xml: <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/NCT05969756</url>
    </required_header>
    <id_info>
      <org_study_id>H2023/012</org_study_id>
      <nct_id>NCT05969756</nct_id>
    </id_info>
    <brief_title>Early Treatments for Preventing Occlusal Caries Lesions</brief_title>
    <official_title>Clinical Effectiveness of Early Treatments for Preventing Occlusal Caries Lesions in Erupting Permanent Molars</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hue University of Medicine and Pharmacy</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hue University of Medicine and Pharmacy</source>
    <oversight_info>
      <has_dmc>No</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>
        Sealants effectively arrest non-cavitated caries lesions on the fully erupted occlusal&#xD;
        surface of permanent teeth. However, the clinical effectiveness of sealants is uncertain in&#xD;
        preventing occlusal caries lesions in partially erupted permanent molars. This study aims to&#xD;
        evaluate the progression of caries, the degree of retention, survival rate, and quality of&#xD;
        the remnant after applying conventional total-etch resinous sealant and self-etch sealant in&#xD;
        erupting molars.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 31, 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>This is a 3 arm clinical trial. All selected permanent molars will be randomly equally allocated into three groups according to material used.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>Blinding of examiners is impossible to be done during intervention and follow up due to different natures of the materials. However, participants and outcome assessors could be blinded (double blinding).</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Development of new caries lesion</measure>
      <time_frame>3 months</time_frame>
      <description>ICDAS was considered &quot;0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Development of new caries lesion</measure>
      <time_frame>6 months</time_frame>
      <description>ICDAS was considered &quot;0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Development of new caries lesion</measure>
      <time_frame>9 months</time_frame>
      <description>ICDAS was considered &quot;0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Development of new caries lesion</measure>
      <time_frame>12 months</time_frame>
      <description>ICDAS was considered &quot;0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sealants retention</measure>
      <time_frame>3 months</time_frame>
      <description>Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sealants retention</measure>
      <time_frame>6 months</time_frame>
      <description>Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sealants retention</measure>
      <time_frame>9 months</time_frame>
      <description>Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sealants retention</measure>
      <time_frame>12 months</time_frame>
      <description>Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of sealants</measure>
      <time_frame>3 months</time_frame>
      <description>Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of sealants</measure>
      <time_frame>6 months</time_frame>
      <description>Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of sealants</measure>
      <time_frame>9 months</time_frame>
      <description>Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of sealants</measure>
      <time_frame>12 months</time_frame>
      <description>Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">114</enrollment>
    <condition>Caries; Initial</condition>
    <condition>Occlusal Caries</condition>
    <condition>Caries,Dental</condition>
    <arm_group>
      <arm_group_label>Fluoride varnish group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>5% sodium fluoride varnish, 3M, USA</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conventional etch and rinse sealant group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Resin-based composite sealant, 3M, USA</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Self-etch sealant group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Self-etch primed sealant, Shofu, Japan</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Fluoride varnish</intervention_name>
      <description>Thirty-eight permanent molars will receive 5% sodium fluoride varnish application every three months</description>
      <arm_group_label>Fluoride varnish group</arm_group_label>
      <other_name>3M™ Clinpro™ White Varnish</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Conventional etch and rinse sealant</intervention_name>
      <description>Thirty-eight permanent molars will receive conventional etch and rinse sealant</description>
      <arm_group_label>Conventional etch and rinse sealant group</arm_group_label>
      <other_name>3M™ Clinpro™ Sealant</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Self-etch sealant</intervention_name>
      <description>Thirty-eight permanent molars will receive self-etch sealant</description>
      <arm_group_label>Self-etch sealant group</arm_group_label>
      <other_name>S-PRG filler-containing resin sealant</other_name>
      <other_name>Beautisealant</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          For children:&#xD;
  &#xD;
            1. Children presenting with good general health and cooperative behavior.&#xD;
  &#xD;
            2. Children having early caries lesions in a permanent molar (first or second).&#xD;
  &#xD;
            3. Parents signed informed consent.&#xD;
  &#xD;
          For permanent molars:&#xD;
  &#xD;
            1. Early caries lesions on the occlusal surface corresponding to International Caries&#xD;
               Detection and Assessment System (ICDAS) scores 1 and 2. [Ismail AI, Sohn W, Tellez M,&#xD;
               Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment&#xD;
               System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral&#xD;
               Epidemiol. 2007 Jun;35(3):170-8].&#xD;
  &#xD;
            2. Erupting molars: eruption stages 2 (fully erupted occlusal surface with less than half&#xD;
               of the crown exposed) and 3 (fully erupted occlusal surface with more than half of the&#xD;
               crown exposed). [Carvalho JC, Ekstrand KR, Thylstrup A. Dental plaque and caries on&#xD;
               occlusal surfaces of first permanent molars in relation to stage of eruption. J Dent&#xD;
               Res. 1989 May;68(5):773-9].&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          For children:&#xD;
  &#xD;
            1. Any allergy reported by the parents.&#xD;
  &#xD;
            2. Children unable to return for recall visits.&#xD;
  &#xD;
          For permanent molars:&#xD;
  &#xD;
            1. Teeth with occlusal surfaces completely covered by the gingival tissue.&#xD;
  &#xD;
            2. Teeth with hypoplastic defects, restorations, or sealants.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>14 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Van Nhat Thang Le, DDS, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hue University of Medicine and Pharmacy</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Van Nhat Thang Le, DDS, PhD</last_name>
      <phone>+84931199077</phone>
      <email>lvnthang@hueuni.edu.vn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hue University of Medicine and Pharmacy</name>
        <address>
          <city>Hue</city>
          <state>Thua Thien Hue</state>
          <zip>49120</zip>
          <country>Vietnam</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Thanh Thao Nguyen, MD, PhD</last_name>
        <email>stir@huemed-univ.edu.vn</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Phu Vang Hospital</name>
        <address>
          <city>Phu Vang</city>
          <state>Thua Thien Hue</state>
          <zip>49900</zip>
          <country>Vietnam</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Van Lich Tran, DDS</last_name>
        <email>tranvanlich85@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Vietnam</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hue University of Medicine and Pharmacy</investigator_affiliation>
      <investigator_full_name>Le Van Nhat Thang</investigator_full_name>
      <investigator_title>DDS, PhD, Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>early caries lesions</keyword>
    <keyword>sealants</keyword>
    <keyword>erupting molars</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dental Caries</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fluorides</mesh_term>
      <mesh_term>Fluorides, Topical</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Will plan to share information when finishing study</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Plan to complete study in 1 year and will share the data after get publication</ipd_time_frame>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05969756
  org study id: H2023/012
  nct id: NCT05969756
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Sealants effectively arrest non-cavitated caries lesions on the fully erupted occlusal
        surface of permanent teeth. However, the clinical effectiveness of sealants is uncertain in
        preventing occlusal caries lesions in partially erupted permanent molars. This study aims to
        evaluate the progression of caries, the degree of retention, survival rate, and quality of
        the remnant after applying conventional total-etch resinous sealant and self-etch sealant in
        erupting molars.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a 3 arm clinical trial. All selected permanent molars will be randomly equally allocated into three groups according to material used.
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: Blinding of examiners is impossible to be done during intervention and follow up due to different natures of the materials. However, participants and outcome assessors could be blinded (double blinding).
  measure: Development of new caries lesion
  time frame: 3 months
  description: ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
  measure: Development of new caries lesion
  time frame: 6 months
  description: ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
  measure: Development of new caries lesion
  time frame: 9 months
  description: ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
  measure: Development of new caries lesion
  time frame: 12 months
  description: ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
  measure: Sealants retention
  time frame: 3 months
  description: Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.
  measure: Sealants retention
  time frame: 6 months
  description: Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.
  measure: Sealants retention
  time frame: 9 months
  description: Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.
  measure: Sealants retention
  time frame: 12 months
  description: Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.
  measure: Quality of sealants
  time frame: 3 months
  description: Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.
  measure: Quality of sealants
  time frame: 6 months
  description: Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.
  measure: Quality of sealants
  time frame: 9 months
  description: Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.
  measure: Quality of sealants
  time frame: 12 months
  description: Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.
  arm group label: Fluoride varnish group
  arm group type: Experimental
  description: 5% sodium fluoride varnish, 3M, USA
  arm group label: Conventional etch and rinse sealant group
  arm group type: Experimental
  description: Resin-based composite sealant, 3M, USA
  arm group label: Self-etch sealant group
  arm group type: Active Comparator
  description: Self-etch primed sealant, Shofu, Japan
  intervention type: Drug
  intervention name: Fluoride varnish
  description: Thirty-eight permanent molars will receive 5% sodium fluoride varnish application every three months
  arm group label: Fluoride varnish group
  other name: 3M™ Clinpro™ White Varnish
  intervention type: Drug
  intervention name: Conventional etch and rinse sealant
  description: Thirty-eight permanent molars will receive conventional etch and rinse sealant
  arm group label: Conventional etch and rinse sealant group
  other name: 3M™ Clinpro™ Sealant
  intervention type: Drug
  intervention name: Self-etch sealant
  description: Thirty-eight permanent molars will receive self-etch sealant
  arm group label: Self-etch sealant group
  other name: S-PRG filler-containing resin sealant
  other name: Beautisealant
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 14 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Van Nhat Thang Le, DDS, PhD
  role: Principal Investigator
  affiliation: Hue University of Medicine and Pharmacy
  last name: Van Nhat Thang Le, DDS, PhD
  phone: +84931199077
  email: lvnthang@hueuni.edu.vn
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Vietnam
  responsible party type: Principal Investigator
  investigator affiliation: Hue University of Medicine and Pharmacy
  investigator full name: Le Van Nhat Thang
  investigator title: DDS, PhD, Principal Investigator
  mesh term: Dental Caries
  mesh term: Fluorides
  mesh term: Fluorides, Topical
  sharing ipd: Yes
  ipd description: Will plan to share information when finishing study
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Plan to complete study in 1 year and will share the data after get publication