SDF Application in Oral Cancer Patients to Prevent Dental Caries

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dental Caries

Intervention / Treatment
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* Device: silver diamine fluoride, 38%
* Device: Sodium fluoride gel, 5000 PPM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Head and Neck cancer Exclusion Criteria: Prognosis less than 1 year Radiation field of treatment does not involve jaws

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial, Intention to Treat
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Package<br>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%<br>* Topical application to all surfaces of the teeth<br>* Other names: Advantage Silver Dental Arrest;Device: Sodium fluoride gel, 5000 PPM<br>* Gel applied after application of silver diamine fluoride and dispensed for home use<br>* Other names: Elevate FluoriMax 5000R;|
| Active Comparator: Gel Alone<br>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<br>* Gel applied after application of silver diamine fluoride and dispensed for home use<br>* Other names: Elevate FluoriMax 5000R;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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 | 6 months | 
| Oral Health Quality of Life | Questionnaire | 6 months | 
| MD Anderson Symptom Inventory-Head and Neck | Questionnaire | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral and Pharyngeal Cancer, Xerostomia, Silver diamine fluoride, Sodium fluoride gel 5000 PPM