adhesive will be treated with 37% phosphoric acid for 15 seconds followed by rinsing for 30 seconds and then drying with air syringe till frosty white appearance is achieved. Then, self-etch adhesive (AdperTM EasyBond, 3M ESPE) will be treated with for 10 seconds followed by light curing for 20 seconds.Clinpro(3M ESPE) fissure sealant will be applied to pits and fissures and then light cured for 20 seconds.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>acid-etch</intervention_name>
    <description>acid-etch</description>
    <arm_group_label>acid-etch only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>self-etch adhesive</intervention_name>
    <description>Self etch (7th generation ) bonding agent</description>
    <arm_group_label>self-etch adhesive</arm_group_label>
    <other_name>Adper Easy bond 3M ESPE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>etch-and-rinse adhesive</intervention_name>
    <description>Total etch bonding agent (5th generation)</description>
    <arm_group_label>etch-and-rinse adhesive</arm_group_label>
    <other_name>Single BondTM, 3M ESPE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>self-etch adhesive after acid-etch</intervention_name>
    <description>acid etch + self-etch adhesive Self etch (7th generation ) bonding agent</description>
    <arm_group_label>self-etch adhesive after acid-etch</arm_group_label>
    <other_name>acid etch + self-etch adhesive</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who participated in the current study had good general and oral health and&#xD;
             hygiene.&#xD;
&#xD;
          -  with no detecatable caries, bruxism, malocclusion, previously placed restorations or&#xD;
             sealants on the fissures, or no allergies to resins&#xD;
&#xD;
          -  willing to return for follow-up examinations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Third molars&#xD;
&#xD;
          -  Uncooperative patients&#xD;
&#xD;
          -  Molar teeth with antagonist tooth not present or extracted&#xD;
&#xD;
          -  Mentally and physically handicapped patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>23 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>A.Ruya Yazici, DDS, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hacettepe University School of Dentistry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hacettepe University</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/25864681?dopt=Abstract</url>
    <description>pubmed</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/11145354?dopt=Abstract</url>
    <description>pubmed</description>
  </link>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>December 16, 2016</last_update_submitted>
  <last_update_submitted_qc>December 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Zeynep Bilge Kutuk</investigator_full_name>
    <investigator_title>Research assistant</investigator_title>
  </responsible_party>
  <keyword>fissure sealant</keyword>
  <keyword>etch and rinse</keyword>
  <keyword>self etch</keyword>
  <!-- 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/NCT02998814
org study id: HEK 10/13-9
nct id: NCT02998814
lead sponsor: 
has dmc: Yes
The purpose of this study was to evaluate the retention rates of a fissure sealant placed
      using different adhesive protocols over 24 months.Twenty-four subjects with no restoration
      and caries received fissure sealants (Clinpro™Sealant, 3M/ESPE) placed with different
      adhesive protocols. A total of 292 sealants (73 for each group) were placed. The sealants
      were placed as follows; a-without adhesive (acid-etch only), b-with an etch-and-rinse
      adhesive (SingleBondTM), c-with a self-etch adhesive (AdperTMEasyBond), d-with
      acid-etch+self-etch adhesive (AdperTMEasyBond) by two previously calibrated dentists using a
      table of random numbers. Two other calibrated examiners, independently evaluated the sealants
      at baseline and at 6-, 12-, 18-, and 24-month recalls. Each sealant was evaluated in terms of
      caries formation being present or absent and retention using the following criteria:
      1=completely retained, 2=partial loss, and 3=total loss. The Pearson χ2 test was used to
      evaluate differences in retention rates among the sealants for each evaluation period.
Dental caries, which can be encountered by individuals throughout their lives, is one of the
      most chronic diseases worldwide. Researches have mainly been focusing on the prevention of
      tooth caries with the awareness of this fact. The use of fluorides as well as pit-and-fissure
      sealants are the most common preventive applications against caries progression.Modern
      adhesives combine conventional conditioning, priming and bonding steps (etch-and-rinse
      adhesives) together into one or two bottle (self-etch adhesives) to ease adhesive protocols.
      However, it is still suspicious whether modern self-etch adhesives have equal bonding
      capacity to the conventional etch-and-rinse systems. Therefore, clinical trials are necessary
      to evaluate long-term adhesive performance of self-etch adhesives compared to the
      conventional etch-and-rinse ones.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Changes in retention of sealants from baseline to two years
time frame: at baseline and at 6-, 12-, 18-, and 24-month
description: The assessment of the retention of sealants (intact, partially lost, completely lost) will be carried out every 6 month for 2 years.
arm group label: acid-etch only
arm group type: Active Comparator
description: Selected teeth would receive prophylaxis with pumice using prophylaxis brushes for 20 seconds. The teeth will be isolated with cotton rolls before application of bonding agent. The tooth selected for acid-etch only will be treated with 37% phosphoric acid for 15 seconds followed by rinsing for 30 seconds and then drying with air syringe till frosty white appearance is achieved. Clinpro(3M ESPE) fissure sealant will be applied to pits and fissures and then light cured for 20 seconds.
arm group label: self-etch adhesive
arm group type: Active Comparator
description: Selected teeth would receive prophylaxis with pumice using prophylaxis brushes for 20 seconds. The teeth will be isolated with cotton rolls before application of bonding agent. The tooth selected for self-etch adhesive will be treated with self-etch adhesive (AdperTM EasyBond, 3M ESPE) for 10 seconds followed by light curing for 20 seconds. Clinpro(3M ESPE) fissure sealant will be applied to pits and fissures and then light cured for 20 seconds.
arm group label: etch-and-rinse adhesive
arm group type: Active Comparator
description: Selected teeth would receive prophylaxis with pumice using prophylaxis brushes for 20 seconds. The teeth will be isolated with cotton rolls before application of bonding agent. The tooth selected for etch-and-rinse adhesive will be treated with 37% phosphoric acid for 15 seconds followed by rinsing for 30 seconds and then drying with air syringe till frosty white appearance is achieved. Then, etch-and-rinse adhesive (Single BondTM, 3M ESPE) will be treated with for 10 seconds followed by light curing for 20 seconds.Clinpro(3M ESPE) fissure sealant will be applied to pits and fissures and then light cured for 20 seconds.
arm group label: self-etch adhesive after acid-etch
arm group type: Active Comparator
description: Selected teeth would receive prophylaxis with pumice using prophylaxis brushes for 20 seconds. The teeth will be isolated with cotton rolls before application of bonding agent. The tooth selected for acid etch + self-etch adhesive will be treated with 37% phosphoric acid for 15 seconds followed by rinsing for 30 seconds and then drying with air syringe till frosty white appearance is achieved. Then, self-etch adhesive (AdperTM EasyBond, 3M ESPE) will be treated with for 10 seconds followed by light curing for 20 seconds.Clinpro(3M ESPE) fissure sealant will be applied to pits and fissures and then light cured for 20 seconds.
intervention type: Other
intervention name: acid-etch
description: acid-etch
arm group label: acid-etch only
intervention type: Other
intervention name: self-etch adhesive
description: Self etch (7th generation ) bonding agent
arm group label: self-etch adhesive
other name: Adper Easy bond 3M ESPE
intervention type: Other
intervention name: etch-and-rinse adhesive
description: Total etch bonding agent (5th generation)
arm group label: etch-and-rinse adhesive
other name: Single BondTM, 3M ESPE
intervention type: Other
intervention name: self-etch adhesive after acid-etch
description: acid etch + self-etch adhesive Self etch (7th generation ) bonding agent
arm group label: self-etch adhesive after acid-etch
other name: acid etch + self-etch adhesive
criteria: 
gender: All
minimum age: 20 Years
maximum age: 23 Years
healthy volunteers: Accepts Healthy Volunteers
last name: A.Ruya Yazici, DDS, PhD
role: Study Director
affiliation: Hacettepe University School of Dentistry
facility: 
country: Turkey
url: https://www.ncbi.nlm.nih.gov/pubmed/25864681?dopt=Abstract
description: pubmed
url: https://www.ncbi.nlm.nih.gov/pubmed/11145354?dopt=Abstract
description: pubmed
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Zeynep Bilge Kutuk
investigator title: Research assistant