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Completed

NCT Number: NCT07590401

Modified 3d Rectangular Grid Plate for Fixation of Anterior and Body Mandibular Fractures

Background: Fractures of anterior mandible (symphysis and parasymphysis) make up about 9% to 57%, of mandibular fractures, and body fractures make up about 21%; posing challenges for stabilization due to anatomical constraints. Traditional 3D plates have limitations in this area, leading to the development of Modified 3D Rectangular Grid plates. Studies have shown that these plates offer superior stabilization over larger configurations while maintaining a low profile like miniplates. Additionally, design modifications ensure mental nerve preservation, balancing effective fixation with neurovascular safety.

Aim of this study: To evaluate the use of Modified 3D Rectangular Grid plates in comparison with conventional mini plates for fixation of mandibular fracture in the anterior and body regions, clinically regarding pain, interfragmentary mobility, maximal inter-incisal opening, wound healing, and sensory nerve evaluation, and radiographically regrading fracture reduction.

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Key information

Conditions

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

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Azarita, 00203, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients suffering from recent fractures at the symphysis, parasymphysis and body regions
  • Adult patients with no gender predilection who agreed to present for follow-up visits
  • A fracture that demands open reduction and internal fixation.
  • The patient medically fit for general anesthesia

Exclusion criteria

  • Patients suffering from recent fractures at the symphysis, parasymphysis and body regions
  • Adult patients with no gender predilection who agreed to present for follow-up visits
  • A fracture that demands open reduction and internal fixation
  • The patient medically fit for general anesthesia

Treatment and study plan

Modified 3D Rectangular Grid plate

Other

The system consists of a lower 1.5-mm rectangular plate and an upper linear plate that interlock through circular recesses and elevations. Each component is 0.75 mm thick at the junction, giving a total thickness of 1.5 mm. After screw fixation, it provides 3D stability similar to standard 3D plates while minimizing risk to the mental nerve.

Two conventional miniplates

Other

conventional mini plates for fixation of mandibular fracture in the anterior and body regions

Primary outcomes

  1. change in maximum mouth opening

    Time frame: up to 6 weeks

    Using a millimetre ruler to measure maximal inter-incisal mouth opening; considered to be adequate if >30 mm and inadequate if <30 mm

  2. change in pain scores

    Time frame: up to 6 weeks

    Will be assessed through a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe

Secondary outcomes

  1. change in Inter-fragmentary Mobility

    Time frame: up to 6 weeks

    The mobility will be assessed by bi-manual palpation across the fracture site.

  2. change in Wound Evaluation

    Time frame: up to 6 weeks

    The sutured wounds will be examined for signs and symptoms of infection uisng modified Landry's index

  3. adequacy of fracture line reduction

    Time frame: 6 weeks

    Whenever alignment of the inferior border of the mandible will be maintained across the fracture line, it will be considered an excellent reduction. If a discrepancy of 1-3 mm will be noted, it will be considered a good reduction. If a discrepancy of 3-5 mm will be noted, it will be labeled as a fair reduction. If the discrepancy will be > 5 mm, it will be considered a poor reduction.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Evaluation of the Use of Modified 3d Rectangular Grid Plate for Fixation of Anterior and Body Mandibular Fractures (Randomized Controlled Clinical Trial)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 15, 2026
Registry last updated
May 15, 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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