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临床试验/NCT05445102
NCT05445102Unknown3 期

Clinical and Radiographic Effect of Extracted Autogenous Demineralized Dentin as a Bone Graft Substitute in Management of Periodontal Intrabony Defects: A Case Series

Cairo University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年5月22日最近更新:
适应症

试验速览

阶段
3 期
入组人数
10
试验地点
1
主要终点
Clinical attachment level gain

研究概览

简要总结

one of the ultimate goals in periodontology is to achieve periodontal regeneration and change the prognosis of questionable or hopeless teeth to maintainable.Bone substitutes have been actively used to reconstruct bony defects. Four categories of bone graft materials exist: Autograft, Allograft, Alloplast, and Xenograft.many researchers paid attention to human tooth as one of the intraoral donor sites due to the chemical and structural similarity between dentin and alveolar bone since both demonstrate low crystalline hydroxyl appetite (HA) with comparable calcium-to-phosphorus ratio.

Extracted tooth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present), using a high-speed fine finishing stone and saline irrigation. The pulp chamber will be cleaned with sterile endodontic files. Subsequently, teeth will be grounded, using hand bone mill .

ADDG particles prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralized then washed twice in saline and dried with sterile gauze. The intrabony defect will be debrided using hand and ultrasonic devices and then ADDG particles will fill the defect. Vertical or horizontal mattress sutures and additional interrupted single sutures will be performed to obtain primary closure of the interdental space. The selection of the suturing technique will be based upon the dimension of the interdental space and the thickness and height of the interdental tissues using 5-0 proline suture then follow up period at 3 months and 6 months measuring CAL which is primary outcome and radiographic bone fill , probing depth and recession which are secondary outcome.

研究设计

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

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

  • Patient-related criteria:
  • Motivated patient 18 years of age or order.
  • Patient consulting in the outpatient clinic.
  • Patient ready to perform oral hygiene instructions.
  • Provide informed consent.
  • Accepts the 6 months follow-up period.
  • Teeth related criteria:
  • Tooth with one or two walled intra-bony defect, probing depth ≥ 5mm with intra osseous defect ≥ 3mm.
  • Mature permanent tooth.
  • Unrestorable tooth or fractured tooth beyond restoration, impacted third molar or Supernumerary tooth to be extracted and used as whole tooth graft inside the defect

排除标准

  • Patient-related criteria:
  • Medically compromised patients.
  • Pregnant women.
  • Uncooperative patients.
  • Systemic diseases that may compromise healing or bone metabolism (e.g diabetes, hyperthyroidism)
  • Teeth related criteria:
  • Teeth with supra-bony defects.
  • Teeth with grade III mobility.

结局指标

主要结局

Clinical attachment level gain

时间窗: change from baseline at 3 month and change from baseline at 6 month

measured by william's periodontal probe

次要结局

  • Recession(change from baseline at 3 month and at 6 month)
  • Probing depth(change from baseline at 3 month and at 6 month)
  • Radiographic bone fill(change from baseline at 3 month and at 6 month)

研究者

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

Omnia Mohamed Shehata Abde Elmonaem

principal investigator

Cairo University

研究点 (1)

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