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临床试验/NCT05982353
NCT05982353已完成1 期

Effect of Using a Hemostatic Gelatin Sponge Versus a Dense Polytetrafluorethylene Membrane for Socket Sealing Following Immediate Implant Placement. A Randomized Clinical Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
20
试验地点
2
主要终点
reverse torque test

研究概览

简要总结

Digital panoramas will be made to assess the implant sites. The included patients are assigned to their respective groups randomly. After implant submerging in the study group 2 layers of hemostatic resorbable gelatin sponge is fixed in the implant site; while with the control group PTFE is fixed. After 3 weeks the PTFE was removed while the gelatin sponge should be resorbed. 3 months later the implants are to be assessed for stability and a reverse torque test was used to confirm osseointegration during uncovering.

Follow-up appointments at 1,3 weeks and 1,2 & 3 months were planned.

详细描述

Dental implants are considered the gold standard for treatment of edentulous spaces. Immediate implant placement has multiple advantages including the shorter treatment span, less surgical procedures and faster loading possibility [1]. One of the drawbacks of immediate implant placement is proper soft tissue coverage of the submerged implant to prevent socket infection and allow implant stability and osseointegration [2]. To overcome these issues the use of membranes has been the standard procedure [3].

Polytetrafluoroethylene membranes (PTFE) have been reported vastly in literature and their results and clinical effect on soft tissue healing and guided tissue regeneration (GTR) around implants and in surgical sites. Dense PTFE allows for GTR by only promoting non-bacterial migration and improving cellular adhesion which promotes tissue regeneration underneath it [4]. On the other hand, PTFE membranes are quite expensive and with the economic crisis the world is facing the use of other less expensive options is crucial. Gelatin sponges are vastly used as hemostatic agents in minor surgical procedures and have shown excellent results in terms of hemostasis and rapid resorption [5]. The application of such material are multiple; such as with sinus lift procedures [6], microvascular decompression[7] and as a wound dressing [8].

The investigators hereby propose the use of hemostatic gelatin sponges as membranes for submerged immediate implants as a simpler and cheaper alternative to PTFE.

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 (Participant)

盲法说明

blinded envelopes selected by operator

入排标准

年龄范围
22 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients with badly broken down tooth indicated for immediate implantation
  • generally healthy patients 22-50 years of age
  • non smokers
  • good oral hygiene

排除标准

  • poor bone quality
  • poor oral hygiene
  • non compliant patient

结局指标

主要结局

reverse torque test

时间窗: 3 months after implant placement

the implants will be subjected to a reverse torque test of 30 N/cm using a calibrated torque wrench. this should identify proper osseointegration.

次要结局

  • Clinical soft tissue healing(2,3 weeks and 3 months)

研究者

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

Alaa Emara

A.Professor OMFS

Cairo University

研究点 (2)

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