Short Dental Implants (5 mm) Versus Long Dental Implants (10 mm) in Combination With Sinus Floor Elevation: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in Mesial-distal (M-D) Bone Loss
研究概览
简要总结
The purpose of this study is to evaluate the survival rate of 5 mm short implants compared to longer implants (10 mm) placed in sinus-grafted sites.
Primary aim: Compare bone loss between the two groups Secondary aim: Compare surgical time and patient-reported outcomes (satisfaction and post-operative pain)
详细描述
34 patients requiring an implant to replace an upper missing tooth in the premolar or 1st molar area with a bone crest height from 5 to 8 mm will be recruited for this trial. Patients will be randomized to either the test (5-mm implant) or control group (10-mm implant) using a computer-generated randomization list . 17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant while the other 17 patients will receive a 5 mm short implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20-70 years at enrollment
- •Systemically healthy patients
- •Full-mouth plaque score and full-mouth bleeding score ≤ 30% (measured at four sites per tooth)
- •In need of one premolar or 1st molar dental implant in the maxillary area
- •Neighboring teeth to the planned implant must have natural root(s) or implant supported restoration.
- •Presence of natural tooth/teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crown/s deemed by the investigator as likely to present an initially stable implant situation
- •Residual bone height under the maxillary sinus between 5 to 7 mm and a width of at least 7 mm, as measured on cone beam computer tomography (CBCT) scans.
排除标准
- •Unlikely to be able to comply with study procedures
- •Uncontrolled pathologic processes in the oral cavity
- •History of head and neck chemotherapy within 5 years prior to surgery
- •Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
- •Uncontrolled diabetes mellitus HbA1c >8
- •Taking corticosteroids, IV bisphosphonates, or any other medication that could influence post-operative healing and/or osseointegration
- •Smokes more than 10 cigarettes/day
- •Present alcohol and/or drug abuser
- •Pregnant, unsure pregnancy status, or lactating females (self-reported)
结局指标
主要结局
Change in Mesial-distal (M-D) Bone Loss
时间窗: Baseline, surgical visit 1 day, 4 months, 5 months, 12 months, 24 months
Comparing mesial-distal (M-D) bone loss between the two groups. This will be measured in millimeters using standardized radiographs of the implant site at the screening visit, surgical visit, 4 months post-op, 5 months post-op, 12 months post-op, and 24 months post-op visits.
次要结局
- Survival Rate(5 month post-op, 12 month post-op, and 24 month post-op visits)
- Number of Sites With Bleeding on Probing(5 month post-op, 12 month post-op, and 24 month post-op visits)
- Probing Pocket Depth(5 month post-op, 12 month post-op, and 24 month post-op visits)
研究者
Tae-Ju Oh
Clinical Professor of Dentistry
University of Michigan