Clinical trial · Interventional
Impact of Compliance With Fluoride Use on Caries Incidence After Cancer Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dental Caries | — | UNRESOLVED | — |
| Oral Cavity Cancer | Malignant Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oral Complications of Chemotherapy and Head/Neck Radiation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brush | Other | — | UNRESOLVED |
| Tray | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tray group
- description
- Control intervention Patients will use the custom-made tray to apply the fluoride locally to the teeth and wear for 5 minutes each day.
- interventionNames
- Other: Tray
- type
- ACTIVE_COMPARATOR
- label
- Brush group
- description
- Patients will brush with the fluoride for 2 minutes each day.
- interventionNames
- Other: Brush
Primary outcomes (4)
- measure
- Fluoride use compliance
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available