Short vs Long Implants Supporting a Total Fixed Prosthetic Rehabilitation of the Fully Edentulous Mandible. A Multicenter Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Marginal Bone Level (MBL) Change
研究概览
简要总结
The aim of this study is to clinically and radiographically compare the performance of short (6 mm-long) versus long (≥11 mm-long) dental implants placed in the interforaminal region of fully edentulous mandibles, supporting a screw-retained full-arch cantilever bridge.
详细描述
The use of short dental implants provides undeniable benefits in sites where the reduced available volume would otherwise need bone augmentation procedures and their use has greatly expanded in the recent years. However, well designed clinical trials which provide a sound evidence of their performance and reliability are still lacking to date.
In this post-market, multi-center, open, parallel-group, randomized, controlled clinical trial the investigators aim to to clinically and radiographically compare the performance of short (6 mm-long) versus long (≥11 mm-long) dental implants supporting a mandibular screw-retained full-arch cantilever bridge.
Five 4mm-wide/6mm-long (test) or 4mm-wide/≥11mm-long (control) titanium dental implants (Osseospeed™, ASTRA TECH Implant System™, Dentsply Sirona) are placed in the interforaminal region of fully edentulous mandibles, in non-regenerated sites, with at least 1 mm of peri-implant bone circumferentially.
All products are CE (European Conformity) marked and used within their intended use.
Two-Stage surgery is performed, implants are positioned in healed bone and exposed after 3 months to be connected with the prosthesis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •total edentulous patients in the lower region since at least 8 months,
- •sufficient amount of native bone (no augmentation procedures) in the recipient sites to allow ≥11 mm long and 4 mm wide implant installation (≥1 mm of peri-implant bone circumferentially)
- •systemic health
- •compliance with good oral hygiene
- •informed consent signed.
排除标准
- •any disease, medication or drug that could jeopardize healing, osseointegration or treatment outcome,
- •untreated caries or periodontitis of the remaining teeth,
- •mucosal and bone tissue lesions,
- •severe bruxism or other parafunction habits,
- •unrealistic aesthetic demands,
- •patient taking part to another study
结局指标
主要结局
Marginal Bone Level (MBL) Change
时间窗: 5 years from baseline (prosthetic loading)
Marginal bone level (MBL) is measured as the distance in millimiters calculated on periapical radiographs from the implant neck to the most coronal bone-to-implant contact point at both the mesial and the distal side of each implant. The radiographs will be taken with an X-ray apparatus supplied with a long cone and Rinn's film holders.
次要结局
- Implant Survival Rate(5 years from baseline (prosthetic loading))
- Prosthesis Survival(5 years from baseline (prosthetic loading))
- Biological Complications(5 years from baseline (prosthetic loading))
- Technical Complications(5 years from baseline (prosthetic loading))
研究者
Luigi Guida
Full Professor
University of Campania Luigi Vanvitelli