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

Not Applicable

Terminated

• Conditions: Leukemia
• Interventions: Procedure: Dental Procedure; Other: Educational Intervention (prevention education); Other: Interview; Other: Survey Administration; Other: Educational Intervention (one-on one education)

• Registration Number: NCT03281746
• Lead Sponsor: Virginia Commonwealth University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-05-19
• Study First Submitted: 2017-09-07
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-13
• Primary Completion: 2018-03-02
• Study Completion: 2018-03-02
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (standard and one-on-one education, consultation)	Survey Administration	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.
Group II (standard and one-on-one education, consultation)	Dental Procedure	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.
Group II (standard and one-on-one education, consultation)	Educational Intervention (prevention education)	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.
Group II (standard and one-on-one education, consultation)	Educational Intervention (one-on one education)	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.
Group I (standard prevention education)	Interview	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.
Group I (standard prevention education)	Educational Intervention (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.
Group I (standard prevention education)	Dental Procedure	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.
Group I (standard prevention education)	Survey Administration	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.
Group II (standard and one-on-one education, consultation)	Interview	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.

Primary Outcome Measures

Name	Time	Method
Change in levels of mutans streptococci in buccal surface of most posterior maxillary right tooth	Baseline up to 32 weeks	Samples will be plated on mitis salivarius and incubated. Mutans streptococci colonies will be counted after incubation.
Change in salivary flow rate	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.
Change in caries assessed by CAMBRA risk assessment tool	Baseline up to 32 weeks
Change in caries assessed by Merged International Caries Detection and Assessment System (ICDAS)	Baseline up to 32 weeks
Change in salivary pH	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.

Trial Locations

Locations (1)

Virginia Commonwealth University/Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States