SDF Application in Oral Cancer Patients to Prevent Dental Caries

NCT05403125 | Completed Early Phase 1 FDA Device

• 1 other identifier: SDF PCRP
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Oral and Pharyngeal Cancer; Xerostomia; Silver diamine fluoride; Sodium fluoride gel 5000 PPM

Outcome Measures

Primary Outcomes (1)

• Dental Caries (DMFS)

  Dental Caries Surfaces determined by intraoral inspection

  6 months

Secondary Outcomes (4)

• Gingival Index

  6 months

• Bleeding Index

  6 months

• Oral Health Quality of Life

  6 months

• MD Anderson Symptom Inventory-Head and Neck

  6 months

Study Arms (2)

Package

EXPERIMENTAL

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%; Device: Sodium fluoride gel, 5000 PPM

Gel Alone

ACTIVE COMPARATOR

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

Interventions

silver diamine fluoride, 38% DEVICE

Topical application to all surfaces of the teeth

Also known as: Advantage Silver Dental Arrest

Package

Sodium fluoride gel, 5000 PPM DEVICE

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

Also known as: Elevate FluoriMax 5000R

Gel Alone; Package

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Head and Neck cancer

You may not qualify if:

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

Sponsors & Collaborators

• Texas A & M University Baylor College Of Dentistry: lead
• University of Washington: collaborator

Study Sites (1)

Baylor College of Dentistry

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Dental Caries; Pharyngeal Neoplasms; Xerostomia

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Salivary Gland Diseases; Mouth Diseases

Study Officials

• Amal Noureldin, DDS

  TAMU Baylor College of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Randomized Controlled Trial, Intention to Treat

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 3, 2022
• Study Start: May 20, 2022
• Primary Completion: August 11, 2023
• Study Completion: March 18, 2025
• Last Updated: September 17, 2025

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)