Comparison of Double Y-shaped Plates and Lag Screws in Fixation of Anterior Mandibular Fractures

Not Applicable

Completed

• Conditions: Mandibular Fractures
• Interventions: Device: double Y-shaped plates; Device: Lag Screws

• Registration Number: NCT04396054
• Lead Sponsor: Lydia Nabil

Brief Summary

This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, to compare Double Y-shaped plates and Lag Screws in fracture fixation from clinical and radiographic perspectives.

Detailed Description

This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, selected from those admitted to the Emergency Department of Alexandria University Hospital. Ethical approval for the study was obtained from the regional Ethical Review Board of the Faculty of Dentistry, Alexandria University. A written informed consent was signed by patients before the operation.

Patients were divided equally into two groups, each consisting of eight patients. Assignment of each patient into one of either group was done using computer random numbers.

Group 1: underwent open reduction and internal fixation using two lag screws. Group 2: underwent open reduction and internal fixation using double Y-shaped plates.

Study Timeline

• Study Start: 2019-09-03
• Primary Completion: 2020-02-20
• Study Completion: 2020-02-20
• Status Verified: 2020-05
• Study First Submitted: 2020-05-09
• Study First Submitted QC: 2020-05-15
• Last Update Submitted: 2020-05-15
• Study First Posted: 2020-05-20
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

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

Inclusion Criteria

• Patients of both genders
• with age ranging from 25 to 45 years,
• suffering from anterior fractures of the mandible (symphyseal or parasymphyseal)

Exclusion Criteria

• old fractures,
• infected fractures
• comminuted fractures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double Y-shaped plates	double Y-shaped plates	Group 2: underwent open reduction and internal fixation using double Y-shaped plates.
Lag Screws	Lag Screws	Group 1: underwent open reduction and internal fixation using two lag screws.

Primary Outcome Measures

Name	Time	Method
progress of fracture healing in the postoperative period	after 6 months	Measurement of bone density in the fracture line using CBCT at 6 points and calculation of mean bone density
Sensory nerve function using dental probe to assess sensory changes along mental nerve distribution and comparing it to the contralateral side	up to 6 months	Detection of nerve injury by examining sensory nerve function using dental probe to assess sensory changes along mental nerve distribution and comparing it to the contralateral side

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Alexandria, Egypt