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临床试验/NCT05047887
NCT05047887已完成不适用

Comparison of Socket Preservation Using Socket Shield Technique With Autogenous Dentin Graft Versus Alloplast Graft Material (Clinical and Histological Study)

Hams Hamed Abdelrahman1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2020年12月28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
8
试验地点
1
主要终点
post opertaive edema

研究概览

简要总结

Alveolar bone resorption and labial bone plate reduction follow teeth extraction due to the deficiency of blood supply, derived from the loss of periodontal ligaments, and hence the socket shield technique with autogenous dentine was introduced to preserve the periodontal ligaments.

this study aim to evaluate of socket preservation using alloplast with socket shield versus Autogenous dentin graft with socket shield through radiographic analysis of alveolar bone dimension change and mean bone density in addition to histological and histomorphometric analysis for the quality of the formed bone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • One or more of non-restorable (fractured or decayed) tooth/teeth in the maxillary aesthetic regions (incisors, premolars) in both side
  • Intact labial periodontal tissues.
  • Ability to read and sign an informed consent form.

排除标准

  • A medical history that contraindicates oral surgical treatment (uncontrolled/untreated diabetes mellitus, immunocompromised status, radio/chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous amino-bisphosponates).
  • Untreated periodontal disease.
  • Vertical root fractures on the labial aspect.
  • Tooth /teeth with horizontal fractures below bone level.
  • Tooth /teeth with external or internal resorptions.

研究组 & 干预措施

Study group (in one side)

Experimental

Modified socket shield technique with autogenous dentin graft

干预措施: Modified socket shield technique with autogenous dentin graft material (in one side) (Procedure)

Control group (in contrlateral side)

Active Comparator

Modified socket shield technique with alloplast

干预措施: Modified socket shield technique with alloplast graft material (in contralateral side) (Procedure)

结局指标

主要结局

post opertaive edema

时间窗: after 7 days

This will be assessed in the 1st week postoperatively and measured as follows: None (no inflammation) Mild (intraoral swelling confined to the surgical field) Moderate (extraoral swelling in the surgical zone) Severe (extraoral swelling spreading beyond the surgical zone).

change in pain score

时间窗: 1 week and 3 months

it will be assessed using VAS It rates pain on a scale from 1-10, with 0 representing "no pain" and 10 "very much pain

Change in bone density

时间窗: at baseline and 3 months

it will be assessed using CBCT

Change in bone height

时间窗: at baseline and 3 months

it will be assessed using CBCT

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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