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The functional outcomes of adult mandibular condylar fractures with open surgical techniques versus closed reduction modalities-A single blinded randomised control trial

The functional outcomes of adult mandibular condylar fractures with open surgical techniques versus closed reduction modalities-A single blinded randomised control trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001487505
Enrollment
34
Registered
2024-12-20
Start date
2024-12-30
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There are two treatment options for management of condylar fracture i.e. open surgery and closed treatment. Traditionally the conservative management with or without maxillomandibular fixation (MMF) has been the recommended course of care. There are better functional outcomes with surgical techniques than closed methods. Due to possible complications with open surgical methods this option is reserved for severe trauma cases for better functional outcomes. This clinical trial aims to address significant gaps in the current understanding of treatment options for mandibular condylar fractures, ultimately enhancing patient care and outcomes in oral and maxillofacial surgery. The main objective of this randomized control trial is to compare the different functional outcomes in the form of mouth opening, occlusion and pain by open surgical techniques versus closed reduction techniques with or without MMF of condylar fractures.

Interventions

The open reduction group’s treatment will be performed through a 3-cm preauricular incision or hind’s approach. For preauricular incision dissection proceeded in the space between ear cartilage and superficial temporal vessels to safely approach the zygomatic arch until the anterior border of the zygomatic eminence is met. The joint capsule will be opened, and medial displaced fracture segment will be reduced back to the glenoid fossa with the preservation of the attachment of lateral pterygoid

The open reduction group’s treatment will be performed through a 3-cm preauricular incision or hind’s approach. For preauricular incision dissection proceeded in the space between ear cartilage and superficial temporal vessels to safely approach the zygomatic arch until the anterior border of the zygomatic eminence is met. The joint capsule will be opened, and medial displaced fracture segment will be reduced back to the glenoid fossa with the preservation of the attachment of lateral pterygoid muscle and the cartilaginous surface. For hinds approach a vertical incision will be placed through the skin and subcutaneous tissue extending 0.5 cm below the ear lobe towards the angle of the mandible and 1cm posterior and parallel to the posterior border of the mandible. We will go through either trans parotid or retro parotid approach. After subcutaneous dissection the superficial musculoaponeurotic system (SMAS) layer will be incised vertically. Blunt dissection done either within the parotid gland or behind the gland parallel to the facial nerve will be done. Upon reaching the posterior border pterygomasseteric sling will be incised. Mandible will be exposed. If there is sufficient space for placement of a plating system, we will use a semirigid fixation with 2 titanium miniplate (Shangai Haqsun medical instruments) for condylar head fractures one along the posterior border and another anterior medially placed . The occlusion and Temperomandibular joint mobility will be evaluated. Displaced discs will be reduced if found, and finally the joint capsule will be repaired. All concomitant mandible and maxillary fractures will also be treated by open reduction and rigid fixation by rigid plating systems at the same time. After the operation, all patients will receive intermaxillary fixation (IMF) via eyelet wiring to maintain occlusion. The period of IMF ranged from 2 to 6 weeks according to the patients’ occlusion condition. All patients will adopt a liquid diet for 1 week, followed by a soft diet in subsequent month after the operation. Both surgical procedures will take up to 3 hours. The surgery will be performed by one maxillofacial surgeon. After surgery the record of the surgery/ procedure will be made with patient record ID in hospital management information system (HMIS) for postop follow-up. There will be no follow-up surgeries. The open surgical group will receive post op physiotherapy with wooden spatulas at 4 weeks postoperatively. the postoperative physiotherapy will involve wooden spatula sticks kept between upper and lower teeth for 10 mins repeated 3 to 4 times a day increasing one spatula per day.

Sponsors

Sehath Sahuluth Card, Lady Reading Hospital Medical Teaching Institute Peshawar
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult population of age 18 years and above of all genders, ethnicities and geographical areas with traumatic bone condylar fracture will be included in this trial

Exclusion criteria

Patients with firearm injury of the condylar region, underlying pathological bone diseases and recurrent fractures of condyles will not be included in this trial.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026