Effect of Prevention Education in Caries Formation in Pediatric Patients With Leukemia

February 21, 2020 updated by: Virginia Commonwealth University

Effect of Prevention Education on Factors of Importance in Caries Formation in Pediatric Patients With Leukemia

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University/Massey Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pediatric patients who have been recently diagnosed with leukemia
  • Patients will also predictably be in primary or mixed dentition
  • Patients of Virginia Commonwealth University Medical Center Pediatric Hematology Oncology Clinic

Exclusion Criteria:

  • Full permanent dentition
  • Primary language is not English
  • Children in the custody of the state with no parent or legal guardian present to sign consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I (standard prevention education)
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.
Other: Survey Administration
Ancillary studies
Other: Interview
Ancillary studies
Procedure: Dental Procedure
Undergo dental examination
Other: Educational Intervention (prevention education)
Receive prevention education
Other Names:
  • Education for Intervention
  • Intervention by Education
Experimental: Group II (standard and one-on-one education, consultation)
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.
Other: Survey Administration
Ancillary studies
Other: Interview
Ancillary studies
Procedure: Dental Procedure
Undergo dental examination
Other: Educational Intervention (prevention education)
Receive prevention education
Other Names:
  • Education for Intervention
  • Intervention by Education
Other: Educational Intervention (one-on one education)
Receive one-on-one education
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Educational Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in caries assessed by CAMBRA risk assessment tool
Time Frame: Baseline up to 32 weeks
Baseline up to 32 weeks
Change in salivary flow rate
Time Frame: Baseline up to 32 weeks
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.
Baseline up to 32 weeks
Change in salivary pH
Time Frame: Baseline up to 32 weeks
Will be measured with litmus paper in the gingival sulcus of the tooth where plaque is collected for bacterial load testing.
Baseline up to 32 weeks
Change in levels of mutans streptococci in buccal surface of most posterior maxillary right tooth
Time Frame: Baseline up to 32 weeks
Samples will be plated on mitis salivarius and incubated. Mutans streptococci colonies will be counted after incubation.
Baseline up to 32 weeks
Change in caries assessed by Merged International Caries Detection and Assessment System (ICDAS)
Time Frame: Baseline up to 32 weeks
Baseline up to 32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Helou A Marieka, MD, MPH, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2017

Primary Completion (Actual)

March 2, 2018

Study Completion (Actual)

March 2, 2018

Study Registration Dates

First Submitted

September 7, 2017

First Submitted That Met QC Criteria

September 11, 2017

First Posted (Actual)

September 13, 2017

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-16-13019
  • NCI-2017-01354 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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