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临床试验/NCT01268982
NCT01268982已完成2 期

Dimensional Changes of the Alveolar Ridge Contour After Socket Preservation, Stability of Implants Placed, and Histological Evaluation of Newly Formed Bone at These Sites.

Mashhad University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2010年1月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
32
试验地点
1
主要终点
soft and hard tissue vertical and horizontal changes

研究概览

简要总结

In this study, the investigators will evaluate the dimensional changes of alveolar bone in the preserved sites in comparison with extraction only conventional healed sockets, as well.

  1. Dimensional changes of the alveolar ridge contour after socket preservation in comparison to conventional tooth extraction.
  2. Evaluation the stability of implants placed at the preserved sockets.
  3. Histological evaluation of newly formed bone at the socket preserved sites in comparison with extracted only healed sites.

详细描述

Nineteen systematically healthy patients (10 female and 9 male; mean age 38 years old; range 19-57) providing 32 hopeless non-molar teeth were selected and divided into 2 treatment groups: In the test group, following tooth extraction, for 16 sockets (9sockets from 5 female and 7 sockets from 5 male patients) soft and hard tissue measurements include horizontal (Bucco-Lingual dimensions at 1mm,3mm and 7mm at the mid portion from the line connecting two adjacent CEJs) and vertical ridge dimensions (vertical distance from the line connecting two adjacent CEJs at 8 points: Mid-Buccal, Mid-Lingual, Mesial, Distal, Disto-Buccal, Disto-Lingual, Mesio-Buccal, Mesio-Lingual around the socket) will be determined using a caliper and a template. All sockets will be filled with DFDBA and covered with absorbable membrane. Primary coverage will be achieved by full thickness mucosal flap advancement over each socket. Then an acid-etch bridge will be applied for the sites, both to avoid the movement of adjacent teeth to the empty space & also for patients esthetics. 6 months following the procedure, the soft and hard tissue in all the sites will be measured again as it was mentioned previously, plus the measurements gained from CBCT radiographs.

Besides, biopsy will be harvested from some of the preserved sites that has enough width with the use of trephine bur no.3 and it was sent for histological evaluation. Subsequently, Implants will be installed in the preserved sites and the implant stability will be measured with the help of Ostell device. The stability will be measured after 4 month following implant insertion with the same device while the implant undergoes the implant exposure procedure.

In control group, 16 sockets (9 sockets from 5 female, and 7 sockets from 4 male patients) served as unfilled extraction only group. Following extraction, soft and hard tissue measurements (horizontal and vertical ridge dimensions) will be determined with the use of caliper and template.

6month after extraction, CBCT will be taken from the site and at the time of implant installation, the soft and hard tissue in all sites will be measured in vertical and horizontal dimensions. Furthermore, biopsy from some of the healed sockets with enough width will be taken with the use of trephine bur no.3 and it will be sent for histological examination.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
19 Years 至 57 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Non-molar hopeless teeth
  • •lack of bone volume for ideal implant placement

排除标准

  • •Patient's un-wiliness for involvement in the project
  • •contraindication of surgery due to medically-related problems

研究组 & 干预措施

preserved socket

Experimental

sockets will be filled with DFDBA and covered with absorbable membrane. Primary coverage will be achieved by full thickness mucosal flap advancement over each socket.

干预措施: socket preservation (Procedure)

结局指标

主要结局

soft and hard tissue vertical and horizontal changes

时间窗: 6 months

soft and hard tissue measurements include horizontal (Bucco-Lingual dimensions at 1mm,3mm and 7mm at the mid portion from the line connecting two adjacent CEJs) and vertical ridge dimensions (vertical distance from the line connecting two adjacent CEJs at 8 points: Mid-Buccal, Mid-Lingual, Mesial, Distal, Disto-Buccal, Disto-Lingual, Mesio-Buccal, Mesio-Lingual around the socket)

次要结局

  • histologic evaluation and implant stability measurement(10 months)

研究者

申办方类型
Other

研究点 (1)

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