SDF Application in Oral Cancer Patients to Prevent Dental... | NCT05403125

Studies
SDF Application in Oral Cancer Patients to Prevent Dental Caries

NCT05403125

Sponsor

Texas A & M University Baylor College Of Dentistry

Status

Completed

Last Update Posted

Sep 17, 2025Actual

Enrollment

56Actual

Phase

Early Phase 1

Conditions

Dental Caries

Interventions

silver diamine fluoride, 38%
Sodium fluoride gel, 5000 PPM

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 20, 2022Actual

Primary Completion Date

Aug 11, 2023Actual

Completion Date

Mar 18, 2025Actual

First Submitted Date

May 30, 2022

First Submission Date that Met QC Criteria

May 30, 2022

First Posted Date

Jun 3, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2025

Last Update Posted Date

Sep 17, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Texas A & M University Baylor College Of DentistryOTHER

Collaborators

Name	Class
University of Washington	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
silver diamine fluoride, 38%	Device	Topical application to all surfaces of the teeth	Package

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Head and Neck cancer

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amal Noureldin, DDS	TAMU Baylor College of Dentistry	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baylor College of Dentistry		Dallas	Texas	75246	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003731	Dental Caries
D010610	Pharyngeal Neoplasms
D014987	Xerostomia

Ancestor Terms

ID	Term
D017001	Tooth Demineralization
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D010039	Otorhinolaryngologic Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Quadruple

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.

Who Masked

ParticipantCare ProviderInvestigatorOutcomes Assessor