Long-term Clinical Evaluation of Composite Restoration Using Two-steps Universal Adhesive in Non-carious Cervical Lesion: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- sensitivity (modified USPHS)
研究概览
简要总结
The goal of this clinical study is to compare the clinical performance of a new 2-steps universal adhesive in patients with non-carious cervical lesions. The main question it aims to answer is: Is there any difference in clinical performance of a new 2-steps universal adhesives bonded with different etching strategies.
Participants will have restorations using a new 2-steps universal adhesives in different etching strategies.
- etch-and-rinse
- selective enamel etching
- self-etch
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Available for follow-up visits
- •Have at least 28 teeth/ 20 teeth under occlusion
- •Have at least 3 non-carious cervical lesions without peri-apical lesion. The lesion is not nearly exposed pulp and no history of previous restoration.
排除标准
- •Rampant / uncontrolled caries
- •Advanced untreated periodontal disease
- •>2 cigarette packs/day
- •Systemic or local disorders that could not undergo dental procedures
- •Xerostomia
- •Severe bruxism, clenching, TMD
- •Pregnancy at the time of screening
- •Known history of sensitivity to resin or related materials
- •Fixed orthodontic appliance or planning to have orthodontic treatment within 3 years
结局指标
主要结局
sensitivity (modified USPHS)
时间窗: 3 years
tooth sensitivity to hot/cold water, tactile
secondary caries (modified USPHS)
时间窗: 3 years
caries recurrent rate after restoration
retention (modified USPHS)
时间窗: 3 years
retention rate of the restoration that retain in the mouth after treatment
次要结局
- marginal adaptation (modified USPHS)(3 years)
研究者
Pipop Saikaew
Asst. Prof. Pipop Saikaew
Mahidol University