SDF Application in Oral Cancer Patients to Prevent Dental Caries

Sponsor

Texas A & M University Baylor College Of Dentistry (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05403125

Collaborator

University of Washington (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Device: silver diamine fluoride, 38% Device: Sodium fluoride gel, 5000 PPM	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Controlled Trial, Intention to TreatRandomized Controlled Trial, Intention to Treat

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Dental Caries (DMFS) [6 months]
Dental Caries Surfaces determined by intraoral inspection

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of Head and Neck cancer

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baylor College of Dentistry	Dallas	Texas	United States	75246

Sponsors and Collaborators

Texas A & M University Baylor College Of Dentistry
University of Washington

Investigators

Principal Investigator: Amal Noureldin, DDS, TAMU Baylor College of Dentistry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amal Noureldin, Clinical Associate Professor, Texas A & M University Baylor College Of Dentistry

ClinicalTrials.gov Identifier:

NCT05403125

Other Study ID Numbers:

SDF PCRP

First Posted:

Jun 3, 2022

Last Update Posted:

Jun 3, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Amal Noureldin, Clinical Associate Professor, Texas A & M University Baylor College Of Dentistry

Oral and Pharyngeal Cancer

Xerostomia

Silver diamine fluoride

Sodium fluoride gel 5000 PPM

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 3, 2022