<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/NCT03779893</url>
  </required_header>
  <id_info>
    <org_study_id>14011989</org_study_id>
    <nct_id>NCT03779893</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Bioactive Resin Sealants vs Conventional Sealants in Permanent Molars</brief_title>
  <official_title>Clinical Evaluation of Bioactive Resin Based Pits &amp; Fissures Sealants Versus Conventional Resin Based Pits &amp; Fissures Sealants in Caries Susceptible Fissures in Permanent Molars: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be conducted to evaluate the performance; in terms of retention and caries&#xD;
      inhibition; of the newly introduced bioactive resin based pits and fissure sealant versus&#xD;
      conventional resin based pits and fissure sealant in caries susceptible fissures in posterior&#xD;
      molars in patients at risk of caries. Evaluation will be done by visual tactile examination &amp;&#xD;
      VistaCAM.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the investigator's study the comparator material will be BioCoat® by Premier® ; new&#xD;
      bioactive resin pits and fissures sealant featuring SmartCap™ Technology. SmartCap™&#xD;
      Technology utilizes patented semi-permeable resin microcapsules. In BioCoat, the rechargeable&#xD;
      SmartCap microcapsules are filled with ionic solutions of fluoride, calcium and phosphate,&#xD;
      which diffuse in and out of the sealant. Greater fluoride uptake in the presence of calcium&#xD;
      and phosphate ions is assumed.&#xD;
&#xD;
      With limited evidence based information in literature about using bioactive fissure sealants&#xD;
      in susceptible fissures , it was found beneficial to evaluate the newly introduced material&#xD;
      using a randomized controlled trial to test the null hypothesis that bioactive resin pits and&#xD;
      fissure sealant will have the same clinical performance as conventional resin based pits and&#xD;
      fissure sealant in susceptible fissures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">March 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Retention of sealant</measure>
    <time_frame>one year</time_frame>
    <description>rate of sealant loss</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Caries incidence</measure>
    <time_frame>one year</time_frame>
    <description>rate of caries initiation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">38</enrollment>
  <condition>Caries, Dental</condition>
  <arm_group>
    <arm_group_label>conventional group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional resin based Pits &amp; fissures sealant 3M™ Clinpro™ Sealant is administrated</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bioactive group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bioactive Pits &amp; fissures sealant BioCoat® by Premier®.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>BioCoat® by Premier®.</intervention_name>
    <description>Bioactive pits and fissure sealant</description>
    <arm_group_label>bioactive group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>3M™ Clinpro™ Sealant.</intervention_name>
    <description>conventional pits and fissure sealant</description>
    <arm_group_label>conventional group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria of participants:&#xD;
&#xD;
          -  Patients with bilateral caries susceptible fissures in molars showing no signs of&#xD;
             caries.&#xD;
&#xD;
          -  19 - 40 years.&#xD;
&#xD;
          -  Males or Females.&#xD;
&#xD;
          -  Co-operative patients approving to participate in the trial.&#xD;
&#xD;
        Exclusion criteria of participants:&#xD;
&#xD;
          -  Patients younger than 19 years old or older than 40 years old.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Disabilities.&#xD;
&#xD;
          -  Systemic disease or severe medical complications.&#xD;
&#xD;
          -  Allergic history concerning methacrylate.&#xD;
&#xD;
          -  Rampant caries.&#xD;
&#xD;
          -  Heavy smoking.&#xD;
&#xD;
          -  Xerostomia.&#xD;
&#xD;
          -  Lack of compliance.&#xD;
&#xD;
          -  Evidence of severe bruxism, clenching, or tempromandibular joint disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>January 12, 2019</last_update_submitted>
  <last_update_submitted_qc>January 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Alaa Fathi Abdelsalam</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03779893
org study id: 14011989
nct id: NCT03779893
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will be conducted to evaluate the performance; in terms of retention and caries
      inhibition; of the newly introduced bioactive resin based pits and fissure sealant versus
      conventional resin based pits and fissure sealant in caries susceptible fissures in posterior
      molars in patients at risk of caries. Evaluation will be done by visual tactile examination &
      VistaCAM.
In the investigator's study the comparator material will be BioCoat® by Premier® ; new
      bioactive resin pits and fissures sealant featuring SmartCap™ Technology. SmartCap™
      Technology utilizes patented semi-permeable resin microcapsules. In BioCoat, the rechargeable
      SmartCap microcapsules are filled with ionic solutions of fluoride, calcium and phosphate,
      which diffuse in and out of the sealant. Greater fluoride uptake in the presence of calcium
      and phosphate ions is assumed.

      With limited evidence based information in literature about using bioactive fissure sealants
      in susceptible fissures , it was found beneficial to evaluate the newly introduced material
      using a randomized controlled trial to test the null hypothesis that bioactive resin pits and
      fissure sealant will have the same clinical performance as conventional resin based pits and
      fissure sealant in susceptible fissures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Retention of sealant
time frame: one year
description: rate of sealant loss
measure: Caries incidence
time frame: one year
description: rate of caries initiation
arm group label: conventional group
arm group type: Active Comparator
description: Conventional resin based Pits & fissures sealant 3M™ Clinpro™ Sealant is administrated
arm group label: bioactive group
arm group type: Experimental
description: Bioactive Pits & fissures sealant BioCoat® by Premier®.
intervention type: Combination Product
intervention name: BioCoat® by Premier®.
description: Bioactive pits and fissure sealant
arm group label: bioactive group
intervention type: Combination Product
intervention name: 3M™ Clinpro™ Sealant.
description: conventional pits and fissure sealant
arm group label: conventional group
criteria: 
gender: All
minimum age: 19 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Alaa Fathi Abdelsalam
investigator title: principle investigator
mesh term: Dental Caries
sharing ipd: No