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临床试验/NCT06027528
NCT06027528已完成不适用

Evaluation of Socket Preservation Using Autogenous Dentine Graft With Or Without Autologous Fibrin Glue: 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: 2023年9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
入组人数
20
试验地点
1
主要终点
Change in buccolingual alveolar ridge width dimensions immediately after tooth extraction (baseline) and ≥ 6 months after (follow-up).

研究概览

简要总结

  • The aim of this interventional study is to investigate the dimensional changes in buccolingual alveolar ridge width in socket preservation using sticky dentin vs dentin graft alone
  • The main question: is dentin graft mixed with autologous fibrin glue has better dimensional changes than using dentin graft alone ?
  • outcomes: Change in buccolingual alveolar ridge width as well as apico-coronal alveolar ridge height

详细描述

  • Aim of the study: The aim of this study is to investigate the dimensional changes in buccolingual alveolar ridge width. As well as the apico-coronal alveolar ridge height following tooth extraction when using sticky grafts combined with demineralized dentin grafts for socket preservation.
  • Research Procedure in brief:

This study will be carried out on patients enrolled from the Outpatient Clinic of Oral Medicine and Periodontology department, Faculty of Dentistry, Cairo University. *operative procedure: Before tooth extraction, probing depths (PD), gingival recession (GR), and bleeding on probing (BOP) will be assessed at six sites (mid-facial, mesio-facial, disto-facial, mid-palatal, mesio-palatal, and disto-palatal) around the tooth to be extracted and on the adjacent teeth to verify their periodontal status. Local anesthesia will be administered by infiltration to achieve the necessary anesthesia to allow extraction of the indicated tooth. Flapless atraumatic extraction will be done. Extracted teeth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries or restorations (if present), using a high-speed stone. The pulp chamber will be cleaned with sterile endodontic files. Then, teeth will be grinded to fine particles.

The particles prepared will be immersed tooth in alcohol for 10 min for disinfection, then washed twice in saline and dried using sterile gauze.

Then the dentine graft particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralization then washed twice in saline and dried with sterile gauze

Then the patient will be randomly assigned to one of the treatment groups:

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)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Systemically healthy patients ≥18 years old
  • Nonsmoker
  • Teeth with root fracture, teeth with failed endodontic therapy or advanced caries
  • Intact extraction socket with no dehiscence or fenestration.

排除标准

  • Patients with systemic diseases.
  • Patients with dehiscence or fenestrations
  • Patients with presence or history of osteonecrosis of the jaws, with use of bisphosphonates, exposure to head and neck radiation, chemotherapy.
  • Patients with large distinct pre-apical pathology
  • Smokers of more than 10 cigarettes a day or equivalent to cigarettes
  • Breastfeeding or pregnant women
  • Patients without availability to attend follow-up visits or patients rejecting to sign the informed consent.

研究组 & 干预措施

dentin graft mixed with autologous fibrin glue

Experimental

extracted tooth will be grinded into small particles to form dentin graft that will be mixed with autologous fibrin glue to be grafted in the extracted socket

干预措施: dentin graft mixed with autologous fibrin glue (Procedure)

dentin graft

Active Comparator

extracted tooth will be grafted in the extracted socket

干预措施: dentin graft (Procedure)

结局指标

主要结局

Change in buccolingual alveolar ridge width dimensions immediately after tooth extraction (baseline) and ≥ 6 months after (follow-up).

时间窗: 6 month

superimposition of the 2 CBCT and using Scans which will be exported as DICOM format to 3D viewer software

次要结局

  • changes in apico-coronal alveolar ridge height immediately after tooth extraction and 6 months after(6 months)

研究者

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

Islam Mohamed Sherif

Teaching assistant in periodontology department

Cairo University

研究点 (1)

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