Laser in Caries Treatment - Patients´View, Pulpal Reactions and Survival of Fillings. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change of patients´ experience from baseline - 24 months
研究概览
简要总结
The aim of this study was to evaluate the excavation time, patients´ experiences, pulpal reactions and survival of fillings when carious tissue was removed with Er:YAG laser compared to rotary bur. A prospective, single-blind, randomized and controlled investigation was performed. Patients with at least two primary caries lesions radiographically assessed as the same size were recruited. In each patient one cavity was excavated with rotary bur and one with Er:YAG laser technique. The time requested for excavation and local anaesthesia were measured. The prevalence of postoperative symptoms, pulpal vitality and the quality of fillings will be investigated during two years after the excavation occasion.
详细描述
The study is a prospective, single-blind, randomized and controlled investigation. Patients between 15-40 years with at least two primary caries lesions radiographically assessed as the same size were recruited. In each patient one cavity was excavated with rotary bur and one with Er:YAG laser technique after a randomized allocation of the lesions to one of the intervention methods. The time requested for excavation to hard/firm dentin and local anaesthesia were measured. Directly after each treatment a questionnaire focusing on the experiences of the current treatment and if the laser method will be chosen in the future was answered. Postoperative pain was measured with a questionnaire one week after the treatment. Six, 12 and 24 months after the fillings were made an evaluation of pulpal status and the quality of the fillings will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor have not met the patient before assessing the outcome. No information about which excavation method used is available.
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients should be between 15 and 40 years,
- •at least two lesions with primary caries estimated as being of equal size, and needed to be treated, in bite-wing radiographs, and
- •comparable pairs of cavities should be located on either occlusal or approximal surfaces.
- •the lesions should not involve the inner third of the dentin.
排除标准
- •patients with severe general diseases ( ASA>2) (30),
- •cognitive or intellectual disabilities,
- •patients who required sedation or general anaesthesia, and
- •teeth with periapical pathology, a root filling or non-vital teeth.
研究组 & 干预措施
Er:YAG laser
Device Er:YAG laser
干预措施: Er:YAG laser (Device)
Rotary bur
Device rotary bur
干预措施: excavated with rotary bur (Device)
结局指标
主要结局
Change of patients´ experience from baseline - 24 months
时间窗: 0-24 months
questionnaire
次要结局
- Change of postoperative complications from baseline - 24 months(0-24 months)
- Survival of fillings(24 months)
研究者
Dr Pia Gabre
Professor
Public Dental Health in Uppsala Region