Impact of Compliance With Fluoride Use on Caries Incidence After Cancer Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Fluoride use compliance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Diagnosis of cancer in the head and neck region
- •Field of radiation must include the parotid gland(s) and/or submandibular gland region
- •Able to speak English
- •Able to provide consent
- •Able to return for all study visits
排除标准
- •Previous/current use of prescription strength fluoride
- •Previous history of radiation to the head and neck region
- •Presence of autoimmune disease(s)
- •Currently pregnant
- •Currently edentulous or will become edentulous prior to beginning radiation therapy
结局指标
主要结局
Fluoride use compliance
时间窗: 12 months
To evaluate compliance, subjects will be asked about their fluoride use according to methods described by Epstein et al. (1996). 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.
次要结局
- Dental caries incidence assessed at 4 time points(12 months)
- Dental caries incidence assessed clinically at 4 time points(6 months)
研究者
Seena Patel
Dentist, Associate Director of Oral Medicine and Assistant Professor
A.T. Still University of Health Sciences