<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/NCT01707797</url>
  </required_header>
  <id_info>
    <org_study_id>NIDCR 11-101</org_study_id>
    <secondary_id>U01DE021412-01A1</secondary_id>
    <nct_id>NCT01707797</nct_id>
  </id_info>
  <brief_title>Predicting Caries Risk in Underserved Toddlers in Primary Healthcare Settings</brief_title>
  <official_title>Predicting Caries Risk in Underserved Toddlers in Primary Healthcare Settings A Stratified (by Race, Ethnicity, and Medicaid Status) Study to Develop a Caries Risk Prediction Questionnaire</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Dental and Craniofacial Research (NIDCR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to develop a questionnaire that can be used to help uncover a child's risk of&#xD;
      developing dental caries (also known as tooth decay or a cavity). The aim is to develop a&#xD;
      practical and easily-scored risk tool that a primary medical care provider can use to help&#xD;
      find young children with the highest risk for developing cavities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The duration of expected time to participate is 3 years (which includes 3 dental&#xD;
      examinations).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2012</start_date>
  <completion_date type="Actual">March 30, 2017</completion_date>
  <primary_completion_date type="Actual">March 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of any caries at baseline and incidence and/or progression of any caries lesions at follow up examinations</measure>
    <time_frame>3 years</time_frame>
    <description>Outcomes will be defined at the participant level.&#xD;
Presence of any caries at baseline (defined as ICDAS ≥ 3, filling, or missing due to caries).&#xD;
Incidence (ICDAS ≥ 3, filling, or missing due to caries) and/or progression (change from ICDAS= 3 or 4 to ICDAS=5 or 6, or filling, or missing due to caries) of any caries lesions at the follow-up examinations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of any caries at baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Presence of any caries at baseline (defined as ICDAS &gt; 0, which includes all early caries, filling, or missing due to caries). Presence of any caries at baseline (defined as ICDAS ≥ 5, which includes only frank cavitation, filling, or missing due to caries)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and/or progression of any caries lesions at the follow-up examinations.</measure>
    <time_frame>3 years</time_frame>
    <description>Incidence and/or progression of any caries lesions at the follow-up examinations. Progression is defined as change from ICDAS=0 to ICDAS=1 or higher, or filling, or missing due to caries; change from ICDAS=1 or 2 to ICDAS=3 or higher, or filling, or missing due to caries; or change from ICDAS=3 or 4 to ICDAS=5 or 6, or filling, or missing due to caries.&#xD;
Incidence of any caries lesions at the follow-up examinations. Because only distinct cavitation is included at baseline, no progression outcomes from baseline to follow-up will be defined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>counts of the number of carious surfaces</measure>
    <time_frame>3 years</time_frame>
    <description>Counts of the number of carious surfaces (dmfs), using ICDAS ≥ 3 to define decayed surfaces.&#xD;
Counts of the number of carious surfaces (dmfs), using ICDAS &gt; 0 to define decayed surfaces.&#xD;
Counts of the number of carious surfaces (dmfs), using ICDAS ≥ 5 to define decayed surfaces</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1326</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>Healthy children aged 9-15 months</arm_group_label>
    <description>Healthy children aged 12 months (± 3 months) at baseline stratified by Medicaid status and/or race/ethnicity to ensure a diverse representation. Each child will be paired with the primary caregiver, whom the investigators expect to most likely be the adult parent or legal guardian.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy children aged 12 months (± 3 months) at baseline stratified by Medicaid status&#xD;
        and/or race/ethnicity to ensure a diverse representation. Each child will be paired with&#xD;
        the primary caregiver, whom the investigators expect to most likely be the adult parent or&#xD;
        legal guardian.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adults&#xD;
&#xD;
          -  If Primary Caregiver is the Parent/Legal guardian: The parent/legal guardian must&#xD;
             provide written informed consent for the child and her/himself (if s/he is the primary&#xD;
             caregiver) prior to participation.&#xD;
&#xD;
          -  If Primary Caregiver is not the Parent/Legal Guardian: If another individual is the&#xD;
             primary caregiver, then this individual must provide written informed consent for&#xD;
             her/himself prior to participation.&#xD;
&#xD;
          -  The parent/legal guardian and the participating primary caregiver must each be at&#xD;
             least 18 years old or an emancipated minor&#xD;
&#xD;
          -  The parent/legal guardian must consent and allow examination of the oral cavity of&#xD;
             her/his child. The primary caregiver must complete the caries risk assessment&#xD;
             questionnaire.&#xD;
&#xD;
          -  The primary caregiver must be willing to participate, anticipate being the child's&#xD;
             primary caregiver during the study period, and anticipate being available for all&#xD;
             examinations (baseline, 18 month follow up, and 36 month follow up), in addition to&#xD;
             intermediate contacts in between examinations.&#xD;
&#xD;
        Children&#xD;
&#xD;
          -  Child must be 9-15 months of age at the time of the baseline study visit.&#xD;
&#xD;
          -  Child must be generally healthy (i.e., no current medical condition that makes it&#xD;
             difficult for her/him to receive a dental examination).&#xD;
&#xD;
          -  Child must allow examination of the oral cavity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Adults&#xD;
&#xD;
          -  A participant pair (adult-child) who demonstrates an inability to comply with study&#xD;
             protocol requirements will be excluded - this determination will be at the Site&#xD;
             Primary Investigator's discretion.&#xD;
&#xD;
          -  Non-English, non-Spanish reading/speaking individuals will be excluded, as they will&#xD;
             not be able to comprehend the consent document or complete the risk questionnaire.&#xD;
&#xD;
        Children&#xD;
&#xD;
          -  Children who are in foster care at study initiation will be excluded, due to the&#xD;
             likelihood that their primary caregiver will change multiple times during the length&#xD;
             of the study.&#xD;
&#xD;
          -  Need for antibiotic and/or sedative premedication prior to dental exam.&#xD;
&#xD;
          -  Uncontrolled epilepsy.&#xD;
&#xD;
          -  Active cancer treatment.&#xD;
&#xD;
          -  Unrepaired congenital heart defects that would require premedication prior to dental&#xD;
             exam.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Months</minimum_age>
    <maximum_age>15 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Margherita Fontana, DDS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indiana University Oral Health Research Institute</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Health Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>September 14, 2018</last_update_submitted>
  <last_update_submitted_qc>September 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Margherita Fontana, DDS, PhD</investigator_full_name>
    <investigator_title>Professor Cariology Discipline Co-coordinator</investigator_title>
  </responsible_party>
  <keyword>dental caries</keyword>
  <keyword>high risk</keyword>
  <keyword>dental cavities</keyword>
  <keyword>children dental care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</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/NCT01707797
org study id: NIDCR 11-101
secondary id: U01DE021412-01A1
nct id: NCT01707797
lead sponsor: 
collaborator: 
has dmc: Yes
The study aims to develop a questionnaire that can be used to help uncover a child's risk of
      developing dental caries (also known as tooth decay or a cavity). The aim is to develop a
      practical and easily-scored risk tool that a primary medical care provider can use to help
      find young children with the highest risk for developing cavities.
The duration of expected time to participate is 3 years (which includes 3 dental
      examinations).
observational model: Cohort
time perspective: Prospective
measure: Presence of any caries at baseline and incidence and/or progression of any caries lesions at follow up examinations
time frame: 3 years
description: Outcomes will be defined at the participant level.
Presence of any caries at baseline (defined as ICDAS ≥ 3, filling, or missing due to caries).
Incidence (ICDAS ≥ 3, filling, or missing due to caries) and/or progression (change from ICDAS= 3 or 4 to ICDAS=5 or 6, or filling, or missing due to caries) of any caries lesions at the follow-up examinations.
measure: Presence of any caries at baseline
time frame: Baseline
description: Presence of any caries at baseline (defined as ICDAS > 0, which includes all early caries, filling, or missing due to caries). Presence of any caries at baseline (defined as ICDAS ≥ 5, which includes only frank cavitation, filling, or missing due to caries)
measure: Incidence and/or progression of any caries lesions at the follow-up examinations.
time frame: 3 years
description: Incidence and/or progression of any caries lesions at the follow-up examinations. Progression is defined as change from ICDAS=0 to ICDAS=1 or higher, or filling, or missing due to caries; change from ICDAS=1 or 2 to ICDAS=3 or higher, or filling, or missing due to caries; or change from ICDAS=3 or 4 to ICDAS=5 or 6, or filling, or missing due to caries.
Incidence of any caries lesions at the follow-up examinations. Because only distinct cavitation is included at baseline, no progression outcomes from baseline to follow-up will be defined.
measure: counts of the number of carious surfaces
time frame: 3 years
description: Counts of the number of carious surfaces (dmfs), using ICDAS ≥ 3 to define decayed surfaces.
Counts of the number of carious surfaces (dmfs), using ICDAS > 0 to define decayed surfaces.
Counts of the number of carious surfaces (dmfs), using ICDAS ≥ 5 to define decayed surfaces
arm group label: Healthy children aged 9-15 months
description: Healthy children aged 12 months (± 3 months) at baseline stratified by Medicaid status and/or race/ethnicity to ensure a diverse representation. Each child will be paired with the primary caregiver, whom the investigators expect to most likely be the adult parent or legal guardian.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 9 Months
maximum age: 15 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Margherita Fontana, DDS, PhD
role: Principal Investigator
affiliation: University of Michigan
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Margherita Fontana, DDS, PhD
investigator title: Professor Cariology Discipline Co-coordinator
mesh term: Dental Caries