Dental Caries
Conditions
Keywords
Oral and Pharyngeal Cancer, Xerostomia, Silver diamine fluoride, Sodium fluoride gel 5000 PPM
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.
Interventions
DEVICEsilver diamine fluoride, 38%
Topical application to all surfaces of the teeth
DEVICESodium fluoride gel, 5000 PPM
Gel applied after application of silver diamine fluoride and dispensed for home use
Sponsors
University of Washington
Texas A & M University Baylor College Of Dentistry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention model description
Randomized Controlled Trial, Intention to Treat
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Head and Neck cancer
Exclusion criteria
* Prognosis less than 1 year * Radiation field of treatment does not involve jaws
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dental Caries (DMFS) | 6 months | Dental Caries Surfaces determined by intraoral inspection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed