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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04396054

Enrollment

Registered

2020-05-20

Start date

2019-09-03

Completion date

2020-02-20

Last updated

2020-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandibular Fractures

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.

Interventions

DEVICELag Screws

Method of internal fixation

DEVICEdouble Y-shaped plates

Method of internal fixation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

25 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026