Comparing Two Different Attachments Retaining Mandibular Implant Overdenture Regarding Bone Changes and Occlusal Force Distribution (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
- 2
- 主要终点
- Marginal Bone Changes
研究概览
简要总结
Alveolar ridge resorption is an unavoidable consequence in complete denture wearers due to limited retention and stability. Implant-retained overdentures enhance retention, stability, and masticatory performance while reducing ridge resorption and improving patients' quality of life.
Among attachment systems, ball-type anchors have long been favored for their simplicity and cost-effectiveness. However, the Equator attachment has emerged as a refined alternative, providing superior retention and stability for implant overdentures.
Functional performance can be evaluated through electromyography, which records masticatory muscle activity, and the T-Scan system, which analyzes occlusal force distribution and timing during dynamic occlusion. Additionally, bite force measurement serves as a key indicator of prosthetic efficiency and neuromuscular function, with implant-retained overdentures showing higher values than conventional dentures. This study aimed to compare bone level changes, occlusal force distribution in patients wearing mandibular implant overdentures retained by Equator and ball-and-socket attachments.
详细描述
All 24 patients will receive upper complete and lower complete overdentures. The upper complete denture will be mucosa supported while lower complete denture will be retained for by two dental implants in the inter-foraminal region. Patients will be divided into two equal groups; Group I will be retained by Ball and Socket attachment, while Group II will be retained by Equator attachment. Both groups will be functionally loaded after three months of insertion. This study aimed to compare bone level changes, occlusal force distribution in patients wearing mandibular implant overdentures retained by Equator and ball-and-socket attachments. Bone level changes will be measured using CBCT, While occlusal force will be measured using Tscan system.
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
- 55 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •All patients age must range from 55- 60 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
结局指标
主要结局
Marginal Bone Changes
时间窗: it will be measured at denture insertion, 6 month, and 12 month later
Marginal bone height changes around the two implants were evaluated through the software by measuring the distance from the alveolar crest to the implant apex in both coronal and sagittal views. The amount of bone loss was calculated by subtracting the measured distance between each radiographic evaluation made at the time of denture insertion and the recall appointments by superimposition of images and average was taken
次要结局
- Occlusal force distribution measurement(it will be recorded at the time of prosthesis insertion, 6 months, and 12 months after denture insertion.)
研究者
Noha Taha Kamel Taha Alloush
Lecturer
Misr International University