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SDF Application in Oral Cancer Patients to Prevent Dental Caries

NCT05403125 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-09-17

No results posted yet for this study

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.

Conditions

  • Dental Caries

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Amal Noureldin, DDS · TAMU Baylor College of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-20
Primary Completion
2023-08-11
Completion
2025-03-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05403125 on ClinicalTrials.gov