Comparision between 5 hole strut plate and 4 hole delta plate for treatment of fractures of the head of the lower jaw.

Phase 3

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2025/04/085422

Lead Sponsor: Sardar Patel Post Graduate Institute of Dental and Medical Sciences

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	The estimated time may range upto 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary outcome is to assess pain, facial nerve funtion, post operative complications	The estimated time may range upto 6 months

Trial Locations

Locations (1): Out Patient Department of Oral and Maxillofacial Surgery
🇮🇳
Lucknow, UTTAR PRADESH, India
Out Patient Department of Oral and Maxillofacial Surgery
🇮🇳Lucknow, UTTAR PRADESH, India
Dr Ayushi Jha
Principal investigator
9643280799
ayushi80799@gmail.com