Evaluation of the Efficiency of Guided Biaxial Alveolar Distraction Device in Posterior Atrophic Mandible (A Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- change in wound healing
研究概览
简要总结
Atrophic alveolar bone presents a unique difficulty, preventing correct implant placement and affecting long-term results. There are different techniques that are recommended to restore the proper length of the posterior ridge of the mandible and thus achieve proper form and function, one of those is distraction osteogenesis. Refinements in the technique of distraction can improve the treatment outcome and decrease postoperative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with the posterior atrophic mandible.
- •The distance from the alveolar crest to the upper border of the canal is not less than 5 mm.
- •Adult patients from 30-60 years old with no gender predilection who agreed to present for follow-up visits for a minimum postoperative period of 4 months.
- •Patientswithanadequateoralhygiene.
- •The patient should be psychologically accepting of the involved procedures.
排除标准
- •Medically compromised patients contradicting operation (ASA III, IV & V).
- •Patients receiving radiotherapy or chemotherapy or bisphosphonate.
- •Bonediseases(Osteoporosis,Osteopetrosis,Osteomalacia...etc.)
- •Any habits that might retard healing such as heavy smoking and alcoholism.
- •A history of any grafting procedure at the designated area.
结局指标
主要结局
change in wound healing
时间窗: at 1, 7 and 14 days
The sutured wounds will be examined for wound dehiscence as (Yes for present and No for absent)
Change in mental nerve reflex
时间窗: Baseline, after 2 weeks and 1 month
Mental nerve blink reflex responses to electrical stimuli given with a small bipolar pediatric stimulating electrode to the center of the mental nerve distribution on the chin and lower lip on each side will be recorded bilaterally with surface electrodes on the orbicularis oculi muscles with Viking IV EMG equipment
Change in bone density
时间窗: Baseline,1 month, 3 months
Bone density at the distracted area, the length will be gained and displacement of transported segment lingually will be evaluated using CBCT
Change in Pain scorre
时间窗: at 1, 7 and 14 days
It will be assessed on daily basis for one week through a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
次要结局
未报告次要终点
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University