<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/NCT02263768</url>
  </required_header>
  <id_info>
    <org_study_id>7709191</org_study_id>
    <nct_id>NCT02263768</nct_id>
  </id_info>
  <brief_title>Impact of Two Recall Intervals on Dental Caries Incidence, Anxiety and Quality of Life of Preschool Children</brief_title>
  <official_title>Impact of Two Recall Intervals Associated to Oral Health Counseling on Dental Caries Incidence, Anxiety and Quality of Life of Preschool Children With Low and Moderate Caries Risk: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives: To assess the effectiveness of two recall intervals on dental caries incidence&#xD;
      (primary outcome) in preschool children with low and moderate caries risk. The level of&#xD;
      anxiety, oral health related quality of life (OHRQoL), time and cost (secondary outcomes)&#xD;
      according to each interval will also be assessed. Methods: The sample will consist of 224&#xD;
      children between 3-5 years of age, of both genders, with low and moderate caries risk&#xD;
      according to the clinical criteria adapted from the Secretary of Health of São Paulo.&#xD;
      Children will be randomly allocated into two study groups: Group 1 (G1) - oral clinical&#xD;
      examination + orientation for oral health and diet on the recall of 12 months; and Group 2&#xD;
      (G2) - oral clinical examination + orientation for oral health and diet on the recall of 18&#xD;
      months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An examiner calibrated and blinded to the study groups and the secondary outcomes will&#xD;
      perform the clinical examinations, which consist of: the gingival bleeding index, dental&#xD;
      plaque index, detection of caries and its activity according to the ICDAS (International&#xD;
      Caries Detection and Assessment System) and the clinical features of active and inactive&#xD;
      caries lesions will be associated with the criteria discribed in ICDAS Commitee manual. An&#xD;
      external dentist will conduct the assessment of the anxiety levels assessed by the Facial&#xD;
      Image Scale, the OHRQoL measured by B-ECOHIS (Brazilian Early Childhood Oral Health Impact&#xD;
      Scale), the time and costs. All groups will be followed for a period of 36 months. All&#xD;
      analyzes will be performed with the intention of treatment (ITT) and considering the&#xD;
      sensitivity analyzes to assess the differences between the ITT analyzes and the complete&#xD;
      cases analyzes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2015</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</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>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dental caries incidence - Change</measure>
    <time_frame>Baseline, 12 months and 18 months</time_frame>
    <description>Dental caries will be assessed using the ICDAS criteria (Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, et al. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol 2007; 35: 170-8).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of anxiety - Change</measure>
    <time_frame>Baseline, 12 months and 18 months</time_frame>
    <description>Level of anxiety will be assessed using the Facial Image Scale (Buchanan H, Niven N. Validation of a facial image scale to assess child dental anxiety. Int J Paediatr Dent 2002;12:47-52).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral health related quality of life - Change</measure>
    <time_frame>Baseline, 12 months and 18 months</time_frame>
    <description>Oral health related quality of life will be assessed using the Brazilian validation of the ECOHIS (Scarpelli AC, Oliveira BH, Tesch FC, Leão AT, Pordeus IA, Paiva SM. Psychometric properties of the Brazilian version of the Early Childhood Oral Health Impact Scale (B-ECOHIS). BMC Oral Health. 2011; 11:19).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time</measure>
    <time_frame>Baseline, 12 months and 18 months</time_frame>
    <description>The time in minutes, used in the recall interval visits, will be recorded in four categories: time spent on clinical examination including prophylaxis, hygiene and diet orientations, and time spent when the patient miss the recall visit. The total time will correspond to the sum of these categories.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs</measure>
    <time_frame>Baseline, 12 months and 18 months</time_frame>
    <description>Costs in real (continuous variable) will be recorded in two categories: salary of the dentist and dental assistant paid in public dental services in São Paulo, cost of dental materials/products used in the appointment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">224</enrollment>
  <condition>Dental Caries</condition>
  <condition>Quality of Life</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Group 1 - Recall Interval of 12 months</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Oral clinical conditions:&#xD;
Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 - Recall Interval of 18 months</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Oral clinical conditions:&#xD;
Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Oral clinical conditions</intervention_name>
    <description>Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment</description>
    <arm_group_label>Group 1 - Recall Interval of 12 months</arm_group_label>
    <arm_group_label>Group 2 - Recall Interval of 18 months</arm_group_label>
    <other_name>Caries incidence</other_name>
    <other_name>dental anxiety</other_name>
    <other_name>oral health related quality of life</other_name>
    <other_name>time and costs</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children between 3-5 years of age, of both genders, with low and moderate caries risk&#xD;
             according to the clinical criteria adapted from the Secretary of Health of São Paulo.&#xD;
&#xD;
          -  Guardians who have signed the informed consent confirming their participation and&#xD;
             their child in research.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children showing visible dental plaque and gingivitis in baseline.&#xD;
&#xD;
          -  Children showing more than 08 active and/or inactive caries cavitated surfaces, and&#xD;
             who show fistula and/or dental abscess.&#xD;
&#xD;
          -  Special patients.&#xD;
&#xD;
          -  Children who received professional application of fluoride in the 6 months prior to&#xD;
             the survey.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcelo Bönecker, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>University of São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dental School of University of São Paulo</name>
      <address>
        <city>São Paulo</city>
        <zip>05508-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>April 17, 2019</last_update_submitted>
  <last_update_submitted_qc>April 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Gabriela Oliveira Berti</investigator_full_name>
    <investigator_title>PhD student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT02263768
org study id: 7709191
nct id: NCT02263768
lead sponsor: 
has dmc: Yes
Objectives: To assess the effectiveness of two recall intervals on dental caries incidence
      (primary outcome) in preschool children with low and moderate caries risk. The level of
      anxiety, oral health related quality of life (OHRQoL), time and cost (secondary outcomes)
      according to each interval will also be assessed. Methods: The sample will consist of 224
      children between 3-5 years of age, of both genders, with low and moderate caries risk
      according to the clinical criteria adapted from the Secretary of Health of São Paulo.
      Children will be randomly allocated into two study groups: Group 1 (G1) - oral clinical
      examination + orientation for oral health and diet on the recall of 12 months; and Group 2
      (G2) - oral clinical examination + orientation for oral health and diet on the recall of 18
      months.
An examiner calibrated and blinded to the study groups and the secondary outcomes will
      perform the clinical examinations, which consist of: the gingival bleeding index, dental
      plaque index, detection of caries and its activity according to the ICDAS (International
      Caries Detection and Assessment System) and the clinical features of active and inactive
      caries lesions will be associated with the criteria discribed in ICDAS Commitee manual. An
      external dentist will conduct the assessment of the anxiety levels assessed by the Facial
      Image Scale, the OHRQoL measured by B-ECOHIS (Brazilian Early Childhood Oral Health Impact
      Scale), the time and costs. All groups will be followed for a period of 36 months. All
      analyzes will be performed with the intention of treatment (ITT) and considering the
      sensitivity analyzes to assess the differences between the ITT analyzes and the complete
      cases analyzes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Dental caries incidence - Change
time frame: Baseline, 12 months and 18 months
description: Dental caries will be assessed using the ICDAS criteria (Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, et al. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol 2007; 35: 170-8).
measure: Level of anxiety - Change
time frame: Baseline, 12 months and 18 months
description: Level of anxiety will be assessed using the Facial Image Scale (Buchanan H, Niven N. Validation of a facial image scale to assess child dental anxiety. Int J Paediatr Dent 2002;12:47-52).
measure: Oral health related quality of life - Change
time frame: Baseline, 12 months and 18 months
description: Oral health related quality of life will be assessed using the Brazilian validation of the ECOHIS (Scarpelli AC, Oliveira BH, Tesch FC, Leão AT, Pordeus IA, Paiva SM. Psychometric properties of the Brazilian version of the Early Childhood Oral Health Impact Scale (B-ECOHIS). BMC Oral Health. 2011; 11:19).
measure: Time
time frame: Baseline, 12 months and 18 months
description: The time in minutes, used in the recall interval visits, will be recorded in four categories: time spent on clinical examination including prophylaxis, hygiene and diet orientations, and time spent when the patient miss the recall visit. The total time will correspond to the sum of these categories.
measure: Costs
time frame: Baseline, 12 months and 18 months
description: Costs in real (continuous variable) will be recorded in two categories: salary of the dentist and dental assistant paid in public dental services in São Paulo, cost of dental materials/products used in the appointment.
arm group label: Group 1 - Recall Interval of 12 months
arm group type: Other
description: Oral clinical conditions:
Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment
arm group label: Group 2 - Recall Interval of 18 months
arm group type: Other
description: Oral clinical conditions:
Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment
intervention type: Procedure
intervention name: Oral clinical conditions
description: Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment
arm group label: Group 1 - Recall Interval of 12 months
arm group label: Group 2 - Recall Interval of 18 months
other name: Caries incidence
other name: dental anxiety
other name: oral health related quality of life
other name: time and costs
criteria: 
gender: All
minimum age: 3 Years
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marcelo Bönecker, Professor
role: Study Chair
affiliation: University of São Paulo
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Gabriela Oliveira Berti
investigator title: PhD student
mesh term: Dental Caries
mesh term: Anxiety Disorders