Clinical and Radiographical Performance of Zirconia Bars for Mandibular Implant Overdentures: A 3-year Follow-up Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Implant Success
研究概览
简要总结
Purpose: To assess the clinical and radiographic outcomes of computer-aided designed and manufactured (CAD-CAM) zirconia bars supporting mandibular implant-retained overdentures (IODs) after a 3-year follow-up.
Methods: A prospective observational single-center study involving 30 edentulous patients rehabilitated with two mandibular implants and a mandibular implant overdenture supported by a computer-aided design - computer-assisted manufacturing zirconia bar with distal extensions was performed assessing clinical and radiographic parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Edentulous individuals for more than one year.
- •Individuals with sufficient anatomical bone conditions in the interforaminal area to place implants of 4.3mm in diameter and at least 10.0mm in length without bone augmentation needs.
- •Written consent to participate and to attend the study and the yearly follow-ups.
排除标准
- •Individuals suffered from psychiatric problems.
- •History of cerebrovascular or cardiovascular accident within the last six months.
- •Uncontrolled or insulin-dependent diabetes, immuno-compromised status, current chemotherapy, and leukocyte system diseases.
- •Severe systemic health conditions do not allow surgical intervention with local anesthesia.
- •Irradiated bone.
- •Severe parafunctional habits
- •Drugs or alcohol abuse.
- •Insufficient oral hygiene.
- •Unrealistic treatment demands.
- •Smokers were not excluded, but a cessation protocol was suggested before the implant treatment.
- •Unwillingness to participate in the study.
研究组 & 干预措施
Zirconia bars with distal extensions
Two mandibular implants and a mandibular implant overdenture supported by a computer-aided design
干预措施: Two mandibular implants (Device)
结局指标
主要结局
Implant Success
时间窗: 36 months
Number of patients with absence of persisting subjective discomfort such as pain, foreign body perception and or dysesthesia (i.e., painful sensation), absence of a recurrent peri-implant infection with suppuration, absence of implant mobility on manual palpation, absence of any continuous peri-implant radiolucency
Implant Survival
时间窗: 36 months
Number of patients with continued presence of the implant(s) during the re-examination appointments
Prosthetic Success
时间窗: 36 months
Number of patients with absence of any technical/mechanical complications without the need to repair the dentures (including the attachment systems) or the bars
Prosthetic Survival
时间窗: 36 months
Number of patients with functional presence of the denture and the bar at the follow-up moments
Radiological evaluation
时间窗: 36 months
Marginal bone loss
Radiological examination
时间窗: 36 months
Implant bar fit
次要结局
未报告次要终点