An Early Phase 1 interventional study of silver diamine fluoride, 38% and Sodium fluoride gel, 5000 PPM in Dental Caries, sponsored by Texas A & M University Baylor College Of Dentistry. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by Texas A & M University Baylor College Of Dentistry · Early Phase 1, Interventional, and Prevention
The Texas A \& M College of Dentistry, with partner Texas Oncology-Baylor Charles A. Sammons Cancer-Center Radiation-Oncology, proposes to conduct a preliminary clinical study (NIH Stage 0) to pilot test a randomized clinical trial of the efficacy of professionally applied 38% silver diamine fluoride to prevent tooth decay in 60 patients who are being treated with radiation for life threatening head and neck cancer.
Head and neck cancer has increased in Texas over the last two decades. Radiation-induced tooth decay is a devastating yet potentially preventable side effect of the cancer treatment. Silver diamine fluoride, already the standard of care in children, is inexpensive, easy to apply, and safe. The objective of the research is to conduct a single site pilot RCT (NIH Stage 0) to determine feasibility and preliminarily assess the efficacy of 38% silver diamine fluoride and 5000 PPM fluoride gel for prevention of radiation-induced dental caries over 6 months. Eligible participants will be up to 60 head and neck cancer patients who are scheduled for radiotherapy. The proposed intervention will be applied within 1 m before and at 1- and 3-m post radiation. The primary outcome is dental caries surfaces at 6 months post-radiotherapy (DMFS).Secondary outcomes are The Gingival Index, Gingival Bleeding Index, MDASI-HN, and Oral Health Quality of Life score will be secondary outcomes.
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
This study's enrollment of 56 is close to the median of 60 across 967 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Texas A & M University Baylor College Of Dentistry is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Topical application of 38% silver diamine fluoride plus 5000 PPM fluoride gel 1 mo before and 1 and 3 months after radiation treatment
Device: silver diamine fluoride, 38% · Device: Sodium fluoride gel, 5000 PPM
Placebo application of silver diamine fluoride plus 5000 PPM fluoride gel 1 mo before and 1 and 3 months after radiation treatment
Device: Sodium fluoride gel, 5000 PPM
Topical application to all surfaces of the teeth
Also known as: Advantage Silver Dental Arrest
Gel applied after application of silver diamine fluoride and dispensed for home use
Also known as: Elevate FluoriMax 5000R
Dental Caries (DMFS)
Dental Caries Surfaces determined by intraoral inspection
Time frame: 6 months
Gingival Index
Silness and Loe Gingival Index for assessment of gingival condition (0 to 3) determined clinically
Time frame: 6 months
Bleeding Index
Bleeding at 6 sites of each tooth determined clinically
Time frame: 6 months
Oral Health Quality of Life
Questionnaire
Time frame: 6 months
MD Anderson Symptom Inventory-Head and Neck
Questionnaire
Time frame: 6 months
Plan to share: No
Ran from May 2022 to primary completion in Aug 2023, 14 months.
Of 15 phase 1 interventional studies under Dental Caries, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 18. This study's 14 months is close to that.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Texas A & M University Baylor College Of Dentistry