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

NCT07736430 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-07-30

No results posted yet for this study

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.

Conditions

  • Mandibular Fractures
  • Symphysis Fractures
  • Parasymphysis Fractures

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.

Sponsors & Collaborators

  • Suez Canal University

    lead OTHER

Principal Investigators

  • Mohamed Said Hamed, Professor · Professor of Oral and Maxillofacial Surgery - Faculty of Dentistry - Suez Canal University

  • Ahmed Abdelmohsen Younis, Associate Professor · Associate Professor of Oral and Maxillofacial Surgery - Faculty of Dentistry - Suez Canal University

  • Mohamed Abdelnaby, B.S.D · Resident Zagazig University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-11
Primary Completion
2026-04-12
Completion
2026-05-02

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07736430 on ClinicalTrials.gov