Effect of Using Two Different Attachments Supporting Mandibular Overdenture on Retention and Quality of Life (Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Retention
研究概览
简要总结
This randomized clinical trial investigates the effect of two different attachment systems-Equator and Novaloc-on the retention, patient satisfaction, and oral health-related quality of life of mandibular implant overdentures. Completely edentulous patients often experience reduced denture stability, compromised chewing ability, and diminished oral function with conventional complete dentures. Implant-retained overdentures have been shown to improve retention, stability, and overall patient satisfaction. Equator attachments offer a small, resilient, and self-aligning system with variable retention levels, while Novaloc attachments feature innovative PEEK caps and a diamond-like carbon coating designed to reduce wear and maintain long-term retention. This study aims to determine whether one attachment system provides superior functional outcomes and patient-centered benefits, thereby guiding clinicians in optimizing overdenture therapy for edentulous patients."
详细描述
All 26 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 randomly divided into two equal groups; Group I will be retained by Novaloc attachment. While, Group II will be retained by Equator attachment. Implants will be functionally loaded after three months of insertion.
Retention of lower denture will be measured using digital force gauge, Oral health quality of life will be measured by verbal The Oral Health Impact Profile (OHIP) questionnaire. Patient satisfaction was evaluated with a standard 5-point Liker scale questionnaire. All parameters will be measured at denture insertion, 6 month, and 12 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' ages 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
OT-Equator Attachment
On the 2nd Stage, implants will be loaded with OT-Equator Attachment to retain overdenture
干预措施: OT-Equator Attachment (Procedure)
Novaloc Attachment
On the 2nd Stage, implants will be loaded with Novaloc Attachment to retain overdenture
干预措施: Novaloc Attachment (Procedure)
结局指标
主要结局
Retention
时间窗: It will be measured at denture insertion, 6 months and 12 months
it will be measured using digital force gauge
次要结局
- The Oral Health Impact Profile (OHIP) questionnaire(It will be measured at denture insertion, 6 months and 12 months)
- Patient Satisfaction(it will be measured at denture insertion, 6 month, and 12 month later.)
研究者
Noha Taha Kamel Taha Alloush
Lecturer
Misr International University