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

Primary Purpose

Leukemia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dental Procedure
Educational Intervention (prevention education)
Interview
Survey Administration
Educational Intervention (one-on one education)
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Leukemia

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth University/Massey Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group I (standard prevention education)

Group II (standard and one-on-one education, consultation)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 7, 2017
Last Updated
February 21, 2020
Sponsor
Virginia Commonwealth University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03281746
Brief Title
Effect of Prevention Education in Caries Formation in Pediatric Patients With Leukemia
Official Title
Effect of Prevention Education on Factors of Importance in Caries Formation in Pediatric Patients With Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
May 19, 2017 (Actual)
Primary Completion Date
March 2, 2018 (Actual)
Study Completion Date
March 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (standard prevention education)
Arm Type
Active Comparator
Arm 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 Title
Group II (standard and one-on-one education, consultation)
Arm Type
Experimental
Arm 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(s)
Dental Procedure
Intervention Description
Undergo dental examination
Intervention Type
Other
Intervention Name(s)
Educational Intervention (prevention education)
Other Intervention Name(s)
Education for Intervention, Intervention by Education
Intervention Description
Receive prevention education
Intervention Type
Other
Intervention Name(s)
Interview
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Educational Intervention (one-on one education)
Other Intervention Name(s)
Education for Intervention, Educational Intervention, Intervention by Education, Intervention through Education
Intervention Description
Receive one-on-one education
Primary Outcome Measure Information:
Title
Change in caries assessed by CAMBRA risk assessment tool
Time Frame
Baseline up to 32 weeks
Title
Change in salivary flow rate
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.
Time Frame
Baseline up to 32 weeks
Title
Change in salivary pH
Description
Will be measured with litmus paper in the gingival sulcus of the tooth where plaque is collected for bacterial load testing.
Time Frame
Baseline up to 32 weeks
Title
Change in levels of mutans streptococci in buccal surface of most posterior maxillary right tooth
Description
Samples will be plated on mitis salivarius and incubated. Mutans streptococci colonies will be counted after incubation.
Time Frame
Baseline up to 32 weeks
Title
Change in caries assessed by Merged International Caries Detection and Assessment System (ICDAS)
Time Frame
Baseline up to 32 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helou A Marieka, MD, MPH
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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