Impact of Compliance With Fluoride Use on Caries Incidence After Cancer Therapy
Condition: Dental Caries; Oral Cavity Cancer; Oral Complications of Chemotherapy and Head/Neck Radiation
MeSH terms: Mouth Neoplasms; Dental Caries
Study type: Interventional

Summary: 
      Approximately 40 people will participate in this study. This study will compare two different
      methods of fluoride application. Both methods are currently used in dental practice and both
      have been shown to be effective. If the participant chooses to participate in this study,
      participant will be asked to either wear a small tray that has been custom made to fit into
      the mouth into which fluoride is placed and worn for 5 minutes at bedtime, or participant
      will be asked to brush fluoride onto the teeth for 2 minutes at bedtime. Participant will be
      randomly assigned to use one of these methods of fluoride application: participant will not
      be allowed to choose which method of application you prefer. Participant will be asked to use
      fluoride every night while enrolled in the study. The fluoride that is used in the study is
      approved by the United States Food and Drug Administration and is commercially available with
      a prescription. After the study is over, participant will need to continue to use fluoride
      every night for life to help reduce the risk for dental cavities in the future.

      During the study, participant will receive a dental examination every 3 months for a total of
      4 study visits over the period of 1 year. This visit will consist of a dental examination to
      identify any new cavities and instructions for fluoride use. Participant will also be asked
      to complete a written log to document daily fluoride use and to give feedback about
      compliance with fluoride use.
    

Detailed description: 
      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.
    

Intervention name(s): Tray; Brush
Intervention type(s): Other; Other
Intervention description(s): Control intervention Patients will use the custom-made tray to apply the fluoride locally to the teeth and wear for 5 minutes each day.; Patients will brush with the fluoride for 2 minutes each day.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomly assigned to receive fluoride therapy with either custom trays (Tray group) or by application with a toothbrush (Brush group).
Masking: None (Open Label)
Primary purpose: Prevention