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Clinical Trials/NCT07736430
NCT07736430CompletedNot Applicable

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

Suez Canal University1 site in 1 country20 target enrollmentStarted: June 11, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Radiographic Bone Density

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Adult patients aged 18 to 55 years old.
  • Adult patients of either gender.
  • Patients who are free from any systemic disease (ASA I).
  • Patients suffering from recent, simple and single symphyseal or parasymphyseal mandibular fractures.
  • Unfavorable fractures requiring open reduction and internal fixation.
  • Patients willing to attend all postoperative follow-up visits.

Exclusion Criteria

  • Pregnant or lactating women.
  • Patients with associated maxillofacial injuries that may interfere with study outcomes.
  • Patients with comminuted mandibular fractures.
  • Patients with infected fractures.
  • Patients with pathological fractures.
  • Previously failed fixation of symphyseal or parasymphyseal fractures.

Outcomes

Primary Outcomes

Radiographic Bone Density

Time Frame: Preoperative, immediately postoperative and after 6 months

Bone density at the fracture site was measured in Hounsfield Units (HU) on multislice CT using standardized regions of interest to evaluate osseous healing.

Wound Healing

Time Frame: Day 1, Day 7, and Day 14

Wound healing was assessed clinically using the Southampton Wound Assessment Scale, which evaluates postoperative wound healing based on the presence and severity of normal healing, erythema, bruising, discharge, wound dehiscence, and infection. Higher grades indicate poorer wound healing.

Secondary Outcomes

  • Postoperative Pain(Day 1, Day 7, and Day 14)
  • Postoperative Edema(Day 1, Day 7, and Day 14)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed abdelnaby

Principal Investigator

Suez Canal University

Study Sites (1)

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