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Completed

NCT Number: NCT06740292

InterFlex Plate Versus Conventional Miniplates in the Management of Anterior Mandibular Fractures.

the study aims to compare InterFlex plate with conventional miniplates in management of symphyseal mandibular fracture clinically regarding pain, wound healing and postoperative occlusion, and radiographically regrading bone density.

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Key information

Conditions

Anterior Mandibular Fracture

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 18 patients with recent symphyseal mandibular fractures were allocated into two groups. Group A, comprising 9 patients, underwent treatment with the InterFlex plate, while Group B, also consisting of 9 patients, was treated with conventional two miniplates. Clinical evaluations were carried at multiple intervals up to 12 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 anterior mandibular fracture located between the mental foramina.
  • 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

conventional miniplates

Device

conventional miniplates in double configuration

InterFlex plates

Device

InterFlex plates in configuration

Primary outcomes

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

    Time frame: 3 months

    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 pain

    Time frame: six weeks

    Pain was assessed using Visual Analogue Scale (VAS)

Other outcomes

  1. Clinical evaluation for Intra-fragmentary mobility

    Time frame: six 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

InterFlex Plate Versus Conventional Miniplates in the Management of Anterior Mandibular Fractures. a Randomized Controlled Clinical Trial

Acronym: InterFlex

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

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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