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临床试验/NCT05922527
NCT05922527已完成不适用

Clinical and Radiographic Evaluation of Using Amnion Chorion Membrane Combined With Allograft Bone Putty for the Management of Intrabony Defects in Patients With Chronic Periodontitis: a Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Clinical attachment level gain

研究概览

简要总结

The ultimate goal for periodontal management is to obtain true periodontal regeneration. Periodontal regeneration implies that CAL gain is achieved through the formation of new cementum and new inserted periodontal ligaments, accompanied by alveolar bone formation, thus a whole new periodontal apparatus is reconstructed. Combined periodontal regenerative therapy; including bone grafting are considered a viable treatment option and result in significantly better clinical outcomes in intrabony defects compared to monotherapy.

This study was conducted as a randomized controlled clinical trial to evaluate clinically and radiographically the possible predictable results regarding the use of amnion chorion allograft (ACM) barrier and demineralized freeze dried bone allograft, (DFDBA) versus open flap debridement (OFD) in treatment of periodontal intrabony defects.

详细描述

True periodontal regeneration is the ultimate goal for periodontal management, implies that clinical attachment level gain is achieved through the formation of new cementum and new inserted periodontal ligaments, accompanied by alveolar bone formation, thus a whole new periodontal apparatus is reconstructed. Various techniques and biomaterials have been used to achieve periodontal regeneration of intraosseous defects.

In order to compare the effectiveness of various periodontal regenerative therapies in treating periodontal infrabony defects many systematic reviews were carried out. The use of guided tissue regeneration (GTR) and the combined therapies as regenerative approaches were shown to be more effective than flap procedures, nonetheless, the differences between regenerative therapies to be minor and insignificant.

Amnion chorion placental derived membrane (ACM) has been introduced in periodontal regenerative therapy owing to its biological properties. It is biocompatible, biodegradable and promotes proliferation and migration of the adjacent autogenous connective tissue. There is no single reported incidence of graft rejection, disease transmission or immune response from using placental tissues since its first documented usage till today. ACM has been used in many surgical dental procedures as GTR, alveolar bone preservation and guided bone regeneration. ACM possesses unique features that make it different from other materials used in this fields. In periodontal regenerative procedures as GTR, ACM assists rapid epithelial cell growth instead of epithelial cells exclusion as for the traditional concept of GTR. As epithelial cells are encouraged to migrate rapidly across the ACM barrier, they form an epithelial seal over the underlying bone graft or bony defect space and do not apically migrate into the defect .

Several studies support the use of ACM as an effective material alternative to the currently used materials/techniques for periodontal regeneration procedures, however more well conducted studies are still needed.

Accordingly, numerous data and researches are available nowadays, which support the great and variant regenerative capacities of the different periodontal biomaterials that are widely available and currently used for treatment of periodontal intra-bony defects, especially DFDBA and ACM. However, minimal radiographic findings were mentioned in the previous systematic reviews comparing combined regenerative approach and OFD.

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 (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Mature permanent tooth.
  • Tooth with two or three-walled intra-bony defect, PPD ≥ 5mm with intra osseous defect ≥ 3mm.
  • Good oral hygiene.
  • Compliance with the maintenance program.
  • Accepted the 6 months follow-up period.

排除标准

  • Teeth with one wall intra-bony defect or supra-bony defects.
  • Teeth with grade II or III mobility.
  • Teeth with proximal carious defects or proximal faulty restorations.
  • Medically compromised patients.
  • Pregnant or nursing women.

结局指标

主要结局

Clinical attachment level gain

时间窗: 6 months

clinical attachment level gain intragroup and intergroup, measured clinically in mm using periodontal probe

次要结局

  • Bone defect area(6 months)
  • Probing Pocket Depth Change(6 months)

研究者

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

Mariam Samy Abdelmalak Hanna

Principle investigator

Cairo University

研究点 (1)

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