Evaluation of Straumann Bone Level Tapered® Implants Using Screwed Abutment Height in Partially Edentulous Patients: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Marginal Bone Loss
研究概览
简要总结
A prospective randomized controlled clinical trial will be conducted. Study groups will be assigned as described above. The patients will be randomly divided into two groups in order to study the influence of prosthetic screw abutment in marginal bone loss (MBL) around Bone Level Tapered implants (BLT® Roxolid® SLActive® guided implants, Straumann Dental Implant System, Institut Straumann AG, Basel, Switzerland).
详细描述
48 patients will be selected with partial edentulism in the maxilla or mandible, requiring two dental implants in the posterior areas (molars and premolars).
Each patient will be randomly allocated in one of the two groups: test group (n=36) or control group (n=12) and all the implants will be placed by residents of the International Master in Oral Surgery and Master in Periodontics of the same University.
Study groups
Group 1: Two stage approach (cover screw in first surgery and healing abutment in second surgery) (12 patients)
Group 2: One stage approach (healing cap over trans-epithelial abutments) (36 patients).Two subgroups according to different trans-epithelial height abutment:
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
- Double (Participant, 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
- 是
入选标准
- •Signed informed consent
- •Overall, healthy subjects
- •Females and males of at least eighteen-years
- •Requiring a minimum of two implants (molar and/or premolar teeth)
- •Adequate oral hygiene (less than 15% FMPS)
- •Able to follow instructions and attend a regular compliance
- •Enough bone to place a standard implant of 4.1 mm diameter.
排除标准
- •Acute local infection
- •Occlusal overload with parafunctional activity (assessed clinically)
- •Large occlusal discrepancies
- •Untreated periodontal disease assessed by Socransky et al. parameters (≥2mm clinical attachment loss in two consecutive visits within 1 year)
- •Smokers (more than 10 cigarettes/day)
- •Drug and/or alcoholic dependencies
- •Medical conditions contraindicating implant surgery
- •History of head and/or neck radiation
- •Bisphosphonate therapy
结局指标
主要结局
Marginal Bone Loss
时间窗: After implant loading (baseline)and once every year to 24 months follow-up
Periimplant bone level by measuring from the implant platform to the first bone to implant contact. Messuret in 2 points: MESIAL AND DISTAL with intra-oral XR. (measured in millimeters). The mean of this two-points for each implant was calculated. Afterwards, the mean for the mesial implants, distal and total implant sample per group was calculated.
次要结局
- Probing Depth(After implant loading (baseline)and once every year to 36 months follow-up)
- Bleeding on Probing(After implant loading (baseline)and once every year to 36 months follow-up)
- Keratinized Mucosa Width(After implant loading (baseline)and once every year to 36 months follow-up)
研究者
Jordi Gargallo-Albiol
Associate Professor of Oral and Maxillofacial Surgery
Universitat Internacional de Catalunya