Sagittal Split Plate Versus Two Miniplates in the Treatment of Mandibular Angle Fractures

Not Applicable

Recruiting

• Conditions: Mandible Fracture

• Registration Number: NCT07103590
• Lead Sponsor: Alexandria University

Brief Summary

Mandibular fractures are the second most common maxillofacial fracture after nasal bone fracture. As a result, a lot of research work has gone into improving treatment methods for these fractures including, reduction of immobilization period and enhancement of rigid fixation. One of these modalities is the use of Sagittal Split plate at the angle of the mandible.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-15
• Study Start: 2025-07-16
• Study First Submitted QC: 2025-07-29
• Last Update Submitted: 2025-07-29
• Study First Posted: 2025-08-05
• Last Update Posted: 2025-08-05
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Patients suffering from recent, uninfected angle mandibular fracture.
• Fracture that demands open reduction and internal fixation.

Exclusion Criteria

• Medically compromised patients contradicting the operation.
• Existence of infection at the fracture line.
• Pathological fracture.
• An old fracture.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in pain scores	baseline, 24 hours, 1 week, and 6 weeks	Will be assessed through a 10-point Visual Analogue Scale (VAS) (34). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe).
Change in Maximal Inter-Incisal Mouth	baseline, 24 hours, 1 week, and 6 weeks	Using a millimeter ruler to measure maximal inter-incisal mouth opening

Secondary Outcome Measures

Name	Time	Method
postoperative infection	24 hours, 1 week, and 6 weeks	observation for any manifestations of wound healing disturbance
change in bone density	baseline and 12 weeks	Immediate CT (T0) scan will be done and then another CT (T1) will be taken at 12th week to estimate the mean bone density at the fracture line in comparison with the immediate postoperative scan

Trial Locations

Locations (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt