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

NCT07590401 | Completed

• 1 other identifier: 1058-04/2025
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mandibular Fracture

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• change in Inter-fragmentary Mobility

  up to 6 weeks

• change in Wound Evaluation

  up to 6 weeks

• adequacy of fracture line reduction

  6 weeks

Study Arms (2)

3D plates

EXPERIMENTAL

Other: Modified 3D Rectangular Grid plate

Conventional plates

ACTIVE COMPARATOR

Other: Two conventional miniplates

Interventions

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.

3D plates

Two conventional miniplates OTHER

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

Conventional plates

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

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

Alexandria, Azarita, 00203, Egypt

Location

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 15, 2026
• Study Start: March 2, 2025
• Primary Completion: February 7, 2026
• Study Completion: February 7, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

EG (1)