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临床试验/NCT04482127
NCT04482127已完成不适用

Post-extraction Volumetric Analysis of Alveolar Ridge Contour Using Subepithelial Connective Tissue Graft in Esthetic Zone: A Randomized Controlled Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2020年3月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Buccal soft tissue contour

研究概览

简要总结

This study will monitor the effect of soft tissue augmentation using sub-epithelial connective tissue graft buccal to extraction sockets in anterior maxilla in thin dento-alveolar phenotype; and will evaluate whether it will enhance the alveolar ridge contour and improve the gingival phenotype following atraumatic extraction compared with no treatment at all in terms of Ridge contour Preservation for future esthetically acceptable fixed prothesis.

详细描述

The aim of this study is to assess the alveolar ridge contour after soft tissue augmentation using sub-epithelial connective tissue graft buccal to fresh extraction sockets in patient with thin buccal bone, versus atraumatic extraction with no soft tissue augmentation.

Group A: Patients receiving atraumatic extraction with soft tissue augmentation by sub-epithelial connective tissue graft buccal to extraction sockets.

Group B: Patients receiving normal atraumatic extraction with no soft tissue augmentation

Clinical examination:

  • Evaluation of the patient's general condition of the oral cavity, to make sure it complies with the criteria required to be enrolled in the study in terms of oral hygiene and pathological conditions.
  • Evaluation of the buccal bone thickness using CBCT as diagnostic aid. (After CBCT if the patient was excluded because of thick buccal bone, he/she will be referred for implant placement)
  • Evaluation of gingival phenotype before extraction using visual technique via periodontal probe.
  • After patient enrollment, full mouth scaling to be done first and home oral hygiene measures to be done by patient. At the day of the surgery, immediately before extraction, an impression will be taken using alginate material and wax molded stock tray for recording the original ridge contour as the baseline data. casts will be made with dental extra hard stone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults from the age of 18 - 40 years
  • Patients with non-restorable maxillary teeth/tooth indicated for extraction in the area from 2nd premolar to 2nd premolar
  • Intact gingival tissue with at least 2mm keratinized tissue
  • Buccal bone thickness should be 1mm or less assessed by CBCT before extraction
  • Periodontally healthy patients
  • Patients accepts to provide informed consent

排除标准

  • Pregnant females.
  • Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).
  • Handicapped and mentally retarded patients.
  • Patients undergoing radiotherapy.
  • Presence of systemic disease that would affect wound healing.
  • Presence of active infection with soft tissue communication.

结局指标

主要结局

Buccal soft tissue contour

时间窗: 6 Months

Volumetric analysis using pre and post impressions and a digital software (V.Vanhoutte, et al. 2013) (Van Nimwegen, et al 2018). The soft tissue contours of the extraction sites will be assessed quantitatively. Impressions will be taken at 3 time-points, that is, before tooth extraction (baseline, T0) and 3 (T1), and 6 (T2) months after surgery. Plaster casts will be generated subsequently and digitised with a laser scanner. For the final analyses, CAD software is to be used to match the corresponding follow-up states (T1 to T2) with the baseline state (T0) and evaluate sections at defined positions with standardization of the apico-coronal dimension of SCTG.

次要结局

  • Gingival Thickness(6 Months)
  • Interdental Papilla height(6 months)

研究者

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

Gamal A Aziz

Masters Student at Cairo University

Cairo University

研究点 (1)

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