Role of temporalis fascia and buccal fat pad in the management of temporomandibular joint ankylosis: A clinico-radiographic comparative study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Primary outcome is to evaluate the efficacy of buccal fat pad and temporalis fascia for managing TMJ ankylosis and to assess the maximum interincisal mouth opening
研究概览
简要总结
The objective of our re-search is to access the efficaciousness of temporal fascia and buccal pad of fat in the TMJ ankylosis management and evaluate, compare, and analyze various clinical and radiographic parameters at different intervals.
Primary objective-
Clinical assessment
- Maximum interincisal mouth opening (in mm)
Secondary objectives-
Clinical assessment
-
Pain (according to Visual Analog Scale)
-
Transient Facial paresis (House Brackmann scale)
-
Infection (pus discharge and wound dehiscence at operated site)
Radiographic assessment
- Maintenance of the intra-articular space (OPG and CT scan)
The data for this study will be collected from patients who visit the Out Patient Department (OPD) of Oral and Maxillofacial Surgery at Sardar Patel Post Graduate Institute of Dental and Medical Sciences. Prior to participating in the study, each patient will be provided with a detailed explanation of the procedure, its possible outcomes, consequences, and complications. Written informed consent will be secured from every patient, regardless of their caste, creed, sex, religion, or socio-economic status.Patients will be randomly assigned into two groups i.e., Group A and Group B utilizing Lottery Method.
All patients will undergo surgery under general anaesthesia. Pre-operative antibiotics and Tetanus prophylaxis will be administered. Nasotracheal intubation will be done using fiber-optic bronchoscope followed by surgical part preparation and draping. General anaesthesia will be induced using propofol and will then be maintained by isoflurane and O2 and N2O. Local anaesthetic infiltration with 2% lignocaine with 1:80,000 adrenaline will be given at the planned incision site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 8.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anaesthesiologists (ASA) Group I & II patients Unilateral TMJ ankylosis Sawhneys type 3 and type 4 Patient ready to give informed consent Patients willing to perform postoperative mouth opening exercises as per instruction.
排除标准
- •Medically compromised patient Patients not willing for surgery Patients deemed medically unfit to undergo procedure under general anaesthesia.
结局指标
主要结局
Primary outcome is to evaluate the efficacy of buccal fat pad and temporalis fascia for managing TMJ ankylosis and to assess the maximum interincisal mouth opening
时间窗: The estimated time may range from 6th month to 1 year
次要结局
- Secondary outcome is to evaluate the efficacy of buccal fat pad and temporalis fascia for managing TMJ ankylosis and to assess the pain, transient facial paresis, infection, maintenance of intra-articular space.(The estimated time may range from 6th month to 1 year)
研究者
Dr Aakriti Kumari
Sardar Patel Post Graduate Institute of Dental and Medical Sciences