A Comparison of Long-Term Effectiveness of Two Desensitizing Products: A Randomized Clinical Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The effectiveness of desensitizers through long-term period
研究概览
简要总结
This randomized, controlled, clinical trial aimed to compare the 6- month clinical performance of a desensitizer that contains calcium phosphate TM with a two-step self-etch adhesive SE and placebo (distilled water). At least 150 teeth wil be treated with desensitizing products and placebo randomly one third usig TM, one third using SE and one third using placebo. The efficiency of the materials will be evaluated at baseline, 1 week, 1 month, 3 months and 6 months after treatment.
详细描述
The aim of this randomized, controlled, clinical trial is to compare the clinical efficacy of a desensitizer that contains calcium phosphate with a two-step self-etch adhesive and placebo through a long-term period (6 months). At least fifty patients with a sensitivity score of 6 or higher, according to the Visual Analog Scale (VAS), with at least three teeth will participate in this study. Teethmate Desensitizer (TM), Clearfil SE Bond 2 (SE) and placebo (distilled water) will be applied randomly to three teeth of each patient. Recalls will be done at baseline, 1 week, 1 month, 3 months and 6 months after treatment by applying air-blast and the sensitivity scores will be determined according to VAS. The efficiency of the materials will be determined according to the VAS scores. Data will be analyzed using Paired t test and repeated measures of ANOVA.
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, Investigator)
盲法说明
The subjects will blind to the agent being used. At each recall the investigator used blank sheets with patients' names only to avoid bias relative to previous assessments
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
- 是
入选标准
- •Subjects with 3 or more hypersensitive teeth with a VAS (Visual Analog Scale) score
- •Willingness to participate in the study
排除标准
- •Subjects are unwilling to participate voluntarily
- •Patients under 18 years old
- •Those that were taking analgesic medicaments
- •Pregnant and breastfeeding females
- •The presence of a systemic disease that affects the participation
- •Teeth with cervical loss of hard tissue that need restoration absolutely
- •Large/defective restoration, caries or enamel cracks in sensitive teeth
- •Teeth with vulnerability to hypersensitivity after root scaling
- •Pulpitis presence.
研究组 & 干预措施
Clearfil SE Bond 2 (SE)
Two-step self etch adhesive resin treating dentin hypersensitivity b covering a film layer after light-curing.
干预措施: Clearfil SE Bond 2 (Other)
Teethmate Desensitizer (TM)
Calcium phosphate biomimetic material that forms hydroxyapatite from tetracalcium phosphate and dicalcium phosphate anhydrous and plug the dentin tubules causing remineralization and dentin hypersensitivity relief.
干预措施: Teethmate Desensitizer (TM) (Other)
Distilled water
Distilled water with no desensitizing components.
干预措施: Distilled water (Other)
结局指标
主要结局
The effectiveness of desensitizers through long-term period
时间窗: 6 months
The clinical efficacy of a desensitizer that contains calcium phosphate with a two-step self-etch adhesive and placebo through a long-term period. Evaluation will be performed usig the Visual Analog Scale(VAS). VAS values will be according to the following parameters: 0 - no discomfort;1 to 3 - light discomfort;4 to 6 - mild discomfort;7 to 9 - severe discomfort;10 - Unbearable discomfort. After each stimulus to the suspected site the degree of hypersensitivity will be determined from 6 to 10 as the preop VAS score for each individual painful tooth.
次要结局
- Subjective satisfaction of patients(6 months)
研究者
Leyla Kerimova
Principal Investigator
Baskent University