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临床试验/NCT02660697
NCT02660697已完成4 期

3D Radiographic Evaluation of Post-extraction Healing Following Treatment With a Novel Implant Site Development Technique

Semmelweis University1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2007年12月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
43
试验地点
1
主要终点
Orovestibular socket dimension

研究概览

简要总结

The present retrospective study aims at assessing the clinical effects of a novel implant site development (Extraction site development - XSD) technique after tooth extraction compared with extraction alone in patients requiring dental implant placement following healing of extraction sockets.

详细描述

In advanced (Extraction Defect Sounding Class 3-4) alveolar defects, a minimally invasive tunnelised socket preservation technique utilising long term resorbable membranes and connective tissue grafting was used for extraction site development (XSD). The novel technique was evaluated in a retrospective comparative case series study including a total of 54 extraction sites. In the test group, out of 33 single rooted teeth, 29 in the maxilla and 4 in the mandible were removed, extractions sites were treated by the XSD method. Out of 33 teeth, 27 were incisors, 2 canines and 4 premolars. In the control group, out of 21 single rooted teeth, 11 in the maxilla and 10 in the mandible were extracted and left for spontaneous healing. Out of 21 teeth, 13 were incisors, 2 canines and 6 premolars. CBCT scans were taken prior to tooth extraction and 6-9 months later in both groups. Radiographic evaluation was carried out using the I-CAT Vision (Imaging Sciences International, LLC; Hatfield, USA) and ImageJ (National Institutes of Health) softwares. Following manual alignment of CBCTs vertical and horizontal linear measurements as well as planimetric measurements of cross-section areas were performed in pre- and postoperative data sets at the extraction sites.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Presence of at least 1 single rooted tooth scheduled for extraction with EDS Class 3-4 type buccal bony dehiscence

排除标准

  • •Exclusion criteria int he test group included uncontrolled inflammation at the surgical site, full mouth plaque or bleeding scores more than 20%, diabetes, pregnancy, known metabolic bone diseases, smoking more than 10 cigarettes a day, history of any relevant systemic diseases, radiotherapy chronic use of bisphosphonates or systemic steroids.

研究组 & 干预措施

Test - Extraction site development group

Active Comparator

In the test group 29 healthy patients presenting 33 single rooted teeth scheduled for extraction with Extraction Defect Sounding (EDS) Class 3-4 type buccal bony dehiscences were included. 29 maxillary single rooted teeth and 4 single rooted teeth in the mandible (27 incisors, 2 canines and 4 premolars) were removed and treated by the novel extraction site development method. Pre- and postoperative ConeBeam Computer Tomography (CBCT) data were collected for further analysis.

干预措施: Extraction site development (Procedure)

Control - Spontaneous healing group

No Intervention

In the control group. pre- and postextraction CBCT data sets of 14 patients with 21 extracted teeth were collected. 11 maxillary single rooted teeth and 10 single rooted teeth in the mandible (13 incisors, 2 canines and 6 premolars) were extracted and left for spontaneous healing.

结局指标

主要结局

Orovestibular socket dimension

时间窗: From baseline to 6-9 months postoperatively

On prealigned pre- and postoperative CBCT cross-sections, linear measurements were taken parallel to a reference base to determine the orovestibular width of extractions sites

次要结局

  • Minimal orovestibular socket dimension feasible for implant placement(From baseline to 6-9 months postoperatively)
  • Vertical socket dimension(From baseline to 6-9 months postoperatively)
  • Socket area(From baseline to 6-9 months postoperatively)

研究者

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

Balint Molnar

Dr. Balint Molnar DMD, PhD, assistant professor

Semmelweis University

研究点 (1)

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