Peri-Implant Marginal Bone Loss And Implant Stability In Maxillary Implant Overdenture When Using Osseodensification Versus Conventional Drills: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Peri-implant marginal bone loss
研究概览
简要总结
Is to compare between the conventional drills versus osseodensification drills for implant stability and peri-implant marginal bone loss in maxillary implant overdenture.
详细描述
Comprehensive clinical examination and understanding of patient's chief complaints and their expectations from the prosthesis.
- medical and dental history
- A complete denture will be constructed for each patient to aid in the scan technique, if the patient has an denture, it will be evaluated to be used.
- The complete denture will be constructed following conventional denture fabrication procedures.
- CBCT radiograph will be taken for bone height and width, and identify the vital structures before implant placement.
- A surgical guide will be used to aid in the implant placement, each patient will be scheduled for surgery to insert four root form implants. Each patient will receive four implants at canine and premolar regions from the same implant manufacturer.
Study group: The osseodensification drilling group (G1), bone preparation was performed using tapered multifluted burs (Densah Bur; Versah, MI, USA) at 800- 1200 rpm counterclockwise rotation under saline irrigation. Drilling to the desired depth using the tapered densah pilot drill with speed of 800-1200 rpm with copious irrigation without any lateral pressure with clock wise motion.
Control group: In the conventional drilling group (G2), drilling the other contralateral sites of bone using the conventional sequential drilling system according to the manufactural instruction.
- All patients received 2gm/day amoxicillin, clavulanate and 50 mg/8 hours non-steroidal anti-inflammatory analgesics for 5 days postoperatively. Postoperative instructions included a soft diet and appropriate oral hygiene measures with 0.2% chlorhexidine mouth rinse.
- After four months, the implants will be exposed and attachment (stud attachment) will be screwed to the implants. Then, overdenture pick-up is done. * Number of visits & follow up period
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with completely edentulous maxilla.
- •Sufficient inter-arch space not less 13mm inter-arch space.
- •sufficient bone height to allow usage of at least 10mm implant length.
- •Normal maxilla-mandibular relationship.
- •minimum radiographic bone width bucco-palatally in canine and premolar regions to place at least 3.5mm implant diameter.
- •participants more than forty years old.
- •Opposing fully or partially restored dentition.
排除标准
- •1- Skeletal mal-relation. 2- Unmotivated patients to maintain adequate oral hygiene to follow up. 3- Patients with neuromuscular and Psychiatric disorders. 4- Systematic disease affecting bone and periodontal health such as diabetic patients.
- •5- Insufficient inter-arch space less than 13mm. 6- Patients with physical reasons that could affect follow up. 7- patients administrating antibiotics 8- smoker patients 9- patients with any systemic or local condition that obstacles implant placement 10- patients with a history of radiotherapy in the head and neck region
结局指标
主要结局
Peri-implant marginal bone loss
时间窗: 1 year
Radiographic follow up will be performed for marginal bone loss. Serial of standardized digital periapical radiographs using; long cone paralleling technique, XCP periapical film holder and an individually constructed radiographic acrylic template will be taken at the time of implant placement (base line) then at 4,12 months.
次要结局
- Implant stability measurements(4 months)
研究者
Marwa Essam El-Dein Mohamed
lecture assistant
Cairo University