Comparing Two Different Attachments Retaining Mandibular Implant Overdenture Regarding Retention and Patient Satisfaction (Randomized Clinical Trail)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Retention
研究概览
简要总结
The Goal of the clinical trail is to evaluate the efficacy of Bar- OT Equator attachment on retention and patient satisfaction in comparison to the standard technique using Bar- clip attachment.
Patients will visit the clinic after the surgery and after the attachment insertion for check ups and during the follow up periods ( at denture insertion, 3 months and 6 months)
详细描述
patients will receive upper complete dentures and lower complete overdentures. The upper complete denture will be mucosa supported and the lower complete denture will be supported and retained for all patients by two dental implants in the inter-foraminal region. Patients will be divided into two equal groups; Group I will be retained by Bar-Clip attachment, while Group II will be retained by Bar- OT Equator attachment. Both groups will be functionally loaded after three months of insertion.
Retention of lower denture will be measured using digital force gauge and Patient satisfaction was evaluated with a standard 5-point Liker scale questionnaire. All parameters will be measured at denture insertion, 3 month, and 6 month later.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients age must range from 60- 70 years old.
- •All patients' ridges should be covered with firm mucosa free from any signs of inflammation or ulceration and exhibit adequate height and width of the residual alveolar ridge.
- •Patients should be free from any metabolic or bone disorder that contraindicate implant installation.
- •All patients must have sufficient inter arch space
排除标准
- •Patients with oral or systemic diseases.
- •Patients with xerostomia or excessive salivation.
- •Patients with parafunctional habits (bruxism or clenching).
- •Heavy smoker or alcoholic patients.
- •Patients with history of temporo-mandibular dysfunction.
- •Patients with brain disorders or psychiatric disorders
研究组 & 干预措施
Bar-Clip attachment
on the 2nd stage, implants will be loaded with bar-clip attachments to support overdenture
干预措施: Bar-Clip attachment (Procedure)
Bar- OT Equator attachment
on the 2nd stage, implants will be loaded with Bar- OT Equator attachments to support overdenture
干预措施: Bar- OT Equator attachment (Procedure)
结局指标
主要结局
Retention
时间窗: it will be measured at denture insertion, 3 month, and 6 month later
Retention will be measured using digital force gauge A digital force meter was used to measure denture resistance to vertical displacement (i.e., retention) by applying a pulling force on a metal hook located in the geometric center of each mandibular conventional denture that was identified on the lower cast at the intersection of three lines bisecting the angles of the triangle, formed by both retromolar pads and the midline. Measurement of mandibular denture retention: The patient was instructed to place his head on chin rest and occlusal plane was set parallel to the floor. Tongue freedom was checked then and three minutes seating time was allowed before taking the measurements. A vertical pulling force was applied using the metallic probe of the digital force-meter that was attached to the hook present at the geometric center of mandibular denture. Average value of six readings was recorded.
次要结局
- Patient satisfaction(it will be measured at denture insertion, 3 month, and 6 month later.)
研究者
Noha Taha Kamel Taha Alloush
Lecturer
Misr International University