Pain Control in Dentin Hypersensitivity in Patients With MIH: Study Protocol for a Randomized, Controlled, Clinical Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 140
- 主要终点
- Change in Pain Evaluated by a Visual Analog Scale (VAS)
研究概览
简要总结
This study aims to evaluate the effectiveness of different protocols in controlling dentin hypersensitivity in patients with teeth affected by MIH. The subjects will be randomly designated in four experimental groups, according to different treatments. Pain will be assessed with the visual analog scale (Visual Analogue Scale - VAS), after stimulation with air from the triple syringe and and an exploratory probe at the time of (initial) recruitment, immediately after treatment, after 1 week and 1 month, 3 and 6 months after treatment.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Study participants and the outcome assessor of sensitivity will be blind to the procedure. However, the researcher who will apply the products is not blind, due to the different forms of clinical manipulation of products.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be between 18 and 35 years old;
- •Present good general health;
- •Present at least one tooth with dentin hypersensitivity reported in the cervical region, which must have a graduated sensitivity equal to or greater than 4 in the VAS scale.
排除标准
- •Present active caries lesions or restoration defects in the tooth to be analyzed;
- •Present sufficient dentin loss that requires restorative treatment or periodontal surgery;
- •Volunteers who underwent any professional desensitizer treatment in the last 6 months;
- •Volunteers who used desensitizing pastes in the 3 months;
- •Volunteers who were using anti-inflammatory or analgesic drugs at the time of recruitment;
- •Volunteers who are pregnant or breastfeeding.
结局指标
主要结局
Change in Pain Evaluated by a Visual Analog Scale (VAS)
时间窗: Baseline, immediately after treatment, 1 week, 1, 3 and 6 months after treatment.
Pain will be assessed with the visual analogue scale (Visual Analogue Scale - VAS), after stimulation with air from the triple syringe and an explorer probe.
次要结局
未报告次要终点
研究者
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho