NCT05460988已完成不适用
"Re-instrumentation vs Flap Surgery in Residual Pockets: a RCT on Clinical Efficacy"
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 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
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)
次要结局
- CAL change(12 months after the procedure)
研究者
Luigi Barbato
Clinical professor and principal investigator
University of Florence
研究点 (2)
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