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NCT05403125 Clinical Trial

SDF Application in Oral Cancer Patients to Prevent Dental Caries

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05403125
Other study ID # SDF PCRP
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date December 31, 2023

Study information
Verified date May 2022
Source Texas A & M University Baylor College Of Dentistry
Contact Amal Noureldin, DDS
Phone 214-828-8354
Email anoureldin@tamu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date December 31, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of Head and Neck cancer Exclusion Criteria: - Prognosis less than 1 year - Radiation field of treatment does not involve jaws

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• silver diamine fluoride, 38%
Topical application to all surfaces of the teeth
• Sodium fluoride gel, 5000 PPM
Gel applied after application of silver diamine fluoride and dispensed for home use

Locations
Country Name City State
United States Baylor College of Dentistry Dallas Texas

Sponsors (2)
Lead Sponsor Collaborator
Texas A & M University Baylor College Of Dentistry University of Washington

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dental Caries (DMFS) Dental Caries Surfaces determined by intraoral inspection 6 months
Secondary Gingival Index Silness and Loe Gingival Index for assessment of gingival condition (0 to 3) determined clinically 6 months
Secondary Bleeding Index Bleeding at 6 sites of each tooth determined clinically 6 months
Secondary Oral Health Quality of Life Questionnaire 6 months
Secondary MD Anderson Symptom Inventory-Head and Neck Questionnaire 6 months
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