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临床试验/NCT04824235
NCT04824235已完成不适用

Alveolar Ridge Preservation Using Amniotic Chorion Membrane Alone or Combined With Xenograft (A Randomized Controlled Clinical Trial With Histological Evaluation)

Hams Hamed Abdelrahman1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年12月1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
发起方
入组人数
20
试验地点
1
主要终点
Change in Bucco-lingual bone width

研究概览

简要总结

the present study is to compare the amniotic chorion membrane (ACM) alone versus the amniotic chorion membrane combined with xenograft for their efficacy in alveolar ridge preservation procedures regarding volumetric changes assessed by cone beam computed tomography (CBCT).

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 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients require extraction of a non-restorable (premolar or anterior tooth) located in the maxillary arch and needs implant restoration.
  • Type two sockets will be selected as revealed by Cone beam computed tomography(CBCT)
  • Absence of any systemic disease or drugs that contraindicate oral surgery using Modified Cornell Medical Index
  • Male and female within age range of 20-45 years.

排除标准

  • Patients with poor oral hygiene or non-compliant patients who are not willing to perform oral hygiene measures.
  • Pregnant and breast-feeding females.
  • Patients with acute peri-apical infection or sinus tract.
  • Vulnerable group of patients as handicapped patients, orphans,prisoners,etc

研究组 & 干预措施

Amnoitic Chorion Membrane and xenograft

Experimental

extraction sockets where ridge preservation will be performed using Chorion Membrane with Xenograft

干预措施: Amniotic Chorion Membrane and Bio-Oss xenograft (Other)

Amnoitic Chorion Membrane only

Active Comparator

extraction sockets where ridge preservation will be performed using Chorion Membrane Alone

干预措施: Amniotic Chorion Membrane only (Other)

结局指标

主要结局

Change in Bucco-lingual bone width

时间窗: at baseline, 1 months and 4 months

Bone width will be measured using bone caliper and radiographically

total bone volume change

时间窗: at baseline, and 4 months

It will be evaluated by the use of 3D scans of patient dental models

Change in Corono-apical bone height

时间窗: at baseline, 1 months and 4 months

Bone height using a pre-fabricated stent.

次要结局

未报告次要终点

研究者

发起方
Hams Hamed Abdelrahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Alexandria University

研究点 (1)

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