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

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

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.

Study Overview

• Status: Completed
• Conditions: Mandibular Fracture
• Intervention / Treatment: Other: Modified 3D Rectangular Grid plate; Other: Two conventional miniplates

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Azarita
    • Alexandria, Azarita, Egypt, 00203
      • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D plates	Other: Modified 3D Rectangular Grid plate; 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.
Active Comparator: Conventional plates	Other: Two conventional miniplates; conventional mini plates for fixation of mandibular fracture in the anterior and body regions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in maximum mouth opening	Using a millimetre ruler to measure maximal inter-incisal mouth opening; considered to be adequate if >30 mm and inadequate if <30 mm	up to 6 weeks
change in pain scores	Will be assessed through a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe	up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in Inter-fragmentary Mobility	The mobility will be assessed by bi-manual palpation across the fracture site.	up to 6 weeks
change in Wound Evaluation	The sutured wounds will be examined for signs and symptoms of infection uisng modified Landry's index	up to 6 weeks
adequacy of fracture line reduction	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.	6 weeks

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2025
• Primary Completion (Actual): February 7, 2026
• Study Completion (Actual): February 7, 2026

Study Registration Dates

• First Submitted: May 10, 2026
• First Submitted That Met QC Criteria: May 10, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 10, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Fractures, Bone; Craniocerebral Trauma; Trauma, Nervous System; Facial Injuries; Jaw Fractures; Maxillofacial Injuries; Skull Fractures; Mandibular Fractures
• Other Study ID Numbers: 1058-04/2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No