Randomized Controlled Trial to Evaluate the Efficacy of Er:YAG Laser and Surgical Therapy in Treatment of Chronic Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Probing pocket depth, Clinical attachment level and microbiological analysis
研究概览
简要总结
Conventional non-surgical periodontal treatment, that is, root debridement using manual and ultrasonic means at baseline and surgery using the same means after 6 months in case of persistent deep pockets (Group 1)/ Er:YAG laser used in a non-surgical approach at baseline and surgery using the same laser after 6 months in case of persistent deep pockets (Group 2)/ Surgery at baseline using manual and ultrasonic means (Group 3). All patients will undergo supragingival maintenance on a yearly basis.
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)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 35 years of age
- •at least 18 teeth present that can be retained by means of therapy among which 4 multirooted teeth or more(wisdom teeth excluded)
- •presence of at least one deep pocket per quadrant (6 mm PPD or more) with radiographic evidence of bone loss (>= 30% of root length)
排除标准
- •pregnancy
- •removable prosthesis
研究组 & 干预措施
1
Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using Er:YAG laser
干预措施: Er: YAG Laser (Procedure)
2
Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using conventional methods (ultrasonic and manual means)
干预措施: Conventional treatment 1(ultrasonic and manual means) (Procedure)
3
Surgery at baseline for all deep pockets using conventional methods (ultrasonic and manual means)
干预措施: Conventional treatment 2 (ultrasonic and manual means) (Procedure)
结局指标
主要结局
Probing pocket depth, Clinical attachment level and microbiological analysis
时间窗: At baseline, 3, 6, 12, 24, 36, 48 and 60 months
次要结局
- Gingivitis index, plaque index, bleeding on probing at the same time intervals + the number of interventions(After 5 years)
- Adverse effects described by the patient (number of painkillers taken, visual analogue scale to monitor post-operative pain, tooth sensitivity)(After 5 years)
- Consumed time per treatment/ Patient satisfaction/comfort ( Oral Health impact Profile : OHIP )/ The estimated financial costs based on average data delivered for instance by the Belgian Society of Periodontology(After 5 years)