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

Mandibular Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04396054
• Other study ID #: UAlexandriaDentSurg1
• Status: Completed
• Phase: N/A
• Start date: September 3, 2019
• Est. completion date: February 20, 2020

Study information

• Verified date: May 2020
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 20, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Mandibular Fractures

Intervention

Device:
• Lag Screws
Method of internal fixation
• double Y-shaped plates
Method of internal fixation

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Lydia Nabil

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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