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COMPLETED
NCT07736430
NA

Evaluation of Pin Buckle Bone Plates for Management of Anterior Mandibular Fractures

Sponsor: Suez Canal University

View on ClinicalTrials.gov

Summary

This randomized clinical study aims to evaluate the clinical and radiographic outcomes of a novel Pin Buckle bone plate compared with conventional two-miniplate fixation for the management of anterior mandibular (symphysis and parasymphysis) fractures. Twenty adult patients requiring open reduction and internal fixation will be randomly allocated into two equal groups. The study group will receive fixation using the Pin Buckle bone plate, while the control group will be treated using conventional titanium miniplates. Clinical outcomes including pain, edema, wound healing, and postoperative complications will be evaluated during the postoperative follow-up period. Radiographic assessment using computed tomography (CT) will be performed immediately after surgery and at 6 months to evaluate bone density. The study seeks to determine whether the Pin Buckle bone plate provides improved postoperative healing and functional outcomes compared with conventional miniplate fixation.

Official title: Clinical and Radiographic Evaluation of Pin Buckle Bone Plates for Management of Anterior Mandibular Fractures: A Randomized Study

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-06-11

Completion Date

2026-05-02

Last Updated

2026-07-30

Healthy Volunteers

Yes

Interventions

DEVICE

Pin Buckle Bone Plate

A titanium Pin Buckle bone plate used for internal fixation of anterior mandibular fractures following open reduction.

DEVICE

Conventional Titanium Miniplates

Conventional titanium miniplates used for internal fixation of anterior mandibular fractures following open reduction according to Champy's principles.

Locations (1)

Suez Canal University, Faculty of Dentistry

Ismailia, Egypt