Completely Edentulous Patients Screw-retained Maxillary Complete Denture With Electric Welded Metal Framework Versus Cast One, Patient Satisfaction Assessment (Randomized Control, Split Mouth Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- patient satisfaction
研究概览
简要总结
In this study the investigators are going to compare the effect of electric welded metal frame work and cast frame work on patient satisfaction and maintenance of the final prosthesis.
详细描述
In this study twelve completely edentulous patients will be enrolled and In each patient six implants will be inserted in the maxillary arch at crestal bone level in predefined positions (positions 15, 13, 11, 21, 23, 25) with the help of a surgical template following a submerged healing protocol and checked for primary stability clinically. After a 4-month osseointegration period, second-stage surgery will be performed and healing abutments will be placed. After the second-stage surgery, prosthetic procedures will be initiated.
then for one side (the intervention side) the metal framework will be constructed as follow: A preexisting or prepared flat surface area of the welding abutment of implant at central incisor position at one side (right or left) will serve as the welding point. A titanium bar will be shaped following the curvature of the implants positioned. At this point, temporary titanium implant abutments will be welded with the titanium bar in the oral cavity, using the Syncrystallization Unit .The welding process is electrical and protected by an argon gas supply (Syncrystallization). The equipment allows the welding of metallic elements directly in the mouth. Current flowing through the contact points, being in contact with the parts to weld, warms up to the point of fusion, achieving a solid, welded junction. Then will be placed between the two electrodes of a welding clamp. The energy contained in a previously unloaded battery of capacitors is transferred to the electrodes of the welding cycle is subdivided in three stages: Pre-gas, welding, and post-gas phase. While the pre-gas phase allows an oxygen-free welding point prior to the actual fusion, the post-gas phase ensures the absence of oxygen and subsequent oxidation during cooling. Finally, the prosthetic framework, created by welding the titanium bar to the implant abutments, will be removed and opaque will be applied in order to avoid metal shining through the acrylic resin.
for the other side :
At the day of second stage surgery restoration will be fabricated as follow:
For the cast metal framework group, CCM abutments (Titanium base abutments with a plastic cast able sleeve) will be fastened over the analogues of the placed implants, on a verified analogue model.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range from 45 to 65 years old.
- •Absence of any medical disorder that could complicate the surgical phase or affect osseointegration .
- •The patients must be completely edentulous.
- •The patient must have enough bone height for implants, minimum length of bone 10mm and a minimum diameter of bone 5 mm.
- •Patients with good oral hygiene.
- •Complete denture wearer.
- •Adequate inter arch space for screw retained prosthesis.
- •Absence of any intra-oral pathological condition.
排除标准
- •Patients with recent extraction(less than three months).
- •Patients with inflamed ridge or candida infection.
- •Patients with flappy ridge.
- •Para functional habits.
结局指标
主要结局
patient satisfaction
时间窗: 12 months
satisfaction assessed by Boerrigter's method questionnaire.in this questionnaire, there are three aspects to consider:(1) problems with the denture itself;(2) masticating ability; and (3) overall denture performance. different answers to each question are assigned scores and the total score can be calculated for further evaluation and analysis.
次要结局
- Maintenance of the final prosthesis(12 months)
研究者
fatma hussein abd elmonem
Principal Investigator
Cairo University
