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Radiographic Assessment of Bone Regeneration in Alveolar Sockets With PLGA Scaffold

2009年2月3日 更新者:Bio-Scaffold International Pte Ltd

Phase I Radiographic Assessment of Bone Regeneration in Alveolar Sockets With PLGA Bioscaffold After Teeth Extraction

After extraction of a tooth, the bony socket heals naturally but due to the absent of the tooth and any presence of support in the socket, bone resorption occur both vertically and bucco lingually or bucco palataly. This bony resorption ultimately effects a lot of things like - the support for the adjacent teeth become weak, the shallow ridge makes it difficult for future prosthesis retention, and less bony support for any implant placement in the future which is the most popular and effective way of tooth replacement now a days. So now a days keeping the integrity and contour of the alveolar bony socket is very important for the patients future rehabilitation. The use of scaffold will help to maintain the integrity of the alveolar bony socket thus provides a vital support for the adjacent teeth, preserve the alveolar crest height, maintain the bony contour, helps to prevent bleeding, and most importantly it will help in bone regeneration which is the vital factor for future rehabilitation.

研究概览

详细说明

A case controlled study design is adopted. Patients who will be having extraction of any tooth including surgical extraction but not due to any periodontal reasons are selected. Consent of the patient will be taken for the procedure and all the effects and possibilities will be explained to the patients. Extraction will be done and scaffold material will be placed inside the socket. Sockets with the scaffold will be the variable studied and the sockets without scaffold placed inside the sockets will be the control group. An OPG x ray will be taken with the head position standardized by a positioning device. A second x-ray will be taken following the same technique after two months (for assessment of bone healing as is practiced normally) and a final x-ray will be taken after 3 months of the first x-ray (normally done in clinics for assessment of socket prior to implantation.

The OPG x ray is taken with the patient biting on a bite plate device fabricated with an embedded wire inside which is radiopague. If the distance from the wire line (the occlusal plane) to the alveolar bony height is 'a' and if the actual diameter of the metallic ball is 'b' and radiographic ball diameter is 'c' then the equation ( a×b)/c will give us the distance of the alveolar bony crest from the wire line. The measurements taken will determine if the distance of the alveolar crest from the wire line remained the same or has increased. If it remains the same, it will suggest that the scaffold material had maintained the socket and prevented alveolar bone resorption, but if the distance increases that will indicate vertical loss of alveolar bone and the extent measured can be compared with sockets without the support of an immediate post-extraction scaffold. This study will determine firstly whether the scaffold allows for bone regeneration in human alveolar sockets in the normal time and secondly whether it would help to preserve alveolar bone height as compared to cases without scaffold.

Consent of the selected patient will be taken for the procedure. Extraction will be done and scaffold material will be placed inside the socket. Socket with the scaffold will be our cases and the socket without scaffold will be the control group in multiple extraction cases. Radiographic assessment will be done to assess bone regeneration at the prescribed pre-extraction stage, at the 2 months bone healing stage and at the 3 months (from initial extraction) implant planning stage as in usual clinical practice . Assessment of the bony height is made with the prescribed formula from the radiographs taken and comparison will be made with the control cases. The following are the criteria for selecting the patients.

研究类型

观察性的

注册 (实际的)

33

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Tamil Nadu
      • Chennai、Tamil Nadu、印度、600077
        • Saveetha Dental College, Saveetha University
      • Singapore、新加坡、119074
        • Dental Centre, National University Hospital,

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 70年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

Dental clinic patients undergoing teeth extraction

描述

Inclusion Criteria:

  1. Under going extraction of tooth including the surgical extraction.
  2. Healthy individual with no known medical problems.
  3. Not allergic to foreign body.
  4. Extractions which are not due to periodontal causes.

Exclusion Criteria:

  1. Bony disease.
  2. Bleeding disorder.
  3. Allergic to foreign body.
  4. Mentally retarded persons.
  5. Diabetic patient.
  6. Drug addict.
  7. Extraction due to periodontal disease.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
1 Case with scaffold
This group of patients will be having a placement of PLGA bioscaffold in the alveolar socket after teeth extraction
2 Control without scaffold
The Alveolar socket will be left to heal and no treatment/scaffold placement will be done

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Preservation of Alveolar height
大体时间:3 months
3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Tai Weng Fan Victor, BDS FDSRCS、National University of Singapore, Faculty of Dentistry

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年5月1日

初级完成 (实际的)

2007年9月1日

研究完成 (实际的)

2008年7月1日

研究注册日期

首次提交

2009年2月3日

首先提交符合 QC 标准的

2009年2月3日

首次发布 (估计)

2009年2月4日

研究记录更新

最后更新发布 (估计)

2009年2月4日

上次提交的符合 QC 标准的更新

2009年2月3日

最后验证

2009年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • BSI-001-VF
  • DSRB A/06/404

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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