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NCT Number: NCT07736430

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

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.

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Key information

Conditions

Mandibular Fractures Craniocerebral Trauma Facial Injuries Fractures, Bone Jaw Fractures Maxillofacial Injuries Nervous System Diseases Parasymphysis Fractures Skull Fractures Symphysis Fractures Trauma, Nervous System Wounds and Injuries

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez Canal University, Faculty of Dentistry

Ismailia, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pin Buckle Bone Plate

Device

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

Conventional Titanium Miniplates

Device

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

Primary outcomes

  1. 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.

  2. 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

  1. Postoperative Pain

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

    Pain intensity was assessed using a 10-cm Visual Analogue Scale (VAS), where 0 indicated no pain and 10 indicated the worst pain imaginable.

  2. Postoperative Edema

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

    Facial edema was evaluated clinically by visual inspection and palpation and categorized as none, low-grade, intermediate-grade, or high-grade according to the severity of facial swelling.

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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