A Randomised Controlled Trial to Compare Post-operative Sensitivity of Restorations Completed With Fill-Up, a Dual Curing Composite and Conventional Composite Resin
试验速览
- 阶段
- 不适用
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Post operative sensitivity
研究概览
简要总结
The trial compares patient-reported postoperative sensitivity of 2 existing dental filling materials. The dental filling materials will be used according to manufacturer's instructions and within the existing CE marked licence. We are interested in investigating which licensed material confers the least postoperative discomfort to our patients in normal clinical use.
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
- 是
入选标准
- •Patient is over 18
- •Patient is under 70
- •Patient is capable of informed consent
- •The tooth responds to sensitivity testing ('vitality test' with an electric pulp tester)
- •The cavity is suitable for composite restoration
- •The patient prefers composite to amalgam.
- •The restoration required involves 2 or more surfaces of the tooth
排除标准
- •The tooth does not respond to an electric pulp test
- •The patient is suffering dental pain at the time of consent
- •The patient is currently taking long term analgesics
- •The patient is incapable of giving informed consent
- •The patient is a child under 18
- •The patient is unable to return the VAS assessment sheets at the appropriate time
- •The tooth to be filled is periodontally involved (grade 2 or grade 3 mobile)
研究组 & 干预措施
Fill-Up composite resin
In this arm of the study, participants will have the dental restoration completed with "FillUp" from Coltene, a composite resin a CE marked and licensed restorative material.
干预措施: Fill-Up composite resin (Device)
Conventional; composite
In this arm of the study, participants will have the dental restoration completed with a conventional composite resin using a CE marked and licensed restorative material.
干预措施: Fill-Up composite resin (Device)
结局指标
主要结局
Post operative sensitivity
时间窗: 1 month
patient assessment by VAS
次要结局
未报告次要终点
研究者
T Paul Hyde
Clinical Associate Professor
University of Leeds