Clinical Drug Experience Knowledgebase

This research proposal is unique in that it compares two different methods of applying neutral sodium fluoride to prevent dental caries and improve compliance in this at-risk population. Given that compliance with use of fluoride trays has historically been poor, there is controversy as to which application method is best. Further, the optimal dosage regimen is unknown. Clarification is needed to support best practices.

Data from the proposed study will help to identify an effective and tolerated form of fluoride delivery in patients undergoing head and neck radiation therapy. If our hypotheses are supported, additional studies will be undertaken with a larger sample size, and expanded to include patients with head and neck cancers treated with chemotherapy or a combination of cancer therapies.

All patients will undergo an initial dental visit, which will consist of medical consultation with the patient's oncologist and standard dental and radiographic examinations. Patients will return to have existing dental disease treated (eg. caries, gingival disease, extractions). When treatment is complete, they will be invited to participate in the study. The Screening Form will be used to confirm eligibility.

Study Visit #1 (Baseline) After obtaining consent, subjects will be randomly assigned to receive fluoride therapy with either custom trays (Tray group) or by application with a toothbrush (Brush group). Each subject will undergo a basic dental examination for identification of new carious lesions. Visit #1 is the baseline, with a new caries score of zero. Photographs will be taken of the subject's mouth and instructions for fluoride therapy will be given.

Tray group: The subject will have custom vinyl vacuform fluoride trays made using an in-house laboratory. They will be instructed to apply a "ribbon" of fluoride gel into each tray, and then to wear each tray for 5 minutes, one tray at a time, after which the subject will expectorate any remaining fluoride from the mouth.

Brush group: The subject will be instructed to apply a "ribbon" of fluoride gel onto the toothbrush provided (Colgate Wave Sensitive) and to brush with the fluoride for 2 minutes at bedtime.

Both groups: The subject may not rinse, eat, or drink for 30 minutes after the fluoride treatment.

All subjects will be instructed to perform their fluoride therapy at bedtime and to document the date and time of treatment on the Monthly Fluoride Log. All subjects will be provided with 1.1% neutral sodium fluoride (PreviDent®) gel for the duration of the study. All subjects will be instructed to return their monthly fluoride logs and any remaining fluoride at each study visit.

Subjects will return for a follow-up examination at 3, 6, 9, and 12 months from the first study visit. At each visit, the following procedures will be conducted:

Update medical history
Take photographs
Conduct examination for caries
Assess compliance with fluoride therapy
Collect fluoride log for previous 3 months
Dispense new fluoride log
Collect and weigh returned fluoride tube
Weigh and dispense new fluoride tube
Dispense new toothbrush (Brush group only)

Subjects will be scheduled to immediately return to have any new carious lesions filled.

To evaluate compliance, subjects will be asked about their fluoride use according to standard methods utilized by other experts in the field. High compliance is defined as daily use; low compliance is defined as two to three times per week; not compliant is defined as less than two times per week.

To evaluate caries incidence, the number of surfaces per tooth on which new caries appear will be documented on the Caries Assessment Form. Caries will be scored using the International Caries Classification and Management System criteria for clinical research. Surfaces will be scored as either I (no obvious decay) or II (obvious decay). Bitewing radiographs and periapical films (as needed) will be taken at 6 and 12 months after the initial examination visit.

Descriptive statistics, including means (standard deviations) or counts (percentages), as appropriate, will be used to summarize baseline demographic and clinical characteristics of the two groups.