Sodium fluoride gel, 5000 PPM for Dental Caries

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Baylor College of Dentistry, Dallas, TX
Dental Caries
Sodium fluoride gel, 5000 PPM - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 6 months

6 months
Bleeding Index
Dental Caries (DMFS)
Gingival Index
MD Anderson Symptom Inventory-Head and Neck
Oral Health Quality of Life

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Gel Alone
1 of 2
Package
1 of 2
Active Control
Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Sodium fluoride gel, 5000 PPM · No Placebo Group · N/A

PackageExperimental Group · 2 Interventions: silver diamine fluoride, 38%, Sodium fluoride gel, 5000 PPM · Intervention Types: Device, Device
Gel Alone
Device
ActiveComparator Group · 1 Intervention: Sodium fluoride gel, 5000 PPM · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Closest Location: Baylor College of Dentistry · Dallas, TX
Photo of Dallas 1Photo of Dallas 2Photo of Dallas 3
2003First Recorded Clinical Trial
1 TrialsResearching Dental Caries
2 CompletedClinical Trials

Who is running the clinical trial?

University of WashingtonOTHER
1,571 Previous Clinical Trials
1,567,936 Total Patients Enrolled
12 Trials studying Dental Caries
3,752 Patients Enrolled for Dental Caries
Texas A & M University Baylor College Of DentistryLead Sponsor
4 Previous Clinical Trials
154 Total Patients Enrolled
1 Trials studying Dental Caries
15 Patients Enrolled for Dental Caries
Amal Noureldin, DDSPrincipal InvestigatorTAMU Baylor College of Dentistry

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.