Silver Diamine Fluoride: Novel Addition to the Prophylactic Bundle for Dental Management of Radiation-Induced Dental Caries in Oral and Pharyngeal Cancer Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Dental Caries (DMFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Head and Neck cancer
排除标准
- •Prognosis less than 1 year
- •Radiation field of treatment does not involve jaws
结局指标
主要结局
Dental Caries (DMFS)
时间窗: 6 months
Dental Caries Surfaces determined by intraoral inspection
次要结局
- Bleeding Index(6 months)
- MD Anderson Symptom Inventory-Head and Neck(6 months)
- Gingival Index(6 months)
- Oral Health Quality of Life(6 months)
研究者
Amal Noureldin
Clinical Associate Professor
Texas A & M University Baylor College Of Dentistry