<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/NCT03281746</url>
  </required_header>
  <id_info>
    <org_study_id>MCC-16-13019</org_study_id>
    <secondary_id>NCI-2017-01354</secondary_id>
    <nct_id>NCT03281746</nct_id>
  </id_info>
  <brief_title>Effect of Prevention Education in Caries Formation in Pediatric Patients With Leukemia</brief_title>
  <official_title>Effect of Prevention Education on Factors of Importance in Caries Formation in Pediatric Patients With Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Virginia Commonwealth University</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>
      This randomized pilot clinical trial studies how well preventive education works in&#xD;
      decreasing caries formation in pediatric patients with leukemia. Prevention education may&#xD;
      have an effect on factors important in causing cavities in pediatric patients with leukemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients treated for leukemia at Virginia Commonwealth University Medical Center in the&#xD;
      department of Pediatric Hematology and Oncology are currently receiving oral hygiene&#xD;
      instruction at diagnosis. In this study, patients will be randomized into two groups at&#xD;
      diagnosis: one receiving current prevention education and the other group receiving&#xD;
      one-on-one prevention education and counseling with the physician and pediatric dental&#xD;
      resident. Physician and pediatric dental resident will use motivational interviewing informed&#xD;
      techniques during counseling. A caries risk assessment will be performed for each patient at&#xD;
      diagnosis. Caries incidence, plaque scores, mutans streptococci levels, salivary flow rate,&#xD;
      and salivary pH will be assessed at week one (diagnosis), week 16 or start of interim&#xD;
      maintenance therapy whichever comes second, week 32 or beginning of maintenance therapy&#xD;
      whichever is later for all patients enrolled in the study. Data will be collected through a&#xD;
      clinical intraoral examination and salivary sample. Data collected will be used to assess the&#xD;
      effect of increased prevention education on factors of importance in caries formation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow accrual&#xD;
  </why_stopped>
  <start_date type="Actual">May 19, 2017</start_date>
  <completion_date type="Actual">March 2, 2018</completion_date>
  <primary_completion_date type="Actual">March 2, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in caries assessed by CAMBRA risk assessment tool</measure>
    <time_frame>Baseline up to 32 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in salivary flow rate</measure>
    <time_frame>Baseline up to 32 weeks</time_frame>
    <description>Change in salivary flow rate will be measured utilizing pre-weighed cotton rolls. Patients will saturate as many cotton rolls as possible in one minute by chewing. Dose cups and cotton rolls will be weighed prior to and after data collection. The change in weight in grams will be converted to mL of saliva collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in salivary pH</measure>
    <time_frame>Baseline up to 32 weeks</time_frame>
    <description>Will be measured with litmus paper in the gingival sulcus of the tooth where plaque is collected for bacterial load testing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in levels of mutans streptococci in buccal surface of most posterior maxillary right tooth</measure>
    <time_frame>Baseline up to 32 weeks</time_frame>
    <description>Samples will be plated on mitis salivarius and incubated. Mutans streptococci colonies will be counted after incubation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in caries assessed by Merged International Caries Detection and Assessment System (ICDAS)</measure>
    <time_frame>Baseline up to 32 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Leukemia</condition>
  <arm_group>
    <arm_group_label>Group I (standard prevention education)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergo dental examination at baseline and then receive standard prevention education at diagnosis discussing the effects of prolonged neutropenia on oral hygiene, importance of a regular oral hygiene regimen, and the long term clinical outcomes of oncologic patients. Patients also receive fliers with pictograms describing proper brushing, use of mouth wash, and common oral complications during therapy, as well as a bottle and prescription for chlorhexidine gluconate 0.12% rinse.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (standard and one-on-one education, consultation)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo dental examination and receive standard prevention education as in Group I. Patients also receive one-on-one prevention education and counseling with the physician and pediatric dental resident.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dental Procedure</intervention_name>
    <description>Undergo dental examination</description>
    <arm_group_label>Group I (standard prevention education)</arm_group_label>
    <arm_group_label>Group II (standard and one-on-one education, consultation)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational Intervention (prevention education)</intervention_name>
    <description>Receive prevention education</description>
    <arm_group_label>Group I (standard prevention education)</arm_group_label>
    <arm_group_label>Group II (standard and one-on-one education, consultation)</arm_group_label>
    <other_name>Education for Intervention</other_name>
    <other_name>Intervention by Education</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interview</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I (standard prevention education)</arm_group_label>
    <arm_group_label>Group II (standard and one-on-one education, consultation)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I (standard prevention education)</arm_group_label>
    <arm_group_label>Group II (standard and one-on-one education, consultation)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational Intervention (one-on one education)</intervention_name>
    <description>Receive one-on-one education</description>
    <arm_group_label>Group II (standard and one-on-one education, consultation)</arm_group_label>
    <other_name>Education for Intervention</other_name>
    <other_name>Educational Intervention</other_name>
    <other_name>Intervention by Education</other_name>
    <other_name>Intervention through Education</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients who have been recently diagnosed with leukemia&#xD;
&#xD;
          -  Patients will also predictably be in primary or mixed dentition&#xD;
&#xD;
          -  Patients of Virginia Commonwealth University Medical Center Pediatric Hematology&#xD;
             Oncology Clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Full permanent dentition&#xD;
&#xD;
          -  Primary language is not English&#xD;
&#xD;
          -  Children in the custody of the state with no parent or legal guardian present to sign&#xD;
             consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helou A Marieka, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virginia Commonwealth University/Massey Cancer Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>February 21, 2020</last_update_submitted>
  <last_update_submitted_qc>February 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</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/NCT03281746
org study id: MCC-16-13019
secondary id: NCI-2017-01354
nct id: NCT03281746
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized pilot clinical trial studies how well preventive education works in
      decreasing caries formation in pediatric patients with leukemia. Prevention education may
      have an effect on factors important in causing cavities in pediatric patients with leukemia.
Patients treated for leukemia at Virginia Commonwealth University Medical Center in the
      department of Pediatric Hematology and Oncology are currently receiving oral hygiene
      instruction at diagnosis. In this study, patients will be randomized into two groups at
      diagnosis: one receiving current prevention education and the other group receiving
      one-on-one prevention education and counseling with the physician and pediatric dental
      resident. Physician and pediatric dental resident will use motivational interviewing informed
      techniques during counseling. A caries risk assessment will be performed for each patient at
      diagnosis. Caries incidence, plaque scores, mutans streptococci levels, salivary flow rate,
      and salivary pH will be assessed at week one (diagnosis), week 16 or start of interim
      maintenance therapy whichever comes second, week 32 or beginning of maintenance therapy
      whichever is later for all patients enrolled in the study. Data will be collected through a
      clinical intraoral examination and salivary sample. Data collected will be used to assess the
      effect of increased prevention education on factors of importance in caries formation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in caries assessed by CAMBRA risk assessment tool
time frame: Baseline up to 32 weeks
measure: Change in salivary flow rate
time frame: Baseline up to 32 weeks
description: Change in salivary flow rate will be measured utilizing pre-weighed cotton rolls. Patients will saturate as many cotton rolls as possible in one minute by chewing. Dose cups and cotton rolls will be weighed prior to and after data collection. The change in weight in grams will be converted to mL of saliva collected.
measure: Change in salivary pH
time frame: Baseline up to 32 weeks
description: Will be measured with litmus paper in the gingival sulcus of the tooth where plaque is collected for bacterial load testing.
measure: Change in levels of mutans streptococci in buccal surface of most posterior maxillary right tooth
time frame: Baseline up to 32 weeks
description: Samples will be plated on mitis salivarius and incubated. Mutans streptococci colonies will be counted after incubation.
measure: Change in caries assessed by Merged International Caries Detection and Assessment System (ICDAS)
time frame: Baseline up to 32 weeks
arm group label: Group I (standard prevention education)
arm group type: Active Comparator
description: Patients undergo dental examination at baseline and then receive standard prevention education at diagnosis discussing the effects of prolonged neutropenia on oral hygiene, importance of a regular oral hygiene regimen, and the long term clinical outcomes of oncologic patients. Patients also receive fliers with pictograms describing proper brushing, use of mouth wash, and common oral complications during therapy, as well as a bottle and prescription for chlorhexidine gluconate 0.12% rinse.
arm group label: Group II (standard and one-on-one education, consultation)
arm group type: Experimental
description: Patients undergo dental examination and receive standard prevention education as in Group I. Patients also receive one-on-one prevention education and counseling with the physician and pediatric dental resident.
intervention type: Procedure
intervention name: Dental Procedure
description: Undergo dental examination
arm group label: Group I (standard prevention education)
arm group label: Group II (standard and one-on-one education, consultation)
intervention type: Other
intervention name: Educational Intervention (prevention education)
description: Receive prevention education
arm group label: Group I (standard prevention education)
arm group label: Group II (standard and one-on-one education, consultation)
other name: Education for Intervention
other name: Intervention by Education
intervention type: Other
intervention name: Interview
description: Ancillary studies
arm group label: Group I (standard prevention education)
arm group label: Group II (standard and one-on-one education, consultation)
intervention type: Other
intervention name: Survey Administration
description: Ancillary studies
arm group label: Group I (standard prevention education)
arm group label: Group II (standard and one-on-one education, consultation)
intervention type: Other
intervention name: Educational Intervention (one-on one education)
description: Receive one-on-one education
arm group label: Group II (standard and one-on-one education, consultation)
other name: Education for Intervention
other name: Educational Intervention
other name: Intervention by Education
other name: Intervention through Education
criteria: 
gender: All
minimum age: 3 Years
maximum age: 12 Years
healthy volunteers: No
last name: Helou A Marieka, MD, MPH
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Leukemia