A Prospective clinical and radiographic evaluation of TTPHIL ALL TILT treatmentprotocol using Bioline I implant system for partially and completely edentulousmaxilla and mandible
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- An implant will be considered successful (100% survival rate) if fulfilled function of supporting full-arch restoration, stable when tested clinically, no radiolucency on radiographs, and no peri-implant inflammation or suppuration. Therefore, the implant survival rate will be determined based on Malo’s criteria. Prosthetic success: A prosthesis was considered a failure if function was compromised for any reason. Fracture of the implant or any prosthetic component will be recorded, as will be technical complications with the abutments or other prosthetic components up to 2 years of function.
研究概览
简要总结
Abstract:
The scope of full mouth rehabilitation using implants have increased considerably as edentulism is prevalent in about 10 percent of world population. Increase in chewing surfaces along with elimination of cantilever for the long term functional and bio-mechanical success, irrespective of the bone type is significant from patient’s and clinician’s viewpoint. There is no single technique which can be used in all types of bone. thus TTPHIL- ALL-TILT treatment protocol attempts to fill that gap.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •All cases of complete edentulism, even in resorbed maxilla and mandible.
- •For the mandible, residual ridge crest of at least 4 mm width buccolingually and greater than 8 mm height; for the maxilla, residual ridge crest with enough width to insert a 3.5 mm–diameter implant, and greater than 8 mm height will be included in the study.
- •Immediate and delayed loading cases
- •Patients, in whom grafting procedures or zygomatic implants would be morbid or medical conditions wherein such invasive surgical procedures are contraindicated can undergo TTPHIL-ALL TILT® protocol.
排除标准
- •Severely debilitating systemic disease.
- •Patients undergoing chemotherapy and radiotherapy.
- •Restricted mouth opening of the patient such that access of posterior regions of maxillary and mandibular arches are compromised.
- •Evaluation appointments will be performed at 6 months; 1 year; and 2 years for assessing implant survival.
- •The primary outcome measure was implant and prosthesis survival based on function up to 2 years.
- •The secondary outcome measures included marginal bone level evaluation and the incidence of biological and esthetic complications up to 2 years of function.
结局指标
主要结局
An implant will be considered successful (100% survival rate) if fulfilled function of supporting full-arch restoration, stable when tested clinically, no radiolucency on radiographs, and no peri-implant inflammation or suppuration. Therefore, the implant survival rate will be determined based on Malo’s criteria. Prosthetic success: A prosthesis was considered a failure if function was compromised for any reason. Fracture of the implant or any prosthetic component will be recorded, as will be technical complications with the abutments or other prosthetic components up to 2 years of function.
时间窗: 10 days; 2, 4,and 6 months; 1 year; and every 6 months
次要结局
- The secondary outcome measures included marginal bone level evaluation and soft tissue assessment at 6 months, 1 and 2 years of function.(Biological complications: Peri-implantitis, peri-implant mucositis, fistula, bleeding on probing, suppuration, and numbness of the lower lip or chin will be evaluated.)