"Re-instrumentation vs Flap Surgery in Residual Pockets: a RCT on Clinical Efficacy"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- PD change
研究概览
简要总结
There are no studies comparing reinstrumentation and flap surgery for the treatment of residual periodontal pockets.
The aim of this RCT is to compare the re-instrumentation vs the flap surgery in terms of PD reduction, CAL gain, gingival recession, need of an additional surgery and pocket closure. Moreover, PROMs will be evaluated
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18aa
- •Patients with periodontal disease
- •Less than 20 cigarettes/day
- •No systemic antibiotic therapy in the last 3 months
- •At least one interdental site showing PD≥5mm after the non surgical periodontal initial therapy. Infrabony component of the defect ≤3mm at x-ray
- •Full-mouth plaque score and full-mouth bleeding score <15% at baseline (re-evaluation) measured at six sites per tooth
- •No previous periodontal surgery at the experimental tooth
排除标准
- •Connective tissue diseases
- •Pregnancy or lactating
- •Furcation involvement
- •Crowned tooth
- •Severe tooth mobility (class III)
- •Radiographical horizontal bone resorption exceeding the 50% of the root
研究组 & 干预措施
Non surgical re-instrumentation
The sites showing remaining pockets (PD>4mm), in the sextants allocated to re-instrumentation group, will be treated with subgingival debridement. The subgingival debridement will be performed after the administration of local oral anaesthesia (Articaine 1:100000) using a periodontal tip on ultrasonic instrument (EMS) and Gracey's curettes.
干预措施: Non surgical re-instrumentation (Procedure)
Flap surgery
All the sites showing a residual pocket in a sextant allocated to surgery group will receive flap surgery. After the administration of oral local anaesthesia (Articaine 1:100000) an intrasulcular flap will be raised. In order to preserve interdental tissue the flaps will be designed accordingly the principles of papillary preservation flap. Toot root will be carefully debrided using both ultrasonic instruments and Grecey's curettes. Bone recontouring and ostectomy/osteoplasty will be avoided. Single simple sutures will be used to close the flap (Vicryl 5-0).
干预措施: Flap surgery (Procedure)
结局指标
主要结局
PD change
时间窗: 12 months after the procedure
change in periodontal probing depth (in mm)
PD change
时间窗: 3 months after the procedure
change in periodontal probing depth (in mm)
PD change
时间窗: 6 months after the procedure
change in periodontal probing depth (in mm)
次要结局
- CAL change(12 months after the procedure)
- CAL change(3 months after the procedure)
- CAL change(6 months after the procedure)
研究者
Luigi Barbato
Clinical professor and principal investigator
University of Florence