Clinical Efficacy of Resin Based Coating Materials for Protecting Dental Root
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- treatment efficacy of the tooth: the change in VAS score before and after desensitization
研究概览
简要总结
The goal of this clinical trial is to learn if the adhesive Single Bond Universal works to treat dentin hypersensitivity in adults. It will also learn about the durability of Single Bond Universal. The main questions it aims to answer are:
Does Single Bond Universal has the function to treat dentin hypersensitivity in adults? Researchers will compare Single Bond Universal to a traditional desensitizer Hybrid Coat to see which one has higher efficiency and longer durability.
Participants will:
Receive the treatment of Single Bond Universal or Hybrid Coat at the first visit.
Visit the clinic at 1, 3, 6, 9, 12 months for follow-up evaluation. Reassess dentin sensitivity at each visit and record in terms of VAS score.
详细描述
This is a randomized, double-blind and controlled study to include 14 patients with dentin sensitivity. The study is a randomized controlled trial with split mouth control, with symmetrical tooth positions on both sides of the same patient as test and control groups, the test group being the group using the universal bonding agent and the control group being the group using the clinically used desensitizer (Hybrid Coat). 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, 6 months, 9 months and 12 months points after the desensitization treatment. Safety was assessed by evaluating appliance defects and adverse events at the same time 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged ≥ 18 years who were able to provide written informed consent.
- •Participants confirmed as healthy according to the examiner, without clinically significant diseases that could interfere with study outcomes.
- •Participants with symptoms of dentin hypersensitivity affecting symmetrical teeth on both sides due to gingival recession.
- •Symptomatic teeth without caries, filling materials, or use as abutments for removable partial dentures.
排除标准
- •Individuals with dentin hypersensitivity caused by other factors (e.g., erosion or wedge-shaped defects).
- •Individuals with teeth exhibiting deep periodontal pockets (≥ 4 mm) or with a difference in gingival recession between the two symptomatic teeth of ≥ 1 mm.
- •Individuals who had received treatment or used toothpaste for dentin hypersensitivity within the previous 4 weeks.
- •Individuals who had undergone tooth bleaching or periodontal treatment within the previous 4 weeks.
- •Individuals who had undergone cervical restorative treatment. Individuals who had taken nonsteroidal anti-inflammatory drugs or narcotic analgesics within the previous week.
结局指标
主要结局
treatment efficacy of the tooth: the change in VAS score before and after desensitization
时间窗: from enrollment to the last follow-up (12 months after treatment)
The severity of dentin sensitivity is assessed using visual analogue scale (VAS) with numbers 0-10 by participants after cold air 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
未报告次要终点