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

Mandibular Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06323122
• Other study ID #: Plating Techniques 2023
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2024
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Mandibular Fractures

Intervention

Device:
• 2.0 miniplates
2.0 miniplates
• 2.3 high profile miniplates
2.3 high profile miniplates
• 3D miniplates
3D miniplates

Locations

Country	Name	City	State
Egypt	October 6U	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgery Time	measure the time of surgery from incision till closure with minutes	intraoperative
Secondary	complication	record the surgical complication operative and postoperative	6 months
Secondary	fracture stability	measure fracture stability from radiographs	6 months