Prosthetic Complications of Screw Retained Restoration Using Multi-unit Abutments Versus Intra-oral Luting on Titanium Base in Implant Supported Complete Overdentures Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Abutment screw loosening
研究概览
简要总结
On of the main fixed prosthetic options of completely edentulous patients is the screw-retained implant supported prosthesis which was constructed on transmucosal abutments with its encountered problems such as: hardness to make it passively seated with multiple screw fracture and loosening problems and multiple encountered veneer material fracture and so there effect on patient satisfaction with multiple maintenance recalls.so, the investigators want to try a new technique of fabrication which was proposed for reducing the problems of lack of passivity which is the intraoral luting cement technique on titanium bases with reduced screw number but, with luting cement problems as de-cementation and cement biological effects on soft tissues and bone and there effect on number of patient recall visits and maintenance and so there effect on patient satisfaction
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
Allocation sequence generation will be performed by the Senior supervisor. Enrolment of participants will be performed by the principle investigator where the patients will be assessed for eligibility.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Completely edentulous patients
- •Patients with completely edentulous ridges have an opposing natural dentition or implant supported overdenture
- •Completely edentulous patients (with the above mentioned criteria) who have proper amount of attached gingiva (≥2 mm) or to be created
- •Completely edentulous patients (with the above mentioned criteria) who have no history of bruxism
- •Completely edentulous patients (with the above mentioned criteria) who were free or controlled diabetic assessed by measuring glycosylated haemoglobin (HbA1c). (lesser than or equal to 6.4 percent )
排除标准
- •- Patients having a medical condition that absolutely contraindicates implant placement.
- •Patients with uncontrolled diabetes, assessed by measuring glycosylated haemoglobin (HbA1c). (greater than to 6.4 percent )
- •Potentially uncooperative patients who are not willing to go through the proposed interventions. - Moderate-to-heavy daily smokers* (who report consuming at least 11 cigarettes/day).
- •Patients who are having complete lower denture
- •Patients who have history of bruxism
研究组 & 干预措施
titanium bases group
full-arch screw-retained implant prosthesis on titanium bases using intra oral luting cement technique
干预措施: titanium bases using intra oral luting cement technique (Procedure)
transmucosal abutment group
a full-arch screw-retained implant prosthesis with transmucosal abutment
干预措施: transmucosal abutment (Procedure)
结局指标
主要结局
Abutment screw loosening
时间窗: 12 months
Measuring device :Clinical visual inspection / Measuring unit:Binary
次要结局
- Abutment screw fracture(12 months)
- Ti-bases de-cementation(12 months)
- Prosthetic screw loosening(12 months)
- Prosthetic screw fracture(12 months)
- Veneer fracture(12 months)
- Framework fracture(12 months)
研究者
mostafa said hosny
Assistant lecturer
Cairo University