<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/NCT03827889</url>
  </required_header>
  <id_info>
    <org_study_id>UNIB5</org_study_id>
    <nct_id>NCT03827889</nct_id>
  </id_info>
  <brief_title>Efficacy of Two Protocols for Applying Fluorine Varnish to Deciduous Teeth</brief_title>
  <acronym>CEPECO3</acronym>
  <official_title>Efficacy of Two Protocols for Applying Fluorine Varnish to Initial Active Lesions of Deciduous Teeth: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Ibirapuera</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Ibirapuera</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evidence that the data flow analysis tests, there are still no studies that show the clarity&#xD;
      of the protocols of its application, including the interval and execution factors of&#xD;
      applications, concentration of fluoridation and previous prophylaxis. That is, there are&#xD;
      still large gaps regarding fluoride varnish applications. Thus, the objective of the present&#xD;
      project is the selection of two protocols for application of fluid applications in active&#xD;
      drugs in primary tooth enamel. The longitudinal follow-up will be performed in a period of 3,&#xD;
      6, 12, 18 and 24 months after the procedure. The progression of a subject will be evaluated&#xD;
      clinically through the transition of ICDAS scores and assessment of the lesions (sound&#xD;
      examination with superficial measurements) by visual examination, and the physician evaluates&#xD;
      the efficacy and the ability to evaluate the therapeutic techniques and evaluation.&#xD;
      treatment, cost and quality of life of participants&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Outbreak of COVID-19.&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 1, 2024</start_date>
  <completion_date type="Anticipated">December 30, 2027</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2025</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PROGRESSION OF CARIES LESIONS (caries lesions inactivation assessment)</measure>
    <time_frame>Every 6 months up to 24 months</time_frame>
    <description>Caries progression will be evaluated radiographically by three previously trained evaluators (through theoretical classes and evaluation of 13 clinical photographs) and calibrated. These examiners will not know the chronological order and compare the images two to two first by two evaluators and when there is disagreement between the two, the third examiner shall be called for tie-breaker. The possible progression of the treated caries lesion will be codified as:&#xD;
Present progression: Change in radiolucidity area of the Lesion&#xD;
Absent progression: No change in the area of radiolucidity of the lesion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of surfaces with NEW CARIES LESIONS</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Detection of the presence of new lesions in deciduous and permanent teeth through visual inspection after dental cleaning. New lesions will be recorded using ICDAS scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Children self-reported discomfort</measure>
    <time_frame>baseline (Immediately after procedure)</time_frame>
    <description>The child's discomfort will be assessed immediately after the sequence of treatments performed in each session by the Wong-Baker face scale. Each face corresponds to a number in a numeric scale from 0 to 5, being 0 no discomfort and 5 maximum of discomfort. At the end, the averages of each score will be compared between the experimental groups.The patient will be asked to choose the face that is more similar to how he/she felt during the treatment. The answer should be given solely by the child, which means no parental or professional interferences.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COST-EFFICACY of each protocol</measure>
    <time_frame>up to 24 months</time_frame>
    <description>To evaluate the cost-efficacy of different protocols by total value in dollar of treatment in relation to efficacy.The quantities of all consumables used in each procedure will be annotated, as well as the time spent in each procedure, money and time will be combined to report the cost of procedures, measured by $/hour. In addition, we will verify the efficacy through the need for new surgical treatments or new caries lesions. In this way, we will compare the experimental groups according to the cost ($/hour) x the efficacy (need for new interventions). The costs of each treatment procedure will be calculated and compared with thresholds values for intervention by region, determined by World Health Organization (http://www.who.int/choice/costs/CER_levels/ en/).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">168</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>WMP of fluoride varnish</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Whole mouth protocol group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TWLP of fluoride varnish</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tooth with lesion Protocol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DHP (educational intervention)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Diet and Hygiene guidance Protocol</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>WMP of fluoride varnish</intervention_name>
    <description>Application of fluoride varnish (drug of the intervention - Duraphat, Colgate) on all teeth, regardless of the lesions found</description>
    <arm_group_label>WMP of fluoride varnish</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TWLP of fluoride varnish</intervention_name>
    <description>application of the fluoride varnish (drug of the intervention - Duraphat, Colgate) only on the teeth with active initial caries lesions detected through visual examination after prophylaxis</description>
    <arm_group_label>TWLP of fluoride varnish</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DHP (educational intervention)</intervention_name>
    <description>The control group will receive diet and hygiene guidance (educational intervention) through verbal explanations and teeth brushing practices</description>
    <arm_group_label>DHP (educational intervention)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with active carious lesions scores 1, 2 or 3 of the ICDAS in deciduous teeth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with special needs;&#xD;
&#xD;
          -  Patients using orthodontic appliances;&#xD;
&#xD;
          -  systemic diseases;&#xD;
&#xD;
          -  Teeth that present restorations, sealants, formation defects, deep caries lesions that&#xD;
             may lead to pulp involvement, fistulae and / or abscesses;&#xD;
&#xD;
          -  teeth with spontaneous painful symptomatology.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidade Ibirapuera</name>
      <address>
        <city>Sao Paulo</city>
        <zip>04661100</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Ibirapuera</investigator_affiliation>
    <investigator_full_name>Tamara Kerber Tedesco</investigator_full_name>
    <investigator_title>PhD, Senior Lecturer</investigator_title>
  </responsible_party>
  <keyword>dental caries</keyword>
  <keyword>Tooth, Deciduous</keyword>
  <keyword>Fluorides, Topical</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>Individual participant data will be available on Mendeley database</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/NCT03827889
org study id: UNIB5
nct id: NCT03827889
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Evidence that the data flow analysis tests, there are still no studies that show the clarity
      of the protocols of its application, including the interval and execution factors of
      applications, concentration of fluoridation and previous prophylaxis. That is, there are
      still large gaps regarding fluoride varnish applications. Thus, the objective of the present
      project is the selection of two protocols for application of fluid applications in active
      drugs in primary tooth enamel. The longitudinal follow-up will be performed in a period of 3,
      6, 12, 18 and 24 months after the procedure. The progression of a subject will be evaluated
      clinically through the transition of ICDAS scores and assessment of the lesions (sound
      examination with superficial measurements) by visual examination, and the physician evaluates
      the efficacy and the ability to evaluate the therapeutic techniques and evaluation.
      treatment, cost and quality of life of participants
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PROGRESSION OF CARIES LESIONS (caries lesions inactivation assessment)
time frame: Every 6 months up to 24 months
description: Caries progression will be evaluated radiographically by three previously trained evaluators (through theoretical classes and evaluation of 13 clinical photographs) and calibrated. These examiners will not know the chronological order and compare the images two to two first by two evaluators and when there is disagreement between the two, the third examiner shall be called for tie-breaker. The possible progression of the treated caries lesion will be codified as:
Present progression: Change in radiolucidity area of the Lesion
Absent progression: No change in the area of radiolucidity of the lesion.
measure: Number of surfaces with NEW CARIES LESIONS
time frame: Up to 24 months
description: Detection of the presence of new lesions in deciduous and permanent teeth through visual inspection after dental cleaning. New lesions will be recorded using ICDAS scores.
measure: Children self-reported discomfort
time frame: baseline (Immediately after procedure)
description: The child's discomfort will be assessed immediately after the sequence of treatments performed in each session by the Wong-Baker face scale. Each face corresponds to a number in a numeric scale from 0 to 5, being 0 no discomfort and 5 maximum of discomfort. At the end, the averages of each score will be compared between the experimental groups.The patient will be asked to choose the face that is more similar to how he/she felt during the treatment. The answer should be given solely by the child, which means no parental or professional interferences.
measure: COST-EFFICACY of each protocol
time frame: up to 24 months
description: To evaluate the cost-efficacy of different protocols by total value in dollar of treatment in relation to efficacy.The quantities of all consumables used in each procedure will be annotated, as well as the time spent in each procedure, money and time will be combined to report the cost of procedures, measured by $/hour. In addition, we will verify the efficacy through the need for new surgical treatments or new caries lesions. In this way, we will compare the experimental groups according to the cost ($/hour) x the efficacy (need for new interventions). The costs of each treatment procedure will be calculated and compared with thresholds values for intervention by region, determined by World Health Organization (http://www.who.int/choice/costs/CER_levels/ en/).
arm group label: WMP of fluoride varnish
arm group type: Experimental
description: Whole mouth protocol group
arm group label: TWLP of fluoride varnish
arm group type: Experimental
description: Tooth with lesion Protocol
arm group label: DHP (educational intervention)
arm group type: Active Comparator
description: Diet and Hygiene guidance Protocol
intervention type: Procedure
intervention name: WMP of fluoride varnish
description: Application of fluoride varnish (drug of the intervention - Duraphat, Colgate) on all teeth, regardless of the lesions found
arm group label: WMP of fluoride varnish
intervention type: Procedure
intervention name: TWLP of fluoride varnish
description: application of the fluoride varnish (drug of the intervention - Duraphat, Colgate) only on the teeth with active initial caries lesions detected through visual examination after prophylaxis
arm group label: TWLP of fluoride varnish
intervention type: Behavioral
intervention name: DHP (educational intervention)
description: The control group will receive diet and hygiene guidance (educational intervention) through verbal explanations and teeth brushing practices
arm group label: DHP (educational intervention)
criteria: 
gender: All
minimum age: 4 Years
maximum age: 6 Years
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Ibirapuera
investigator full name: Tamara Kerber Tedesco
investigator title: PhD, Senior Lecturer
mesh term: Dental Caries
mesh term: Fluorides
mesh term: Fluorides, Topical
sharing ipd: Yes
ipd description: Individual participant data will be available on Mendeley database