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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03281746
• Other study ID #: MCC-16-13019
• Secondary ID: NCI-2017-01354
• Status: Terminated
• Phase: N/A
• Start date: May 19, 2017
• Est. completion date: March 2, 2018

Study information

• Verified date: February 2020
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 2, 2018
• Est. primary completion date: March 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia

Intervention

Procedure:
• Dental Procedure
Undergo dental examination

Other:
• Educational Intervention (prevention education)
Receive prevention education
• Interview
Ancillary studies
• Survey Administration
Ancillary studies
• Educational Intervention (one-on one education)
Receive one-on-one education

Locations

Country	Name	City	State
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in caries assessed by CAMBRA risk assessment tool		Baseline up to 32 weeks
Primary	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.	Baseline up to 32 weeks
Primary	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.	Baseline up to 32 weeks
Primary	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.	Baseline up to 32 weeks
Primary	Change in caries assessed by Merged International Caries Detection and Assessment System (ICDAS)		Baseline up to 32 weeks