Evaluation of Marginal Bone Loss of Two Immediately Loaded Implants Retaining Mandibular Overdentures With Ball Attachment Versus Intra Oral Welding Titanium Bar a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- marginal bone loss measurement
研究概览
简要总结
It is a randomized control clinical trial in which maxillary and mandibular dentures will be constructed, two implants will be inserted in the inter foraminal region in the edentulous mandible and immediate loading will be done. We will be comparing peri-implant marginal bone loss of two immediately loaded implants retaining mandibular overdentures with ball attachment versus intra oral welding titanium bar. Patient satisfaction will be assessed using oral health related quality of life.
详细描述
The patients will be divided in two groups, each group will receive maxillary and mandibular conventional heat cured acrylic resin complete dentures, which will be duplicated and provided by radio-opaque resin at the proposed implant sites to act as radiographic stents. Only patients with a D2 or D3 bone density will be included in the study. This will be confirmed by their cone beam computed tomographic (CBCT) scans of the mandible, while wearing radiographic stents.
The CBCT will be used to ensure sufficient bone width at the proposed implant sites, namely canine regions for implant diameter 3.7. Diagnostic set ups for all patients will be prepared to ensure a crown height space of at least 12 mm to accommodate the ball attachments for group I and intra oral welding bar for group II. Each group will receive two implants in the canine region through using surgical stent and immediate loading will be done.
Group B: immediate loading will be done using ball attachment and soft liners acting as female part for mandibular overdenture.
Group I: immediate loading will be done using intra oral welding titanium bar with 2 mm diameter and soft liner acting as a female part for mandibular overdenture.
For each group, marginal bone loss around the implants will be assessed at time of denture delivery and six months later. Patient satisfaction will be assessed using oral health related quality of life using (OHRQOL 14)
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
- Single (Outcomes Assessor)
盲法说明
Blinding will be done by the outcomes assessor and one of the study authors will remove the prosthetic part before measuring crestal bone loss by outcome assessor through cone paralling technique. Blinding of the outcomes assessor for assessment by oral health questionnaire will be done as well
入排标准
- 年龄范围
- 40 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •good oral hygiene
- •patient will be medically free
- •sufficient inter arch space
排除标准
- •heavy smoker
- •TMJ disorders
- •uncontrolled diabetes
- •flappy tissue
结局指标
主要结局
marginal bone loss measurement
时间窗: 6 months
marginal bone loss will be measured mesial and distal to the implant by radiographic cone paralling technique
次要结局
- patient satisfaction(6 months)
研究者
Ahmed Mostafa Abdelfatah
associate professor of oral and maxillofacial prosthodontics
Ain Shams University
