Post-operative Sensitivity and Clinical Performance of a Self-adhesive Restorative Material in Posterior Restorations.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- The post-operative sensitivity.
研究概览
简要总结
Adhesively restoring teeth using a resin-based composite and a modern dental adhesive is now considered a reliable, predictable, and durable procedure. However, adhering resin-based composite in conditions of suboptimal field control or complex cavity configurations remains challenging. In addition, the continuing discussions on the clinical use of dental amalgam and the feasibility of a phase out of the use of dental amalgam in the long term has become a central concern for restorative dentistry and has led to strong efforts to develop a substitute material for amalgam. With the goal of clinically shorter application times and lower technique sensitivity, the development of an advanced self-adhesive restorative tooth-colored restorative materials (ASAR) that no longer need pre-treatment with a separate adhesive have been under investigation. The aim of this study is to assess the post-operative sensitivity following restoration of teeth using a self-adhesive tooth-colored restorative material and to assess its clinical performance in comparison with conventional resin-based composite in posterior restorations
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
- Single (Participant)
盲法说明
All participants will be informed about the nature and objectives of the study; however, they will not be informed what material they would receive.
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
- •Patient is at least 18 years' old
- •Teeth are vital
- •Teeth are periodontal healthy
- •Tooth to be restored in normal occlusion with natural antagonist and adjacent teeth
- •Patient did not receive orthodontic treatment
- •Good level of oral hygiene.
排除标准
- •Non-vital or endodontically treated teeth
- •(Profound, chronic) periodontitis
- •Deep carious defects (close to pulp, < 1mm distance)
- •Heavy occlusal contacts or history of bruxism
- •Poor oral hygiene
- •Sustained dentin hypersensitivity
- •Taking anti-inflammatory, analgesic, or psychotropic drugs
研究组 & 干预措施
Bulk- Fill
Restorative procedure of the teeth will be performed using Filtek-Bulk Fill Posterior Restorative, Bulk-fill resin composite, (3M, ESPE) following application of an etch-and-rinse single bottle adhesive (3M, ESPE).
干预措施: Bulk-fill resin composite, (3M, ESPE) (Procedure)
Surefill One
Restorative procedure of the teeth will be performed using Surefil one™ Self-Adhesive Composite Hybrid (Dentsply, Sirona),
干预措施: Surefil one™ Self-Adhesive Composite Hybrid (Procedure)
结局指标
主要结局
The post-operative sensitivity.
时间窗: One month after the treatment.
For the evaluation of post-operative sensitivity, participants will be asked to record whether they experienced sensitivity using a 0-4 numerical rating scale (0 = none, 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe). The patients will be asked to fill in the pain scale forms 24 hours after the restorative procedure and daily up to seven days, and at 2 weeks and 1 month intervals.
次要结局
- Clinical performance of the restorations(6 months and 1 year after the treatment.)
研究者
Ghada Maghaireh
Principal Investigator
King Abdullah University Hospital