NCT05403125

SDF Application in Oral Cancer Patients to Prevent Dental Caries

Silver Diamine Fluoride: Novel Addition to the Prophylactic Bundle for Dental Management of Radiation-Induced Dental Caries in Oral and Pharyngeal Cancer Patients

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Texas A & M University Baylor College Of Dentistry · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DEVICE	silver diamine fluoride, 38%	Topical application to all surfaces of the teeth
DEVICE	Sodium fluoride gel, 5000 PPM	Gel applied after application of silver diamine fluoride and dispensed for home use

Timeline

• Start date: 2022-05-20
• Primary completion: 2023-08-11
• Completion: 2025-03-18
• First posted: 2022-06-03
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study