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临床试验/NCT04271423
NCT04271423已完成不适用

Alveolar Ridge Preservation Using a Flap Versus Flapless Technique Using a Demineralized Bone Matrix Allograft Plus Mineralized Particulate Allograft and a Calcium Sulfate Barrier

University of Louisville0 个研究点目标入组 24 人开始时间: 2006年4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
24
主要终点
Crestal Horizontal Ridge Width

研究概览

简要总结

To compare a flapless technique of alveolar ridge preservation to a flap technique to determine if preserving the periosteal blood supply would prevent loss of crestal ridge width and height.

详细描述

Twenty-four patients will randomly be assigned to receive ridge preservation using either flapless or flap technique. Twelve test patients will receive ridge preservation using a flapless approach and twelve control patients will receive ridge preservation using a flap technique. All sockets will be grafted with demineralized bone matrix and mineralized particulate allograft and covered with calcium sulfate barrier. Re-entry surgery will be performed at 4 months when a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.

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

  • Have one non-molar tooth requiring extraction that will be replaced with a dental implant where at least one adjacent tooth is present
  • Study subjects at least 18 years old
  • Patients must sign an informed consent approved by the University of Louisville Human Studies Committee of Institutional Review Board.

排除标准

  • Patients with debilitating systemic disease, or a disease affects the periodontium
  • Have an allergy to any material or medication used in the study
  • Require prophylactic antibiotics
  • Previous head and neck radiation therapy
  • Chemotherapy in the previous 12 months
  • Patients taking long term Non-steroidal Anti-inflammatory Drugs or steroid therapy
  • Smoked more than one pack of cigarettes per day

结局指标

主要结局

Crestal Horizontal Ridge Width

时间窗: 4 months after surgery

Changes in post-extraction to 4 month change in ridge measurements at the alveolar crest and 5 mm apical to crest. Measurements taken with a caliper.

次要结局

  • Percent osseous tissue(4 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

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