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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Device: silver diamine fluoride, 38%; Device: Sodium fluoride gel, 5000 PPM

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of Head and Neck cancer

Exclusion Criteria:

• Prognosis less than 1 year
• Radiation field of treatment does not involve jaws

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Package; 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%; Topical application to all surfaces of the teeth; Other Names: Advantage Silver Dental Arrest; Device: Sodium fluoride gel, 5000 PPM; Gel applied after application of silver diamine fluoride and dispensed for home use; Other Names: Elevate FluoriMax 5000R
Active Comparator: Gel Alone; 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; Gel applied after application of silver diamine fluoride and dispensed for home use; Other Names: Elevate FluoriMax 5000R

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental Caries (DMFS)	Dental Caries Surfaces determined by intraoral inspection	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival Index	Silness and Loe Gingival Index for assessment of gingival condition (0 to 3) determined clinically	6 months
Bleeding Index	Bleeding at 6 sites of each tooth determined clinically	6 months
Oral Health Quality of Life	Questionnaire	6 months
MD Anderson Symptom Inventory-Head and Neck	Questionnaire	6 months

Collaborators and Investigators

• Sponsor: Texas A & M University Baylor College Of Dentistry
• Collaborators: University of Washington
• Investigators: Principal Investigator: Amal Noureldin, DDS, TAMU Baylor College of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2022
• Primary Completion (Actual): August 11, 2023
• Study Completion (Actual): March 18, 2025

Study Registration Dates

• First Submitted: May 30, 2022
• First Submitted That Met QC Criteria: May 30, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Xerostomia; Oral and Pharyngeal Cancer; Silver diamine fluoride; Sodium fluoride gel 5000 PPM
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Tooth Diseases; Head and Neck Neoplasms; Otorhinolaryngologic Diseases; Salivary Gland Diseases; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Tooth Demineralization; Pharyngeal Neoplasms; Dental Caries; Xerostomia; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride
• Other Study ID Numbers: SDF PCRP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes