NCT05864989招募中不适用
Non-Incised Papilla Flap With and Without Connective Tissue Graft for Management of Deep Supraossous Defects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- interproximal clinical attachment level gain
研究概览
简要总结
The objective of this study was to assess the effectiveness of NIPSA in periodontal lesions with deep supra-alveolar defects, measuring the clinical efficacy of this flap. The non-incised papilla surgical approach (NIPSA) is a novel technique that accesses the periodontal defect from apical direction and was established with the aim of creating clinical advances compared with marginal access techniques.
The defects with a supra-alveolar components are more frequent than intrabony defects, there is very little evidence about their treatment .
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of periodontal disease (periodontitis stage III and IV, grade A [12];
- •non-smokers and former smokers who quit smoking at least 1 year previously
- •previous treatment for periodontal disease using non-surgical periodontal treatment completion of step I and II of periodontal therapy
- •compliance with periodontal maintenance and oral hygiene (FMPS at baseline ≤ 30%)
- •active residual pockets (positive bleeding on probing; BoP) associated with intrabony defects that were not resolved with non-surgical treatment after 4-6 months of maintenance.
- •periodontal lesions with probing depth (PD) > 6 mm and supraalveolar defect (pre-diagnosis clinically (periodontal probe)
排除标准
- •systemic disease contraindicating periodontal surgery,
- •smokers, and
- •third molars or teeth with incorrect
- •endodontic or restorative treatment.
结局指标
主要结局
interproximal clinical attachment level gain
时间窗: 6 MONTHS
measured from CEJ to base of pocket depth by using periodontal prob
次要结局
- residual pocket depth(6 MONTHS)
研究者
mahetab mohamed abdel el wahab
lecturer
Ain Shams University
研究点 (2)
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