A Comparative Study Between Three Different Plating Techniques in Management of Mandibular Parasymphyseal Fractures.

Completed

• Conditions: Mandibular Fractures
• Interventions: Device: 3D miniplates; Device: 2.0 miniplates; Device: 2.3 high profile miniplates

• Registration Number: NCT06323122
• Lead Sponsor: October 6 University

Brief Summary

The main goal in management of mandibular fractures is to restore the pre-injury form and function, with the least disability and shortest recovery period.

Detailed Description

Currently there are a diversity of metallic hardware used for fixation of jaw fractures. However, the proper selection of the suitable technique is still a matter of debate.

The aim of the current study was to compare between the effect of two miniplates, 2.3 high profile Miniplates and three dimensional (3D) Miniplates for internal fixation treatment of mandibular para-symphyseal fractures.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2023-10-01
• Study Completion: 2023-12-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-20
• Last Update Submitted: 2024-03-20
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients with symphyseal/ parasymphyseal mandibular fracture.
2. Patients presenting within 7 days of trauma.

Read More

Exclusion Criteria

1. Associated fractures that could affect occlusion or dimensions
2. Medically compromised patients who are unfit for management under General Anesthesia
3. Patients with gross infection at the site of fracture
4. Patients not willing to return for follow-up
5. Patients with associated bone pathology

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group III	3D miniplates	ORIF was done using 3D miniplates.
group (I)	2.0 miniplates	ORIF was done using two 2.0 miniplates
Group II	2.3 high profile miniplates	ORIF was done using 2.3 high profile miniplates

Primary Outcome Measures

Name	Time	Method
Surgery Time	intraoperative	measure the time of surgery from incision till closure with minutes

Secondary Outcome Measures

Name	Time	Method
complication	6 months	record the surgical complication operative and postoperative
fracture stability	6 months	measure fracture stability from radiographs

Trial Locations

Locations (1)

October 6U; 🇪🇬 Cairo, Egypt