NCT06178536已完成不适用
Clinical and Radiographic Assessment of a Novel Wedge Shape Implant Placed in Edentulous Narrow Ridges: Comparison of Bone Consuming and Bone Expanding Techniques for Implants Presenting Either Machined or Roughened Transcortical Portion
Christian Makary1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年6月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Implant stability
研究概览
简要总结
The aim is to clinically and radiographically assess a novel wedge implant placed in narrow ridges.
- 60 wedge implants (Rex Implants, Columbus, OH, USA) will be placed using Piezosurgery® following either a bone consumption (n=30) or bone expansion technique (n=30). Each group (bone consumption and bone expansion) will be divided into 2 surface treatments: machined transcortical portion (n=15) and roughened transcortical portion (n=15).
- Record the time needed to place each implant.
- ISQ will be evaluated at Day 0, 3 weeks, 6 weeks, 3 months, 4 months, and 6 months after implant placement.
- Periapical radiographs will be performed at implant placement, loading. and 1, 3, and 5 years after loading to assess marginal bone stability.
- Buccal bone height and lingual and buccal bone thickness will be recorded post-intervention, at the time of functional loading, and at 12, 36, and 60 months after loading with CBCT.
- Digital impressions will be taken post-operatively, at loading and at 12 months after loading to monitor gingival profile.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Partially or totally edentulous patients presenting indications for a prosthetic rehabilitation supported by the upper or lower jaw implants on the basis of an accurate diagnosis and treatment planning;
- •the bone crest must be completely healed (at least six months after the loss of teeth);
- •the residual bone crest must have a width between 3 and 5 mm;
- •presence of at least 10 mm of bone height available for implant placement; 5) patient age > 18 years;
- •the patient must not wear any type of removable dentures on the treated area; 7) the patient must be capable of following the study protocol; and 8) written informed consent must be provided
排除标准
- •acute myocardial infarction within the last two months;
- •Uncontrolled coagulation disorders;
- •uncontrolled diabetes (HBA1c> 7.5);
- •radiation therapy to the head \ neck region in the last 24 months;
- •immunocompromised patients, HIV positive or receiving chemotherapy in the last five years;
- •past or present treatment with intravenous bisphosphonates;
- •psychological or psychiatric problems;
- •abuse of alcohol or drugs;
结局指标
主要结局
Implant stability
时间窗: 0, 3 weeks, 6 weeks, 3 months, 4 months, and 6 months after implant placement.
Implant stability quotient evaluation
Bone stability
时间窗: At 6 months, and at 12, 36, and 60 months after loading
Periapical radiograph and CBCT
Gingival profile monitoring
时间窗: Day 0 of surgery, at 6 months and at 12 months.
Digital impression superimposition
次要结局
未报告次要终点
研究者
Christian Makary
Professor
Saint-Joseph University
研究点 (1)
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