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

Virginia Commonwealth University (VCU)

Status: Terminated

Conditions: Leukemia

Treatments: Other: Interview; Other: Survey Administration; Other: Educational Intervention (prevention education); Other: Educational Intervention (one-on one education); Procedure: Dental Procedure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03281746

NCI-2017-01354 (Registry Identifier)

MCC-16-13019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Group I (standard prevention education)

Active Comparator group

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.

Treatment:

Other: Survey Administration

Other: Educational Intervention (prevention education)

Other: Interview

Procedure: Dental Procedure

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

Experimental group

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.

Treatment:

Other: Educational Intervention (one-on one education)

Other: Survey Administration

Other: Educational Intervention (prevention education)

Other: Interview

Procedure: Dental Procedure