Fixation Free Sandwich Osteotomy for Vertical Ridge Augmentation in Aesthetic Zone Versus Conventional Sandwich Osteotomy: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- radiographical bone change
研究概览
简要总结
The atrophatic anterior maxilla present a considerable challenge for both surgical and prosthetic rehabilitation, as it may require bone augmentation to enable implant placement. The techniques proposed for vertical augmentation of the alveolar ridge include distraction osteogenesis, only grafting, and sandwich osteoplasty. Sandwich osteotomy is reported to provide more stable and predictable results with respect to the height of the alveolar ridge. The main advantage of osteotomy techniques that employ Interpositional bone grafts is reported to be the improved blood supply in the augmented region.
详细描述
the investigators aim to evaluate the radiographical, clinical differences of newly formed bone following vertical maxillary ridge augmentation using sandwich inlay with autogenous bone block from the rums without fixation (study group I) compared to same procedure with fixation (micro plates and screw) (control group).
description of intervention:
- diagnostic procedure:
- All Participant will be selected according to inclusion and exclusion criteria.
- Comprehensive clinical examination and understanding of patient's chief complaints will be carried out.
- All participants will be informed about the surgical treatment procedure and will provide their written consent to participate in the study.
- Preoperative panoramic radiograph will be requested prior as general screening for any pathosis and primary maxillary anterior residual bone height assessment.
- A (CBCT) scan will be requested for each patient to confirm amount of horizontal and vertical bone, to exactly measure the amount of bone height and to plan and guide surgical procedures of block graft.
- Alginate Impressions of upper & lower jaws will be taken for acquiring diagnostic dental casts.
intra-surgical procedure :
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)
盲法说明
both the participant and outcome assessor would not know to which group of study they belong investigator can not be masking
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adulte patient (18-60 y.)
- •Highly motivated patient with good oral hygiene
- •No systematic diseases or conditions known to alter bone healing.
- •No local pathosis that may interfere with bone healing.
- •No recent history of augmentation procedure at the same area.
- •Criteria of the edentulous ridge:
- •The anterior maxillary vertical dimension is minimum 10mm, measured from the crest of the ridge to the nasal floor.
- •Horizontal ridge dimension remains normal; at least 6mm.
- •The minimum number of the missing teeth is minimum 2 teeth and the maximum will be the six anteriors.
- •There will be increased inter-arch space compared with the adjacent teeth.
排除标准
- •uncontrolled Diabetes mellitus (DM)
- •pregnancy
- •uncontrolled local factors(periodontitis), or acute infection related to the aera.
- •smoking: more than 20 cigarettes \day
- •intravenous bisphosphonate
- •patients who had received radiation treatment in the head and neck region.
- •previous bone augmentation in the site within 6 months.
结局指标
主要结局
radiographical bone change
时间窗: 4- months
amount of bone change in millimeter using cone beam CT scan
radiographical bone gain
时间窗: 4-months
amount of vertical bone gain in millimeter using cone beam CT scan
次要结局
- clinical pain(1-3days)
- clinical infection(1-5 days)
- clinical edema(1-7 days)
- clinical dehiscence(1-30 days)
研究者
Heba Ashour Ammar
principal investigator
Cairo University