Impact of Wearing Two Different Implant Retained Mandibular Overdentures on Occlusal Force Distribution and Denture Retention (Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Occlusal force distribution
研究概览
简要总结
The global increase in the aging population has led to a rise in total edentulism, which remains a major public health concern. two-implant-retained mandibular overdentures have been regarded as the standard of care, offering superior retention, stability, comfort, and masticatory efficiency compared to conventional dentures. Among available attachment systems-bar, ball, stud, and magnet-the Equator attachment has gained popularity due to its low vertical profile, suitability for limited inter-occlusal space, and ease of handling.
Assessment of masticatory performance and occlusal balance can be objectively measured using devices such as bite force analyzers and the computerized T-Scan system, which quantifies occlusion and disocclusion times.
Conventional heat-cured polymethyl methacrylate (PMMA) remains the most widely used denture base material; however, it has mechanical and biological limitations. Flexible denture base materials have been introduced to overcome these drawbacks by enhancing adaptation, distributing occlusal loads more evenly, and improving comfort and retention.
详细描述
24 Patients will be randomly and equally divided into two treatment groups:
- Group 1: Each patient in this group will receive conventional maxillary and mandibular complete dentures made of heat-cured acrylic resin PMMA. In the mandible, two implants were inserted in the symphyseal area and retained by equator attachments.
- Group 2: Patients in this group received the same type of treatment as the patients in group 1, but the mandibular overdentures were made of the flexible acrylic resin "breflex" The present study will be performed to compare the difference in retention, occlusal force distribution, occlusion and disocclusion time, and bite force for implant retained mandibular over denture using PMMA and flexible dentures base materials
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
Mandibular complete dentures processed into heat cured acrylic resin
Mandibular complete dentures made of heat-cured acrylic resin (PMMA). In the mandible, two implants were inserted in the symphyseal area and retained by Equator attachments.
干预措施: Conventional acrylic resin denture (Procedure)
Mandibular thermoplastic nylon denture
Mandibular overdentures were made of the flexible acrylic resin breflex, In the mandible, two implants were inserted in the symphyseal area and retained by Equator attachments.
干预措施: Flexible resin denture (Procedure)
结局指标
主要结局
Occlusal force distribution
时间窗: Follow up visits were scheduled at denture insertion, 6, and 12 months
Occlusal force distribution will be measured by T-Scan, The latest version (T-Scan III) provides a dynamic visual evaluation of a patient's occlusion from initial tooth contact to maximum intercuspation. The system records relative force values and allows objective quantitative evaluation of occlusal balance by recording numerical values for occlusion and disocclusion times
次要结局
- Retention of lower denture(Follow up visits were scheduled at denture insertion, 6, and 12 months)
- occlusion time(Follow up visits were scheduled at denture insertion, 6, and 12 months)
- Biting force(Follow up visits were scheduled at denture insertion, 6, and 12 months)
- Disocclusion time(Follow up visits were scheduled at denture insertion, 6, and 12 months)
研究者
Noha Taha Kamel Taha Alloush
Lecturer
Misr International University