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A Study Comparing Two Plates Versus a Single Lambda-Shaped Plate for Treating Lower Jaw Joint Fractures and Improving Jaw Movement and Function

A Randomized Controlled Trial Comparing Lambda Plate Versus Conventional Double-Miniplate Fixation in the Management of Mandibular Subcondylar Fractures - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100012
Enrollment
16
Registered
2026-01-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: S026- Fracture of mandible Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Single 2.0-mm Lambda-shaped plate fixation: Open reduction and internal fixation of unilateral mandibular subcondylar fracture using a single 2.0-mm titanium lambda-shaped plate placed

Sponsors

All India Institute of Medical Sciences (AIIMS), Patna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged eighteen years and above with unilateral displaced mandibular subcondylar fracture indicated for open reduction and internal fixation. Patients who are medically fit for general anesthesia and willing to participate and provide written informed consent.

Exclusion criteria

Exclusion criteria: Patients with bilateral subcondylar fractures or comminuted fractures. Patients with pathological fractures or history of temporomandibular joint ankylosis. Patients with previous mandibular surgery or metabolic bone disease. Medically compromised patients classified as American Society of Anesthesiologists grade three or higher. Patients unwilling to provide informed consent or comply with follow up

Design outcomes

Primary

MeasureTime frame
Maximum Mouth Opening in millimeters,Lateral Mandibular Excursion in millimeters,Mandibular Protrusion in millimeters,Deviation on Mouth Opening measured in millimeters from midlineTimepoint: Pre-op Post-op 2weeks Post-op 1month Post-op 3months Post-op 6months

Secondary

MeasureTime frame
Post operative Occlusal Status categorized as favorable or unfavorable,Time required for plate adaptation & fixation measured in minutes,Radiographic restoration of ramus height measured in millimeters,Post operative complicationsTimepoint: Pre-op Post-op 2weeks Post-op 1month Post-op 3months Post-op 6months

Countries

India

Contacts

Public ContactNaqoosh Haidry

All India Institute of Medical Sciences (AIIMS), Patna

naqoosh.haidry@gmail.com7096843640

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026