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临床试验/NCT04444063
NCT04444063已完成不适用

Clinical and Radiographic Evaluation of the Non-Incised Papilla Surgical Approach With and Without Allograft Plus Platelet Rich Fibrin in Treatment of Intraosseous Defects in Stage III Periodontitis Patients: A Randomized-Controlled Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年3月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Clinical attachment level gain (CAL) clinical attachment level gain (CAL)

研究概览

简要总结

Several minimal invasive techniques have been proposed since the last decade aiming to enhance and provide adequate environment for periodontal regeneration. Harrel and Rees proposed minimally invasive surgery (MIS) in 1995 and minimal invasive surgical technique (MIST) that was introduced in 2007 and then further enforced with modified minimally invasive surgical technique (M-MIST) in 2009 . A new minimal invasive technique called Non-Incised Papilla Surgical Approach (NIPSA) was introduced in 2017. It is aims to maintain the marginal tissues integrity by placing horizontal or oblique incision apical to the defect approaching the defect through apical access.

详细描述

Intraosseous vertical defects are one of the consequences that could result from periodontitis, which are classified according to their architecture by the number of residual walls, defect width as well as topographic extension in relation to the tooth.

Conventional surgery done for regenerative purpose regarding vertical defects has been known to be affected by clot stability, it was reported in the literature that reduced clinical outcomes occurred when early wound failure and exposure of the treated area occurred. This led to the innovation of different minimally invasive flap techniques that aimed at reducing the surgical trauma, allowing blood clot stability, protecting the regenerating site, reducing patient discomfort postoperatively as well as minimizing surgical chair time Among these techniques are papilla preservation flaps and minimally invasive surgical approaches with papilla elevation or without papilla elevation . However, these techniques had in their design incisions related to the interdental papilla which would jeopardize and complicate the vascular integrity of the interdental tissues Non incised Papilla surgical approach is a new surgical technique introduced by Moreno Rodriguez in 2017 to maintain the marginal tissues and the papilla intact by placing a horizontal or oblique incision apical to the defect and approaching it through an apical access leaving the marginal tissues to act as a "dome " protecting the blood clot

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)

盲法说明

single blinded

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Stage III periodontitis patient having at least one tooth with two wall or combined two to three walled intraosseous defect more than or equal 3 mm deep (assessed by trans-gingival probing, radiographic examination) with clinical attachment level (CAL) more than or equal 5mm and pocket depth (PD) more than or equal 6 mm.
  • Defect not extending to a root furcation area.
  • Vital teeth
  • No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
  • No surgical periodontal therapy carried out in the past 6 months.
  • Able to sign an informed consent form.
  • Patients who are cooperative, motivated, and hygiene conscious.
  • Able to come for the follow up appointment's needed.

排除标准

  • Any systemic disease that contra-indicates periodontal surgery or may affect healing.
  • Pregnant females
  • Drug abusers

研究组 & 干预措施

NIPSA technique with Allograft plus PRF

Experimental

Non-incised papilla preservation technique to treat intraosseous bony defects with the addition of Allograft plus PRF

干预措施: Non-Incised Papilla Surgical Approach (Procedure)

NIPSA technique

Active Comparator

Non-incised papilla preservation technique to treat intraosseous bony defects without the addition of Allograft plus PRF

干预措施: Non-Incised Papilla Surgical Approach (Procedure)

结局指标

主要结局

Clinical attachment level gain (CAL) clinical attachment level gain (CAL)

时间窗: 12 months

measured with UNC periodontal probe in mm

次要结局

  • Radiographic defect fill(12 months)
  • Plaque index(12 months)
  • Post-surgical patient Satisfaction(12 months)
  • Gingival recession (GR)(12 months)
  • Pocket depth (PD)(12 months)
  • Gingival bleeding(T1 T2 (Surgical phase- 8 weeks) , T4 3- months post-surgical ,T5 6-months post-surgical ,T6 1- Year post-surgical)

研究者

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

Ahmed mohamed Ibrahim Elkady

Teaching Assistant

Cairo University

研究点 (1)

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