跳至主要内容
临床试验/NCT06003322
NCT06003322招募中不适用

Non - Incised Papilla Versus Single Flap Technique In The Reconstruction Of Intrabony Defect: a Randomized Controlled Trial

Ain Shams University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年8月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
interproximal clinical attachment level change

研究概览

简要总结

The present study will aim to assess the effectiveness of the non-Incised Papilla surgical approach NIPSA used for the surgical debridement of deep intraosseous defects compared to the single-flap approach SFA.

Primary outcome: interproximal clinical attachment level gain Secondary outcomes: residual probing pocket depth (PPD), pocket depth (PD) reduction, recession (REC), location of the tip of the papilla (TP), width of the keratinized tissue (KT), wound closure (WC), supra-alveolar attachment gain (SUPRA-AG)

详细描述

The present study will aim to assess the effectiveness of the non-Incised Papilla surgical approach NIPSA used for the surgical debridement of deep intraosseous defects compared to the single-flap approach SFA.

Primary outcome: interproximal clinical attachment level gain Secondary outcomes: residual probing pocket depth (PPD), pocket depth (PD) reduction, recession (REC), location of the tip of the papilla (TP), width of the keratinized tissue (KT), wound closure (WC), supra-alveolar attachment gain (SUPRA-AG)

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
Double (Care Provider, 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

入选标准

  • - Age > 18 years
  • Diagnosis with stage III-IV periodontitis.
  • Presence of one or more intrabony defects with probing pocket depth (PPD) > 5 mm and radiographic defect depth > 4 mm.
  • Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) < 30% (measured at four sites per tooth).
  • No relevant systemic condition or disease.

排除标准

  • Third molars and teeth with type III mobility or with an incorrect endodontic or restorative treatment.

结局指标

主要结局

interproximal clinical attachment level change

时间窗: at baseline ,6 and 12 months

CAL, measured in the interproximal space from the CEJ to the base of the pocket(BP)using a millimeter periodontal probe

次要结局

  • residual probing pocket depth (PPD), pocket depth (PD) change,(at at baseline ,6 and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Talaat Ali

lecturer

Ain Shams University

研究点 (2)

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