Additively (AM) Versus Subtractively (SM) Manufactured Implant Supported Fixed Dental Prostheses (iFDPs)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Clinical success
研究概览
简要总结
This research is being done to evaluate the clinical, technical, biological, and aesthetic results of two different fabrication methods (additive and subtractive) for creating implant-supported fixed dental prostheses (iFDPs). Patients will receive an iFDP, meaning an implant-supported crown, according to regular treatment protocols. The fabrication method used to create the implant-supported crown will be decided in a randomised way. Clinical and radiological examinations will be performed prior to and when receiving the implant-supported crown and during a follow-up period of 3 years. Furthermore, technician- and patient-reported outcomes will be evaluated used questionnaires.
详细描述
This study is designed as a randomised controlled clinical trial with a multi-centre design. Patients in need of a definitive posterior implant-supported crown will be enrolled in this study following predefined eligibility criteria at two different study centres (Harvard School of Dental Medicine, Harvard University and Center of Dental Medicine, University of Zurich). Patients will receive a single implant-supported crown fabricated according to group allocation (additively or subtractively manufactured). After crown delivery, patients will be followed-up for an observation period of 3 years. The primary outcome is the clinical performance of the implant crowns. Clinical, technical, biological, and aesthetic results as well as the technician- and patient-reported outcomes will be assessed.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form in English language
- •≥ 20 years of age
- •In need of at least one definitive screw retained premolar or molar iFDP on an existing dental implant (Straumann AG)
- •Presence of at least one adjacent tooth at the implant site
- •Adequate oral hygiene
- •Capability to comply with the study procedures
排除标准
- •Pregnant or lactating women
- •Known or suspected non-compliance, drug or alcohol abuse
- •Severe periodontal and peri-implant disease
结局指标
主要结局
Clinical success
时间窗: This outcome will be evaluated at the baseline and at the follow-up visits after 1 year, 2 years and 3 years
The primary outcome is clinical success of the iFDPs, which is defined as the iFDPs being free of all complications over the entire observation period.
次要结局
- Efficiency during manufacturing (dental technician) (time)(Periprocedural)
- Efficiency during manufacturing(Periprocedural)
- Chairside adjustment time(Periprocedural)
- Survival rate(This outcome will be reported on the baseline visit and the follow-up visits after 1, 2 and 3 years)
- Probing Depth(This outcome will be assessed at the baseline visit and the follow-up visits after 1, 2 and 3 years.)
- Esthetic outcomes(This outcome will be assessed at the baseline visit and the follow-up visits after 1, 2 and 3 years.)
- Technical outcomes(this outcome will be assessed at the baseline visit and the follow-up visits after 1, 2 and 3 years.)
- Patient-reported outcomes(This outcome will be assessed at the baseline and follow-up visits after 1, 2 and 3 years)
- Adverse events(through study completion. This outcome will be reported at baseline and follow-up visits after 1, 2 and 3 years.)
- Bleeding on probing (BOP)(This outcome will be assessed at the baseline visit and the follow-up visits after 1, 2 and 3 years.)
- Plaque control record(This outcome will be assessed at the baseline visit and the follow-up visits after 1, 2 and 3 years.)
研究者
German O. Gallucci
Professor
Harvard Medical School (HMS and HSDM)