Effects of DIammine SIlver Fluoride Placed Over Cervical Lesions of Permanent Teeth to Reduce Tooth Sensitivity
试验速览
- 阶段
- 不适用
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Erythema
研究概览
简要总结
The purpose of the study is to confirm the clinical effectiveness and safety of topical diammine silver fluoride (DASF) as a tooth desensitizer in adulst by comparing it to the application of sterile water.
The study will be conducted in two different sites in Peru. Participantes will be 144 adults who will have at least one vital maxillary or mandibular cuspid or premolar with a cervical defect on the buccal surface and clinical hypersensitivity in response to air. Subjects will be randomly assigned to a topical application of DAS or sterile water.
The reduction of pain (sensitivity) using a 100 mm VAS, will be determined. Safety will be also determined by evaluating the gingival condition (erythema, white changes, ulceration, staining) before and ater the application of the products. The evaluation times will be 24 hours and 7 days.
详细描述
Specific Aim: The purpose of this study is to confirm the clinical effectiveness and safety of topical diammine silver fluoride (DASF) as a tooth desensitizer in adults by comparing it to the application of sterile water.
Design: This is a blinded, randomized clinical trial with two groups. The study will be 1 week in duration.
Study Sites: The study will be conducted in two different sites in Peru (Cayetano University and Universidad Andina del Cusco). Cayetano University is a major private university in South America. It is a recipient of Fogerty International Center funds from NIH and has a history of successful collaboration with US universities, including the University of Washington. Dr. Castillo, the principal investigator, received his training in orthodontics at the University of Washington and is familiar with US clinical trials procedures.
Subjects: Participants will be 144 adults (18 to 50 years). Males and females will be included. Each site (Cayetano and Cusco) will recruit 72 subjects.
Inclusion Criteria: To be included the subject must have at least one vital maxillary or mandibular cuspid or premolar with a cervical defect on the buccal surface and clinical hypersensitivity in response to air with a score not less than 15 on the VAS for pain (described below). The individual will have generally healthy gum tissue surrounding this tooth and no ulceration, and no leukoplakia (white changes) in this gingival tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be included the subject must have at least one vital maxillary or mandibular cuspid or premolar with a cervical defect on the buccal surface and clinical hypersensitivity in response to air with a score not less than 15 on the VAS for pain (described below).
- •The individual will have generally healthy gum tissue surrounding this tooth and no ulceration, and no leukoplakia (white changes) in this gingival tissue.
排除标准
- •Excluded will be subjects who are using any type of commercially available tooth desensitizer, have received a fluoride varnish treatment within the last month, or who are taking prescription medications of any kind, are taking aspirin or nonsteroidal anti-inflammatory drugs habitually, and women who are pregnant.
- •Individuals using smokeless tobacco will be excluded. Individuals with known sensitivity to silver or other heavy-metal ions will be excluded.
结局指标
主要结局
Erythema
时间窗: 1 week
Sensitivity
时间窗: 1 week
Gingival index
时间窗: 1 week
次要结局
- white changes(1 week)
- ulceration(1 week)
- staining(1 week)