SDF Application in Oral Cancer Patients to Prevent Dental Caries

NCT ID: NCT05403125

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-20

Study Completion Date

2025-03-18

Brief Summary

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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

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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

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial, Intention to Treat
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Test and placebo drugs will be identical in appearance and labeled by the manufacturer as A and B. The biostatistician will generate an assignment list. Individual packets will be prepared, and the clinician will open the packet to determine which study drug to apply. The packets and the drug containers will be color coded to minimize error. In each case a second staff member will verify on site that the participant received the correct coded treatment. Blinding: Participants and the examiners will be blind to treatment.

Study Groups

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Package

Topical application of 38% silver diamine fluoride plus 5000 PPM fluoride gel 1 mo before and 1 and 3 months after radiation treatment

Group Type EXPERIMENTAL

silver diamine fluoride, 38%

Intervention Type DEVICE

Topical application to all surfaces of the teeth

Sodium fluoride gel, 5000 PPM

Intervention Type DEVICE

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

Gel Alone

Placebo application of silver diamine fluoride plus 5000 PPM fluoride gel 1 mo before and 1 and 3 months after radiation treatment

Group Type ACTIVE_COMPARATOR

Sodium fluoride gel, 5000 PPM

Intervention Type DEVICE

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

Interventions

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silver diamine fluoride, 38%

Topical application to all surfaces of the teeth

Intervention Type DEVICE

Sodium fluoride gel, 5000 PPM

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

Intervention Type DEVICE

Other Intervention Names

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Advantage Silver Dental Arrest Elevate FluoriMax 5000R

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Head and Neck cancer

Exclusion Criteria

* Prognosis less than 1 year
* Radiation field of treatment does not involve jaws
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role collaborator

Texas A & M University Baylor College Of Dentistry

OTHER

Sponsor Role lead

Responsible Party

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Amal Noureldin

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amal Noureldin, DDS

Role: PRINCIPAL_INVESTIGATOR

TAMU Baylor College of Dentistry

Locations

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Baylor College of Dentistry

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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SDF PCRP

Identifier Type: -

Identifier Source: org_study_id

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