跳至主要内容
临床试验/CTRI/2025/04/085422
CTRI/2025/04/085422尚未招募Phase 3 4

3D Strut plate versus delta plate in management of mandibular condylar fracture- a prospective randomised clinicoradiographic comparative study

Sardar Patel Post Graduate Institute of Dental and Medical Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月5日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Primary Outcome is to compare the clinical and radiological outcomes of 3D strut plate with delta plate in the treatment for condylar fractures of mandible and to asses occlusal discrepancy, Maximum interincisal opening, bite force, fracture stability, restoration of ramus height and post operative complications

研究概览

简要总结

Thedata for this study will be collected from the patients with fractures ofcondyle of mandible who visit the Out Patient Department (OPD) of Oral and Maxillofacial Surgery, Sardar Patel Post Graduate Institute of Dental and Medical Sciences,and Dr. O.P. Chaudhary Hospital and Research Centre, Lucknow, will be thesubjects of the study. Eachpatient will be asked for written informed consent after being fully informedabout the procedure’s nature, expected results, and potential side effects.Patient will be selected irrespective of caste, creed, sex,religion or socio-economic status. Eachpatient will be randomly allocated to group A and group B using lotterymethod. Surgical procedure will be performed under General Anaesthesia.Patient will be laid on the operating table and Intravenous line will besecured. Anaesthesia will be induced by Propofol and maintained by Halothaneand O2+ N2O. Nasotracheal intubation will be done.Surgical site preparation, draping, and maxillomandibular fixation will bedone. Local infiltration will be given. Following the preparation of thesurgical sterile field, surface markings will be made and the zygomatic arch,mandibular condyle, and ramus up to the angle will be identified. After that,the fracture end will be described. There will be a conventionalretromandibular incision made. The periosteum is raised and the fractureis located once the surface of the bone is reached. The Langenbeck retractor,which is positioned at the sigmoid notch, will be used for the reduction. Next,a 2 mm system 5-hole Strut subcondylar plate made of titanium will bepositioned at the fractured site, with its short arm situated slightly belowthe sigmoid notch and its long arm parallel to the ramus’s posterior border.The plate will be secured in place by five 8 mm titanium screws, or thefracture site will have a delta plate placement using four 8mm screws, with thebase of the plate pointing in the mandibular angle’s direction. After fixingthe plates, Maxillo-mandibular Fixation will be released and occlusion will bechecked. The extraoral incision will be sealed with 4-0 Prolene on the skin and3-0 Vicryl in the deep layers. Along with Maxillo-mandibular Fixation trainingelastics will also be placed on all the patients since second post-operativeday for 2 weeks. Patients will be evaluated immediately following surgery, aswell as one, two, three, and six weeks later. Two weeks following surgery, Maxillo-mandibularFixation will be released, and following the fourth post-operative week, archbars will be taken out. All the patients to be given a high dose of antibioticsand analgesics post-operatively. Patients will receive strict instructionsregarding oral hygiene.

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
19.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Condylar fractures with or without occlusal discrepancy.
  • Displaced and undisplaced both types of condylar fracture.
  • American Society of Anaesthesiologist Classification (ASA) I and II patient.
  • Condylar fractures: unilateral or bilateral.

排除标准

  • Edentulous mandible fracture.
  • Pre-existing discrepancies in skeleton Pathological problems that were present in the temporomandibular joints before.
  • Condylar head fracture Condylar fracture associated with any other mid-face fracture.
  • Severely comminuted along with infected fracture.
  • Patients who are not fit to undergo procedure under general anaesthesia.
  • Previous history of irradiation of head and neck area.

结局指标

主要结局

Primary Outcome is to compare the clinical and radiological outcomes of 3D strut plate with delta plate in the treatment for condylar fractures of mandible and to asses occlusal discrepancy, Maximum interincisal opening, bite force, fracture stability, restoration of ramus height and post operative complications

时间窗: The estimated time may range upto 6 months

次要结局

  • Secondary outcome is to assess pain, facial nerve funtion, post operative complications(The estimated time may range upto 6 months)

研究者

发起方
Sardar Patel Post Graduate Institute of Dental and Medical Sciences
申办方类型
Research institution

研究点 (1)

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