Evaluate and compare bite force and chewing efficiency in patients with unilateral subcondyle fractures treated either surgically or non-surgically using bite scan and jaw tracker

Phase 3

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2025/06/089229
• Lead Sponsor: Rudramurthe.G

Brief Summary

Mandibular fracture is one of the most common fractures in maxillofacial trauma. They account for around 45% of maxillofacial injuries, of which condylar fractures form a large proportion, contributing to between 17.5% and 52% of mandibular fractures .  Subcondylar fractures comprise 25% – 35% of all mandibular fractures The most common cause of mandibular condylar fracture is road traffic accidents followed by assault, stumbling, sports injuries, falls from height, and industrial accidents and sports injuries . Individuals sustaining condylar fractures present with a wide variety of clinical symptoms. In unilateral condylar fracture, there is ipsilateral gagging of occlusion, contralateral side open bite, midline deviation to the ipsilateral side while opening the mouth, pain, and tenderness on the preauricular region on the same side. In bilateral condylar fracture, loss of vertical height results in an anterior open bite with posterior gagging and pain in the preauricular region bilaterally. Limited mandibular movements such as maximal mouth opening, laterotrusive movement, and protrusive movement .

Bite force in patients with symptoms of dysfunction of the masticatory system is lower than in healthy people and increases as the symptoms disappear . The mainstay in diagnosis includes clinical symptoms followed by two-dimensional radiographs such as Orthopantomogram and Postero-anterior skull view. However, the gold standard in diagnosis and deciding treatment modality is computed tomography .

The treatment modalities advocated for the sub-condyle fracture are the non-operative treatment and operative treatment. Non-operative or conservative treatment aims to produce a bony union where there are no displacement or minimally displaced fracture segments, in case of dislocation of fracture condyle, to produce an acceptable functional pseudoarthrosis by re-education of neuromuscular pathways. The patient is treated by conservative intermaxillary for 2 to 3 weeks followed by active jaw movement exercises. Operative treatment is done by open reduction and internal fixation of the fracture with mini bone plates and screws.

Efficient evaluation of dental occlusion and masticatory function can bring relevant information to decide on the type of treatment to be performed/indicated . Closed treatment relies on the plasticity of the condyle head during recovery, whereas open treatment is challenging and risks facial nerve injury. Based on what has been previously exposed, there is the need to search, specifically, for muscle functioning standards and bite force of the oral-motor system of patients with mandibular unilateral sub-condyle fracture, aiming to guide the therapeutic approach and establish parameters to determine the Functional pathology prognosis.

The objective of the present study is to measure and compare the bite force using T-scan and  3D mandibular border movements using jaw tracker after the management of unilateral subcondyle fracture of the mandible with either ORIF or conservative management.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-07
• Last Update Posted: 2025-06-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Patients having unilateral sub-condyle fracture of the mandible Patients who give informed written consent.

Exclusion Criteria

• 1.Panfacial fractures patients 2.Pregnant patient.
• 3.Immunocompromised patient.
• 4.Patients with active or chronic infection with respect to preauricular region 5.Patients with metabolic diseases 6.The patient with TMJ dysfunction.
• 7.Patient with connective tissue disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bite force- computerized occlusion analysis system.	Baseline (Pre-op), 1 month, 3 months, and 6 months
Mandibular movements - jaw tracker	Baseline (Pre-op), 1 month, 3 months, and 6 months

Secondary Outcome Measures

Name	Time	Method
Functional occulsion -Yes/No	Temporomandibular joint pain- Yes/No

Trial Locations

Locations (1)

All India Institute of Medical Sciences, New Delhi; 🇮🇳 West, DELHI, India

All India Institute of Medical Sciences, New Delhi

🇮🇳West, DELHI, India

Dr Rudramurthe G

Principal investigator

09597109605

rudramurthe@gmail.com