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临床试验/NCT01934530
NCT01934530已完成不适用

Implant Associated Soft Tissue Defects in the Anterior Maxilla: A Randomized Control Trial Between Subepithelial Connective Tissue Graft and Acellular Dermal Matrix Allograft

University of Michigan2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Recession Correction

研究概览

简要总结

This randomized controlled clinical pilot trial compared the efficacy of two soft tissue grafting methods for correcting esthetic discrepancies associated with non-molar implants in the maxilla. Specifically, it was explored whether defects treated with connective tissue grafts (SCTG) differed in their outcomes from defects treated with acellular dermal matrix allografts (ADM).

详细描述

Thirteen patients who presented with implants displaying recession, thin biotype, concavity defects or a combination thereof associated with single crowned dental implants participated in this randomized control trial. The control group (N=7) received SCTG and the test group (N=6) received ADM, both under coronally positioned flaps. Data were collected before surgery, and 6 weeks, 3 months, and 6 months after the surgery. Outcome measures included soft tissue, hard tissue, and esthetics parameters and psychosocial data.

研究设计

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

入排标准

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

入选标准

  • Healthy adults of at least 18 years of age
  • Maxillary non-molar implant with failing pink esthetic profile
  • Implants with adjacent landmarks (only one can be an implant)
  • Healthy implants measured by the lack of peri-implantitis and mucositis
  • Good oral hygiene.

排除标准

  • Unstable systemic diseases, compromised immune system, or unstable bleeding disorders
  • History of radiation or cancer in the oral cavity
  • Use of IV bisphosphonate or steroid medication
  • Use of tobacco products (>1/2 pack per day)
  • Pregnancy
  • Mucogingival surgery or implant placement within the past six months

结局指标

主要结局

Recession Correction

时间窗: 6 Months

Change in recession was recorded at baseline, 6 weeks, 3 months and 6 months after grafting.

次要结局

  • Concavity Correction(6 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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