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NCT Number: NCT06939010

3D Interlocking Miniplates in Fixation of Mandibular Fractures in the Mental Foramen Region: A Split-mouth Study

the study aims to compare 3D Interlocking miniplates with conventional miniplates in management of mandibular parasymphyseal fractures both clinically and radiographically.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, 21523, Egypt

About this study

A total of 12 patients with recent bilateral parasymphyseal mandibular fractures were treated with 3D Interlocking miniplates on one side and with conventional two miniplates in the other side. Clinical evaluations were carried at multiple intervals up to 6 weeks postoperatively, with radiographic assessments performed immediately after surgery and at 12 weeks to measure mean bone density at the fracture line

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with recent bilateral mandibular fracture located in the mental foramina region.
  • adults without gender predilection who agreed to follow-up,
  • fractures requiring open reduction and internal fixation, and
  • those medically fit for general anesthesia were included

Exclusion criteria

  • medically compromised patients,
  • fractures with infection,
  • pathological or old fractures,
  • completely edentulous patients,
  • comminuted fractures

Treatment and study plan

3d-interlocking miniplate

Device

3d-interlocking miniplate

conventional miniplates

Device

double miniplates in the conventional configuration

Primary outcomes

  1. Radiographic evaluation for the assessment of mean bone density at the fracture line

    Time frame: 12 weeks

    Mean bone density at the fracture line was assessed using Cone-Beam Computed Tomography (CBCT) scan in Hounsfield Units (HU)

Secondary outcomes

  1. Clinical evaluation for Intra-fragmentary mobility

    Time frame: 6 weeks

    Intra-fragmentary mobility was evaluated by bimanual palpation at the fracture site

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

3D Interlocking Miniplates Versus Conventional Miniplates in Fixation of Mandibular Fractures in the Mental Foramen Region: A Split-mouth Study

Acronym: Interlocking

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 22, 2025
Registry last updated
Apr 22, 2025

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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