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临床试验/NCT03684356
NCT03684356
Unknown
3 期

Comparison of the Dimensional Changes of Hard and Soft Peri-implant Tissues Around Single Immediate Post-Extraction Implants in the Esthetic Zone With Socket Shield Technique Versus Using Xenograft: A Randomized Controlled Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 22 人2019年2月22日
适应症Socket Shield

概览

阶段
3 期
干预措施
未指定
疾病 / 适应症
Socket Shield
发起方
Cairo University
入组人数
22
试验地点
1
主要终点
pink esthetic score
最后更新
6年前

概览

简要总结

The aim of this study is to clinically and radiographically evaluate the dimensional changes of soft and hard peri-implant tissues around single immediate post-extraction implants in the esthetic zone.

详细描述

to compare the efficacy of the socket shield technique in counteracting the dimensional changes of the soft and hard peri-implant tissues to filliing the buccal gap with xenograft. * Population (P): Patients with single non-restorable tooth in the esthetic zone. * Intervention (I): Immediate implant placement with socket shield technique. * Comparator (C): Immediate implant placement and filling the buccal gap with xenograft. * Primary Outcome (O): Pink Esthetic Score (PES) (Fürhauser et al., 2005). * Time frame: 9 months (Chu et al., 2015). * Study design: Randomized controlled clinical trial.

注册库
clinicaltrials.gov
开始日期
2019年2月22日
结束日期
2020年12月
最后更新
6年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Mohamed Atef Abd El Moneium

assistant lecturer

Cairo University

入排标准

入选标准

  • Patient's age was 18 years or older.
  • Non-restorable tooth in the upper inter-bicuspid area.
  • Adequate bone volume for the placement of immediate implant.
  • Following tooth extraction, there was an intact socket bony wall (type I extraction socket).
  • Primary stability of the implant was achieved at the time of the implant placement.

排除标准

  • Patients who reported tobacco use in the past 5 years.
  • Patients who had severe periodontal destruction at the site of implant placement.
  • The presence of any signs of acute infection in the surgical site or the adjacent two natural teeth.
  • Patients who had history of any systemic disease that precludes the placement of implants.
  • Any disease that might affect bone metabolism as osteoporosis.
  • Patients taking medications that might affect bone turn over as bisphosphonates.
  • Physically or mentally handicapped patients.
  • Pregnant females.
  • Teeth with vertical root fractures on the buccal aspect
  • Teeth with any other pathologies affecting the buccal part of the root, for example, external or internal resorptions.

结局指标

主要结局

pink esthetic score

时间窗: 9 months

Pink esthetic score evaluates the soft tissue esthetics around implant supported crowns. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value. The maximum achievable PES is 14. 7 variables are measured: mesial and distal papillae being 0 if absent, 1 if incomplete and 2 if complete. Alveolar process, soft tissue level, contour, texture and color being 0 if major discrepancy, 1 if minor discrepancy and 2 if matches the contralateral

次要结局

  • Corono-apical peri-implant bone dimensional changes(6 months)
  • Bucco-lingual peri-implant bone dimensional changes(6 months)
  • Recession of the buccal peri-implant mucosa(9 months)
  • Patient satisfaction: VAS(9 months)

研究点 (1)

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