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临床试验/CTRI/2019/10/021714
CTRI/2019/10/021714已完成4 期

Clinical, Histomorphometric and 3-Dimensional Cone Beam Computed Tomographic Analysis of Autogenous Tooth Bone Graft Mixed with Injectable Platelet Rich Fibrin for Ridge Preservation

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2019年12月16日最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
42
试验地点
1
主要终点
Postextraction dimensional and histologic changes in grafted sockets

研究概览

简要总结

Replacement of missing or extracted teeth by implants in anatomically, aesthetically, and long term functional restorative positions depend on having adequate bone and soft tissue dimensions both vertically and horizontally. Tooth extraction produces resorption and remodelling of socket dimensions which reduce bone volume available for implant placement subsequently. Even immediate placement of implant into socket sites will not prevent the loss of hard tissue dimension inside the socket wall.

Socket grafting to minimize the volume changes of socket i.e. Socket or Ridge Preservation has been reported with a number of filler materials being used, including allografts, xenografts, alloplasts, and bioactive materials such as bone morphogenetic proteins and platelet rich fibrin. Use of autologous tooth graft has gained wide popularity in last few years and has demonstrated bone regeneration in histomorphometric studies. Among the platelet derived products, injectable Platelet-rich Fibrin (iPRF) offers the characteristics of advanced PRF as a liquid. It contains high quantities of growth factors which stimulates cell proliferation and up-regulates angiogenesis. When injectable PRF is injected onto the bone graft, it gets adsorbed on the graft particles to form a cohesive mass. It may be hypothesized that a mixture of autogenous tooth bone graft and bioactive material (iPRF) may results in an increased percentage of vital bone formation.

Furthermore, the quality of augmented bone in extraction socket is the determinant of primary implant stability during implant placement and a critical factor in determining the success of dental implants. To date there is no research which has evaluated the quality of bone formation in extraction sockets grafted with ATBG mixed with iPRF and its clinical correlation with the primary implant stability. Therefore, aim of the present study is to evaluate the clinical, radiographic, and histomorphometric analysis of autogenous tooth bone graft mixed with injectable platelet rich fibrin for ridge preservation.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • b)Patients who have a clinically determined need for extraction of single rooted non-molar tooth (root or crown fractures, non-restorable caries and residual roots).
  • followed by an implant supported restoration c)Patients who will be available for further follow up.
  • d)Adequate restorative space for implant-supported restoration e)Presence of at least one tooth on each side to the tooth to be extracted.
  • f) ≥ 10-mm distance of alveolar bone crest from the base of the socket.
  • g)Root location and angulation that would be consistent with the subsequent implant placement.

排除标准

  • a)Inability or anticipated failure to maintain adequate oral hygiene b)Pregnant or lactating moth¬ers c) Patients with other systemic conditions (uncontrolled diabetes, unstable bleeding disorders, active infectious diseases; hepatitis, tuberculosis, HIV etc.) that could affect the healing ability of wound.
  • d)Mental disabilities that may hinder participation.
  • e)Active immunosuppressive therapy, cancer therapy and/or radiation to the oral cavity within the past 6 months f)Patients with acute dental infection of bone and ankylosed teeth.
  • g)Conditions/medications contraindicated for bone regeneration (e.g. methotraxate, cyclosporine A, steroids, bisphosphonates).
  • h)Multirooted teeth because of the potential for presence of interradicular bone that might be harvested as part of the core biopsy procedure.
  • i)Loss of more than 50% of buccal plate at the time of extraction.

结局指标

主要结局

Postextraction dimensional and histologic changes in grafted sockets

时间窗: 4 months

次要结局

  • Maximum insertion torque value during implant placement and radiographic bone density(4 months)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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