Influence of Different Abutment Shape on Peri-implant Marginal Bone Loss: A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Peri-implant bone level changes
研究概览
简要总结
A study designed as a randomized controlled trial of parallel group design will be conducted at the Dental clinic of the University of Valencia to evaluate the influence of 2.5 mm high abutments with different shapes (commercially available high abutments vs high abutments with modified shape to imitate short abutments) on peri-implant bone loss around bone level implants with platform switching in partially edentulous patients that require a fixed rehabilitation supported by two implants in the posterior mandible or maxilla and in fixed rehabilitation supported by one implant in the anterior mandible or maxilla.
详细描述
A study designed as a randomized controlled trial of parallel group design will be conducted at the Dental clinic of the University of Valencia to evaluate the influence of 2.5 mm high abutments with different shapes (commercially available high abutments vs high abutments with modified shape to imitate short abutments) on peri-implant bone loss around bone level implants with platform switching in partially edentulous patients that require a fixed rehabilitation supported by two implants in the posterior mandible or maxilla and in fixed rehabilitation supported by one implant in the anterior mandible or maxilla (from premolar to premolar).
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, Investigator)
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
- •Any subject requiring two implants in the posterior mandible or maxilla, being at least 18 years old and able to sign an informed consent. Final patient inclusion will be made after flap elevation during the implant placement surgery to be able to confirm the presence of a vertical thickness ≥ 3mm of keratinized soft tissues.
- •Bone volumes should allow the placement of implants at least 8 mm long (i.e, 10 mm bone height to the inferior alveolar nerve) and 4.2 mm wide (7 mm wide bone crest) without bone regeneration procedures.
- •Patients will be grouped into: 1) non smokers; 2) light smokers (≤ 10 cigarettes/day); 3) heavy smokers (≥ 11 cigarettes/day)
排除标准
- •Patients unable to commit to follow-up.
- •General contraindications to implant surgery.
- •Immuno-suppressed/immune-compromised patients.
- •Patients irradiated in the head and/or neck.
- •Uncontrolled diabetes.
- •Pregnancy or lactation.
- •Untreated periodontal disease.
- •Poor oral hygiene and motivation.
- •Addiction to alcohol or drugs.
- •Psychiatric problems and/or unrealistic expectations.
- •Patients with an acute infection (abscess) or suppuration in the site intended for implant placement.
- •Patients treated or under treatment with intravenous amino-bisphosphonates.
- •Patients referred only for implant placement if the follow-up cannot be done at the treatment center.
- •Patients participating in other studies, if the present protocol could not be fully adhered to.
结局指标
主要结局
Peri-implant bone level changes
时间窗: 12 months after implant loading
Assessed on digital periapical radiographs taken with the paralleling technique at delivery of crowns (implant loading) and 12 months afterwards.
次要结局
- Probing pocket depth(12 months after implant loading)
- Bleeding on probing(12 months after implant loading)
- Peri-implant soft tissue recession(12 months after implant loading)
- Implant survival rate(12 months after implant loading)
研究者
David Peñarrocha Oltra
Assistanat Postdoctoral Lecturer (Profesor Ayudante Doctor)
University of Valencia