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NCT Number: NCT05403125

SDF Application in Oral Cancer Patients to Prevent Dental Caries

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.

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Key information

Conditions

Dental Caries Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Salivary Gland Diseases Stomatognathic Diseases Tooth Demineralization Tooth Diseases Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Baylor College of Dentistry

Dallas, Texas, 75246, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Head and Neck cancer

Exclusion criteria

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

Treatment and study plan

silver diamine fluoride, 38%

Device

Topical application to all surfaces of the teeth

Other names: Advantage Silver Dental Arrest

Sodium fluoride gel, 5000 PPM

Device

Gel applied after application of silver diamine fluoride and dispensed for home use

Other names: Elevate FluoriMax 5000R

Primary outcomes

  1. Dental Caries (DMFS)

    Time frame: 6 months

    Dental Caries Surfaces determined by intraoral inspection

Secondary outcomes

  1. Gingival Index

    Time frame: 6 months

    Silness and Loe Gingival Index for assessment of gingival condition (0 to 3) determined clinically

  2. Bleeding Index

    Time frame: 6 months

    Bleeding at 6 sites of each tooth determined clinically

  3. Oral Health Quality of Life

    Time frame: 6 months

    Questionnaire

  4. MD Anderson Symptom Inventory-Head and Neck

    Time frame: 6 months

    Questionnaire

Sponsors and collaborators

Lead sponsor

Texas A & M University Baylor College Of Dentistry

Other

Collaborators

  • University of Washington

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Jun 3, 2022
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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