Clinical trial NCT03281746: 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
Overall status: TERMINATED
Phase: NA
Conditions: Leukemia
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-09-13
Enrollment: 2
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in caries assessed by CAMBRA risk assessment tool
timeFrame: Baseline up to 32 weeks
measure: Change in salivary flow rate
timeFrame: Baseline up to 32 weeks
measure: Change in salivary pH
timeFrame: Baseline up to 32 weeks
measure: Change in levels of mutans streptococci in buccal surface of most posterior maxillary right tooth
timeFrame: Baseline up to 32 weeks
measure: Change in caries assessed by Merged International Caries Detection and Assessment System (ICDAS)
timeFrame: Baseline up to 32 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Helou A Marieka, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: