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

Lydia Nabil

Status: Completed

Conditions: Mandibular Fractures

Treatments: Device: Lag Screws; Device: double Y-shaped plates

Study type: Interventional

Funder types: Other

Identifiers

NCT04396054

UAlexandriaDentSurg1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Lag Screws

Active Comparator group

Description:

Group 1: underwent open reduction and internal fixation using two lag screws.

Treatment:

Device: Lag Screws

Double Y-shaped plates

Active Comparator group

Description:

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

Treatment:

Device: double Y-shaped plates