A Pilot Randomized Clinical Study Comparing Patient-Reported Outcomes and Complications for Mandibular Implant Overdentures Retained by Different Splinted Attachment Systems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- patient-reported outcomes
研究概览
简要总结
This exploratory pilot randomized clinical study enrolled ten completely edentulous participants who experienced retention and stability problems with conventional mandibular complete dentures. Participants were randomly allocated to receive mandibular implant-supported overdentures retained by either a bar-locator attachment system (n = 5) or a bar-ball attachment system (n = 5). Denture satisfaction was assessed using the McGill Denture Satisfaction Questionnaire
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility criteria incomplete mandibular edentulism for at least one year, adequate bone volume in the interforaminal region to permit implant placement, a documented history of insufficient retention and/or stability with a conventional mandibular complete denture.
排除标准
- •comprised uncontrolled systemic diseases, previous radiotherapy to the head and neck region, severe parafunctional habits, and any medical or local contraindications to implant surgery.
研究组 & 干预措施
Group2: Patients were given overdentures with bar ball attachments
干预措施: overdentures with bar ball attachments (Other)
Group I (bar locator): Patients were given overdentures with bar locator attachments,
干预措施: overdentures with bar locator attachments (Other)
结局指标
主要结局
patient-reported outcomes
时间窗: Patient satisfaction (primary outcome) at T0 and after 6 months of overdenture insertion
Patient satisfaction (primary outcome) between bar locator and bar ball using a McGill-based study at T0 and after 6 months of overdenture insertion
complications
时间窗: prosthetic complication was evaluated From enrollment to the end of treatment at 3 years
prosthetic complication between bar locator and bar ball
次要结局
未报告次要终点
研究者
Heba Wageh Abozaed Elsaed Mansour
Principle investigator
Mansoura University