Effect of Biomimetic Hydroxyapatite-Based Toothpaste and Mouthwash on Dental Sensitivity in Patients With Gingival Recession: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Dental Sensitivity Measured by the Schiff Air Index
研究概览
简要总结
This randomized controlled clinical trial evaluates the effectiveness of a biomimetic hydroxyapatite-based toothpaste and mouthwash in reducing dental sensitivity in patients with gingival recession. A total of 100 participants will be randomly assigned to two groups. The control group will receive Biorepair Total Protection toothpaste, and the trial group will receive Biorepair high-density mouthwash. Both products will be applied for 30 seconds. Dental sensitivity will be assessed before and after treatment using the Shiff Air Index and the Visual Analogue Scale (VAS).
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged between 18 and 70;
- •Subjects with gingival recession and tooth sensitivity;
- •Subjects who have agreed to give their free written informed consent to participate in the study.
排除标准
- •Male and female subjects who are not adults;
- •Subjects without gingival recessions;
- •Subjects without dental sensitivity;
- •Subjects with poor participation or insufficient motivation to participate in this study.
结局指标
主要结局
Change in Dental Sensitivity Measured by the Schiff Air Index
时间窗: T0 (baseline) and T1 (immediately post-treatment, same visit)
Variation in dental sensitivity scores assessed using the Schiff Air Index at baseline (T0) and after a 30-second application of either toothpaste or mouthwash (T1). The Schiff scale ranges from 0 (no response) to 3 (painful response to air stimulus), with higher scores indicating greater sensitivity.
Change in Dental Sensitivity Measured by the Schiff Air Index
时间窗: T0 (baseline) and T1 (immediately post-treatment, same visit)
Variation in dental sensitivity scores assessed using the Schiff Air Index at baseline (T0) and after a 30-second application of either toothpaste or mouthwash (T1). The Schiff scale ranges from 0 (no response) to 3 (painful response to air stimulus), with higher scores indicating greater sensitivity.
次要结局
- Change in Pain Perception Measured by the Visual Analogue Scale (VAS)(T0 (baseline) and T1 (immediately post-treatment, same visit))
- Change in Pain Perception Measured by the Visual Analogue Scale (VAS)(T0 (baseline) and T1 (immediately post-treatment, same visit))
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia