Evaluation of Patient Satisfaction Using Autogenous Inlay (Sandwich) Eminoplasty Versus Patient Specific Poly Ether-ether Ketone (PEEK) Onlay Implant in Treatment of Chronic Condylar Dislocation A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 7
- 主要终点
- Patient satisfaction: Question
研究概览
简要总结
Aim of the study:
The aim is minimize morbidity in treatment of TMJ dislocation. Hypothesis: Alternate hypothesis that treatment tmj dislocation with PEEK eminoplasty will be more efficient than using autogenous inlay technique
PICO:
Problem (P): patients with un pleasant painful dislocated tmj Intervention (I): eminoplasty with patient specific poly ether-ether ketone (PEEK) onlay implant Control Group (C): autogenous inlay (sandwich) eminoplasty Outcome (O): patient Satisfaction, dislocation treatment (normal range of mouth opening), less morbidity.
详细描述
Aim of the study:
The aim is minimize morbidity in treatment of TMJ dislocation. Hypothesis: Alternate hypothesis that treatment tmj dislocation with PEEK eminoplasty will be more efficient than using autogenous inlay technique
PICO:
Problem (P): patients with un pleasant painful dislocated tmj Intervention (I): eminoplasty with patient specific poly ether-ether ketone (PEEK) onlay implant Control Group (C): autogenous inlay (sandwich) eminoplasty Outcome (O): patient Satisfaction, dislocation treatment (normal range of mouth opening), less morbidity.
- Trial design: Type: Parallel, two arm, randomized clinical trial. Allocation ratio: 1:1 Superiority framework
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
- None
盲法说明
because the two intervention in this trial are clearly different and easily recognized by participant and investigator , neither investigators nor participant can be blinded
入排标准
- 年龄范围
- 22 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patient with recurrent dislocation with maximum inter incisal opening over 55mm
- •Long-standing dislocation of the TMJ involving both fixation for more than 3 weeks and the failure of manual reduction
- •Failure of conservative strategies such as orientation to self-limit jaw movement and the use of a chin-cap or bandage
- •Both sexes
- •Age between 18 and 48 years.
- •Highly motivated patients.
排除标准
- •Post-menopausal females with osteoporosis
- •Patient with uncontrolled systemic disease
- •pregnancy
- •psychological disorders, drug or alcohol dependency
- •Known allergies or sensitivities to dental materials, including PEEK, Titanium or general anesthetic agents
- •Inability to return for follow up visits.
- •Refusal of participation from the patient
研究组 & 干预措施
PEEK eminoplasty
CT scan with bony window for facial bones and DICOM files on CD .then, Using cad cam software (mimics 15) , the virtual design and surgery will be done.
under general anathesia The TMJ will be exposed using the endural incision line and the articular eminence will be identified then blunt dissection so that the front wall of the articular capsule can be exposed completely.
- The patient specific PEEK eminence will be inserted and secured with two to three pre-planed screws .
- Functional mandibular movements were reproduced to confirm absence of subluxation and then closure
干预措施: PEEK eminoplasty (Device)
autogenous onlay grafting eminoplasty
under general anesthesia , chin graft was taken Layered Endural approach to TMJ making wedge in eminence by mallet & chisel (green stick fracture), then wedging piece of chin graft to increase the height of the eminence creating an obstacle to treat dislocation by manipulation of patient mandible intra operative.
- Functional mandibular movements were reproduced to confirm absence of subluxation then closure
干预措施: autogenous onlay grafting eminoplasty (Procedure)
结局指标
主要结局
Patient satisfaction: Question
时间窗: up to 4 month after operation
Questioning the patient about if there is any dislocation or any limitation to mandibular movement
次要结局
- Maximal Incisal Opening(follow up for 4 month)
- Post operative pain: VAS(follow up for 2 weeks up to 4 month)
- Intra operative time(during operation)
研究者
mustafa gamal abdel kawy
resident of oral & maxillofacial surgery department
El-Galaa Military Medical Complex