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

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

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.

Study Overview

• Status: Completed
• Conditions: Mandibular Fractures
• Intervention / Treatment: Device: 2.0 miniplates; Device: 2.3 high profile miniplates; Device: 3D miniplates

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12566
    • October 6U

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients who had suffered from a recent mandibular fractures in the symphyseal or parasymphyseal region which required Open Reduction with Internal Fixation (ORIF)

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group (I); ORIF was done using two 2.0 miniplates	Device: 2.0 miniplates; 2.0 miniplates
Group II; ORIF was done using 2.3 high profile miniplates	Device: 2.3 high profile miniplates; 2.3 high profile miniplates
Group III; ORIF was done using 3D miniplates.	Device: 3D miniplates; 3D miniplates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery Time	measure the time of surgery from incision till closure with minutes	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complication	record the surgical complication operative and postoperative	6 months
fracture stability	measure fracture stability from radiographs	6 months

Collaborators and Investigators

• Sponsor: October 6 University
• Investigators: Principal Investigator: Nermine Ramadan Mahmoud, PhD, Associated Professor of oral and maxillofacial surgery, Oral Surgery Department

Publications and helpful links

General Publications

• Hu W, Agrawal M, Thadani S, Mukul SK, Sood R, Patel A, Dhanak R, Tailor S. Comparative evaluation of a single 2.0-mm AO locking reconstruction plate with conventional miniplate osteosynthesis for treatment of linear non-comminuted fractures of symphysis and parasymphsis region of the mandible. J Stomatol Oral Maxillofac Surg. 2019 Feb;120(1):11-15. doi: 10.1016/j.jormas.2018.10.002. Epub 2018 Oct 26.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: internal fixation; 3D miniplate; parasymphyseal; mandibular fracture; miniplates
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Fractures, Bone; Mandibular Fractures
• Other Study ID Numbers: Plating Techniques 2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No