Clinical Evaluation of Polycation-based New Dental Desensitizer on Dentin Hypersensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement of dentin sensitivity induced by probe pressure stimulation
研究概览
简要总结
Evaluate the safety and clinical efficacy of new dental desensitizers in the treatment of dentin sensitivity, including the relief of sensitivity symptoms and the duration of efficacy.
详细描述
This is a randomized, single-blind and controlled study to include 40 patients with dentin sensitivity. The study will be a randomized controlled trial with split mouth control, with two quadrants of the same patient as test and control groups, the test group being the group using the new desensitizer and the control group being the group with the clinically used desensitizer (Gruma desensitizer). Improvement in dentin sensitivity symptoms was the primary outcome indicator observed. Dentin sensitivity was assessed by evaluating the reduction in dentin sensitivity VAS scores at immediately, 1 month, 3 months, and 6 months points after the desensitization treatment, and by evaluating the subjects' self-reported relief of sensitivity. Safety was assessed by evaluating appliance defects and adverse events at the immediately,1-, 3-, and 6-months points after the desensitization 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)
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
- •Dentin Hypersensitivity, with Vas score≥4 points and the normal pulp viability
- •dentin-sensitive tooth in at least 2 different quadrants of the mouth (neck enamel dentin exposure or maxillofacial abrasion within the middle layer of dentin).
- •in good overall health
- •participants informed consent.
排除标准
- •gastroesophageal reflux
- •Dental caries, wedge defects, crowns or large fillings.
- •Received dentin sensitivity desensitization treatment or used desensitization mouthwash within 1 month.
- •Received systematic periodontal therapy or periodontal surgery within 3 months, ongoing orthodontic treatment, and medical treatment, including long-term use of anti-inflammatory, analgesic, and psychotropic medications.
- •Pregnancy or breastfeeding.
- •Participated in other clinical trials in the past 3 months.
研究组 & 干预措施
Polycation-based new dentinal desensitizer
Use a cotton ball or brush to apply a small amount of desensitizing agent to the sensitive tooth surface for about 1 minute and wait for 2 minutes. Excess gel is then wiped off the surface.
干预措施: Polycation-based new dentinal desensitizer (Device)
GLUMA desensitizer
Use according to instructions
干预措施: GLUMA desensitizer (Device)
结局指标
主要结局
Improvement of dentin sensitivity induced by probe pressure stimulation
时间窗: At Baseline and 10 minutes, 1 month, 3 months, 6 months after desensitization treatment
The severity of dentin sensitivity is assessed using visual analogue scale (VAS) with numbers 0-10 by participants after probe pressure stimulation. Beforehand, the participants were informed that the 10 cm VAS would be used to assess their pain sensitivity, with 0 indicating no pain and 10 indicating the worst pain. Lower scores on the VAS indicate lower sensitivity. Dentin sensitivity was considered to have improved if the visual pain scale (F-VAS) score decreased by 2 or more points from baseline.
次要结局
- Improvement of dentin sensitivity induced by air temperature stimulation(At Baseline and 10 minutes, 1 month, 3 months, 6 months after desensitization treatment)