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

NCT07736430 | Completed

• 1 other identifier: 968/2025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Mandibular Fractures; Symphysis Fractures; Parasymphysis Fractures

Keywords

Anterior mandibular fracture; Parasymphysis fracture; Symphysis fracture; Pin Buckle bone plate; Conventional miniplate; Internal fixation; Maxillofacial trauma; Bone plate; Computed tomography; Randomized clinical trial; Open reduction and internal fixation

Outcome Measures

Primary Outcomes (2)

• Radiographic Bone Density

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

  Preoperative, immediately postoperative and after 6 months

• Wound Healing

  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.

  Day 1, Day 7, and Day 14

Secondary Outcomes (2)

• Postoperative Pain

  Day 1, Day 7, and Day 14

• Postoperative Edema

  Day 1, Day 7, and Day 14

Study Arms (2)

Pin Buckle Bone Plate

EXPERIMENTAL

Participants underwent open reduction and internal fixation of anterior mandibular (symphysis or parasymphysis) fractures using the Pin Buckle bone plate. Clinical and radiographic outcomes were evaluated during the postoperative follow-up period.

Device: Pin Buckle Bone Plate

Conventional Two-Miniplate Fixation

ACTIVE COMPARATOR

Participants underwent open reduction and internal fixation of anterior mandibular (symphysis or parasymphysis) fractures using conventional titanium two-miniplate fixation according to Champy's principles. Clinical and radiographic outcomes were evaluated during the postoperative follow-up period.

Device: Conventional Titanium Miniplates

Interventions

Pin Buckle Bone Plate DEVICE

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

Pin Buckle Bone Plate

Conventional Titanium Miniplates DEVICE

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

Conventional Two-Miniplate Fixation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University, Faculty of Dentistry

Ismailia, Egypt

Location

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Officials

• Mohamed Said Hamed, Professor

  Professor of Oral and Maxillofacial Surgery - Faculty of Dentistry - Suez Canal University

  STUDY CHAIR

• Ahmed Abdelmohsen Younis, Associate Professor

  Associate Professor of Oral and Maxillofacial Surgery - Faculty of Dentistry - Suez Canal University

  STUDY DIRECTOR

• Mohamed Abdelnaby, B.S.D

  Resident Zagazig University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomly assigned in a 1:1 ratio to receive fracture fixation using either the Pin Buckle bone plate (study group) or conventional two-miniplate fixation (control group). Outcomes were compared between the two parallel groups during the postoperative follow-up period.

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: July 30, 2026
• Study Start: June 11, 2025
• Primary Completion: April 12, 2026
• Study Completion: May 2, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)