Horizontal augmentation of jaw bone by ridge split and expansion for implant placement in atrophic sites
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1.Alveolar ridge width measurement in all three groups
研究概览
简要总结
Sufficient alveolar ridge is essential for implant Rehabilitation in atrophic edentulous sites. Ridge splitting and expansion is one of the various methods of horizontal ridge augmentation. It enables simultaneous implant placement, eliminates the need for bone harvesting and reduces the risk of graft or membrane exposure. Therefore , the overall treatment time is shortened and morbidity is reduced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Physically and mentally healthy patient -Patients who will be willing and able to comply with the study related procedures.
- •Periodontally healthy patient with periodontal probing depth ≤ 3mm and good oral hygiene.
- •Patient having favourable and stable occlusal relationship and natural roots adjacent to the implant site.
- •Edentulous sites in maxilla and mandible must be free from infection.
- •At least 1-3 teeth missing.
- •Having a crestal width of atleast 3mm and an 8mm apico-coronal height from major anatomical structures.
排除标准
- •History of smoking, chewing tobacco, drug or alcohol abuse, para functional habits.
- •History of radiotherapy in the head and neck region for malignancies, bisphosphonate therapy.
- •Systemically unhealthy subjects.
- •Subjects with acute oral and gingival diseases.
- •Subjects with a history of allergy.
- •Unwillingness to sign consent form and review for all follow-up periods.
结局指标
主要结局
1.Alveolar ridge width measurement in all three groups
时间窗: 1. For alveolar ridge width, the timepoints are, before & after implant placement in comparator group and before (Pre-op) and after (post-op) ridge expansion in intervention groups | 2. For implant stability quotient, the time points are at the time of implant placement, 3rd month, 6th month | 3.For torque, the time point is at the time of implant placement
2.Implant stability quotient
时间窗: 1. For alveolar ridge width, the timepoints are, before & after implant placement in comparator group and before (Pre-op) and after (post-op) ridge expansion in intervention groups | 2. For implant stability quotient, the time points are at the time of implant placement, 3rd month, 6th month | 3.For torque, the time point is at the time of implant placement
3.Torque
时间窗: 1. For alveolar ridge width, the timepoints are, before & after implant placement in comparator group and before (Pre-op) and after (post-op) ridge expansion in intervention groups | 2. For implant stability quotient, the time points are at the time of implant placement, 3rd month, 6th month | 3.For torque, the time point is at the time of implant placement
次要结局
- 1.Pain
- 3. Soft tissue thickness(3.For soft tissue thickness, the time points are at the time of surgery, 4th week, 3rd month, 6th month after surgery)
- 4. IL-1β & TNFα (if feasible)(4.For IL-1β & TNFα, the timepoints are before prothesis & 2 weeks after prothesis( if feasible))
- 2. Redness & swelling(2.For redness & swelling, the time points are 1st week, 2nd week,4th week after surgery)