SDF Application in Oral Cancer Patients to Prevent Dental Caries

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Dental Caries

Clinical Trial Details

NCT number	NCT05403125
Study type	Interventional
Source	Texas A & M University Baylor College Of Dentistry
Contact	Amal Noureldin, DDS
Phone	214-828-8354
Email	anoureldin@tamu.edu
Status	Not yet recruiting
Phase	N/A
Start date	June 1, 2022
Completion date	December 31, 2023

View Details

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