Evaluation of Oral Health-Related Quality of Life In Patients With Conventional Complete Dentures Versus Mini-Implant Retained Overdentures: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- OHRQoL
研究概览
简要总结
Mini-implants have emerged as a practical and less invasive solution for the rehabilitation of edentulous mandibles, offering reduced surgical complexity, lower cost, and faster healing compared to conventional implants. These advantages make them especially suitable for elderly patients or those with systemic health concerns or limited bone volume. Despite their growing clinical use, evidence from well-designed randomized controlled trials evaluating the impact of mini-implant-retained overdentures on patients' oral health-related quality of life (OHRQoL) is still scarce. Establishing this evidence is crucial for guiding treatment decisions in resource-constrained settings and improving the standard of care for edentulous individuals. This research aims to provide high-quality data on the effectiveness of mini-implants in improving OHRQoL, as measured by OHIP-14, compared to conventional dentures./
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
statistician
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completely edentulous mandible for a minimum period of 6 months Adult patients capable of understanding, cooperating, and providing informed consent Sufficient bone volume and interarch space in the anterior mandible to accommodate two mini-implants and overdenture attachments Good general health permitting minor oral surgical procedures Willingness to undergo follow-up visits and comply with study protocols
排除标准
- •Systemic medical conditions that preclude implant surgery, including poorly controlled chronic diseases such as diabetes mellitus or disorders affecting bone metabolism.
- •Patients taking medications known to affect bone metabolism (e.g., bisphosphonates, corticosteroids) Patients with physical or mental disabilities that impair oral hygiene maintenance or compliance Heavy smokers (>10 cigarettes/day) Individuals unable or unwilling to attend scheduled follow-up or participate throughout the study duration Patients who can receive standard implants with no anatomical limitations
研究组 & 干预措施
conventional dentures
干预措施: mini implant retained overdenture (Other)
mini implant retained overdenture
mini implant retained overdenture
干预措施: mini implant retained overdenture (Other)
结局指标
主要结局
OHRQoL
时间窗: 1 year
次要结局
未报告次要终点
研究者
Yasmien Emad Eldeen
assistant lecturer
Cairo University