An Early Phase 1 interventional study of Fluoride varnish and Regular Care in Dental Diseases, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-03.
Sponsored by Wake Forest University Health Sciences · Early Phase 1, Interventional, and Prevention
Radiation therapy to treat cancer may cause a dry mouth from damage to salivary glands which may increase the risk of cavities on the teeth. The consistent use of prescription fluoride on teeth after radiation therapy for head and neck cancer may reduce the development of cavities and tooth loss. The purpose of this study is to find out if prescription fluoride varnish applied to the teeth every three months during the first year after radiation therapy changes the development of cavities or gum problems.
The overall objective of this clinical trial is to determine if oncology practices can reduce dental disease in head and neck cancer patients post radiation therapy. Participants will have fluoride varnish applied at planned oncology follow-up visits and medical oncology providers will be instructed on recognizing dental disease and referring head and neck cancer patients for dental care when needed.
80 studies on the registry are indexed under Stomatognathic Diseases; 14 are open to participants now.
This study's enrollment of 13 is below the median of 60 across 59 interventional studies indexed under Stomatognathic Diseases.
Browse Stomatognathic Diseases studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
OR
Diagnosed with a non-SCC, non-SGC of the head and neck region, and intends to receive RT, with or without concomitant chemotherapy. The participant must be expected to receive at least 4500 cGy to one of the following sites:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
head and neck cancer patients receive fluoride varnish applied to teeth and follow-up dental screening during regularly scheduled oncology appointments.
Drug: Fluoride varnish
control group consisting of head and neck cancer patients receiving regular care of no Intensive Preventative Dental Program.
Other: Regular Care
Medical Oncology care team members (MD, DO, PA, NP, RN) who participate in Intensive Preventative Dental Program.
Other: Medical Oncology Care Team
fluoride varnish placed on teeth by a trained healthcare provider at four visits three months apart
standard oncology assessment visit without Intensive Preventative Dental Program services
Medical Oncology care team members participating in the Intensive Preventative Dental Program will be guided on recognizing dental disease and when it is appropriate to refer head and neck cancer patients for dental care.
Change in Decayed, Missing and Filled Surfaces Score
Decayed, Missing and Filled Surfaces Score (DMFS) is calculated by a calibrated oral examiner as the combined number of of decayed, missing, and/or filled tooth surfaces, from the baseline dental visit DMFS score before starting radiotherapy to the final dental visit DMFS score 12 months following completion of radiation therapy.
Time frame: from baseline to 12 months
Rate of Tooth Loss
Number of teeth lost per participant as determined by a calculated oral examiner from the baseline dental visit before the start of radiotherapy to the dental visit 12 months after completing radiation therapy.
Time frame: from baseline to 12 months
Rate of Oral Hygiene Compliance
Number of participants who self-report daily toothbrushing and flossing from the baseline dental visit before the start of radiotherapy to the dental visit 12 months after completing radiation therapy.
Time frame: from baseline to 12 months
Rate of Fluoride Compliance
Number of participants who self-reported use of prescription fluoride daily from the baseline dental visit before the start of radiotherapy to the dental visit 12 months after completing radiation therapy.
Time frame: from baseline to 12 months
Rate of Routine/Preventative Dental Care
Number of participants who self-report visiting a dental office within the last six months from the baseline dental visit before the start of radiotherapy to the dental visit 12 months after completing radiation therapy.
Time frame: from baseline to 12 months
Medical Oncology Care Team Post-study Feasibility Survey
The feasibility survey evaluates the logistics and success in implementing the Intensive Preventative Dental Program for Medical Oncology Team Providers treating head and neck cancer patients by gathering feedback from the Medical Oncology Care Team. Items are scored with 1-5 point Likert scale with a lower scale indicating higher satisfaction with the intervention.
Time frame: 12 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — As this is a pilot study which forms the basis of a larger clinical trial, individual deidentified participant data will be shared upon reasonable request to the primary investigators, along with a data dictionary outlining variables collected and data collection forms when appropriate.
Supporting information: Informed consent form
Time frame: IPD will be available December 1, 2025 until at least December 1, 2030.
Access criteria: Individual deidentified participant data as outlined above will be shared upon reasonable request to the primary investigators until the conclusion of the follow-up study (approximately December 2030)
Ran from Oct 2021 to primary completion in Jul 2024, 32 months.
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Studies of the drug tested here: Sodium Fluoride
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