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临床试验/NCT04299750
NCT04299750Unknown不适用

Impact of Alveolar Ridge Preservation on Optimal Implant Placement

Simone Lumetti2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
32
试验地点
2
主要终点
Number of implants ideally placed

研究概览

简要总结

The aim of this study is to investigate how a socket preservation procedure may reduce the need of guided bone regeneration surgery after tooth extraction and facilitate the placement of a dental implant in the optimal, prosthetic-driven position.

详细描述

The main gol of the study is to assess the efficacy of a socket preservation procedure in reducing the need of additional surgeries in order to augment alveolar bone volume before placing a dental implant in optimal position. Bone volume at 6 months will be compared to initial volume in order to assess volume variations and how they affect the positioning of a prosthetically driven, implant.

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

  • at least 18 years of age
  • at least one intercalate tooth to be extracted, with complete alveolus and no soft tissue recession;
  • adequate oral hygiene, i.e. plaque index score ≤10%;
  • mesial-distal width of inter-dental space ≥7 mm;

排除标准

  • American Society of Anesthesiologists (ASA) score ≥III
  • presence of active periodontitis, clinically diagnosed in presence of probing depths ≥4 mm and bleeding on probing
  • a history of radiotherapy to the head and neck region
  • presence of conditions requiring chronic use of antibiotics
  • medical conditions requiring prolonged use of steroids
  • history of leucocyte dysfunction
  • history of bleeding disorders
  • history of renal failure
  • patients with metabolic bone disorders
  • patients with uncontrolled endocrine disorders
  • disability affecting oral hygiene
  • alcohol or drug abuse
  • HIV infection
  • smoking >10 cigarettes a day or cigar equivalents
  • conditions or circumstances that would prevent completion of study participation
  • mucosal diseases
  • presence of osseous lesions
  • severe bruxing or clenching habits
  • persistent intraoral infections
  • compromised alveolus (dehiscence, etc)

结局指标

主要结局

Number of implants ideally placed

时间窗: 6 months

The main goal is to determine if alveolar ridge preservation affects optimal implant positioning. This is defined as the implant position allowing to fulfill the ideal prosthetic design of the crown to be restored.

次要结局

  • Ridge volume at 6 months after tooth extraction(6 months)
  • Peri-implant bone variation(6 months)

研究者

发起方
Simone Lumetti
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Simone Lumetti

DDS, PhD, MSc

University of Parma

研究点 (2)

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