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

Study Overview
=================
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.

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

Conditions
-----------------
Mandibular Fractures

Intervention / Treatment
-----------------
* Device: Lag Screws
* Device: double Y-shaped plates


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lag Screws<br>Group 1: underwent open reduction and internal fixation using two lag screws. | Device: Lag Screws<br>* Method of internal fixation<br>|
| Active Comparator: Double Y-shaped plates<br>Group 2: underwent open reduction and internal fixation using double Y-shaped plates. | Device: double Y-shaped plates<br>* Method of internal fixation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progress of fracture healing in the postoperative period | Measurement of bone density in the fracture line using CBCT at 6 points and calculation of mean bone density | after 6 months | 
| Sensory nerve function using dental probe to assess sensory changes along mental nerve distribution and comparing it to the contralateral side | 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 | up to 6 months |