3D Printing/Additive Manufacturing of Single- Implant Overdentures. A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Implant survival
研究概览
简要总结
A randomized clinical trial (RCT) was designed. The participants were randomly allocated into either of the two groups intervention or control group each of 14 participants. Participants in control group (Group-A) received conventional manufactured implant overdenture while participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.
详细描述
Introduction
Mandibular single implant overdenture is a well-established treatment modality that address limited financial resources of patients and simultaneously enabled the management of conventional complete denture problems. CAD/CAM technology helped to mitigate the problems encountered with conventional fabrication techniques, which results in improved dentures fit and retention. Therefore, the aim of the current trial study was to evaluate whether overdentures fabricated using CAD/CAM printed technology exhibited improved patient satisfaction, denture retention, implant survival rate and decreased post-insertion maintenance or not compared to overdentures manufactured using conventional techniques.
Methods: A randomized clinical trial (RCT) was designed. The participants were randomly allocated into either of the two groups intervention or control group each of seven participants. Participants in control group (Group-A) received conventional manufactured implant overdenture while participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the participant should be completely edentulous ranging in age from 35 to 75 years
- •Angle's class I skeletal relationship
- •normal facial symmetry
- •adequate inter-arch space not less than 12mm
- •should be a cooperative patient -
排除标准
- •temporomandibular disorders
- •uncontrolled diabetes
- •bleeding disorders or anticoagulant therapy
- •flabby tissues or sharp mandibular residual ridge
- •neuromuscular disorders
- •Angle's class II and III skeletal relationship.
- •Patients who were heavy smokers
- •chemotherapy or radiotherapy or with severe psychiatric disorders
结局指标
主要结局
Implant survival
时间窗: 1 year
The implants were considered surviving if they were clinically stable, functioning without any mobility
次要结局
- maximum biting force (MBF)(1 year)
- Survival rate of overdentures(1 year)
研究者
Dina ElAwady
lecturer of Prosthodontics (principal investigator)
October University for Modern Sciences and Arts