Trials Sponsors Conditions Drugs Pricing

Conditions

Mandibular Fracture

Outcome Measures

Primary Outcomes (3)

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 12 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 12 weeks
change in Neurosensory function
patient was asked about prescence of sensation alteration
up to 12 weeks

Secondary Outcomes (3)

change in Inter-fragmentary Mobility
up to 12 weeks
change in Wound Evaluation
up to12 weeks
adequacy of fracture line reduction
12 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 plateOther

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 miniplatesOther

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

Eligibility Criteria

Age18 Years - 64 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Alexandria University
Otherlead

Study Sites (1)

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

Alexandria, Azarita, 00203, Egypt

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw FracturesMaxillofacial InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesSkull FracturesFractures, BoneWounds and Injuries

Enrollment

22 participants (actual enrollment reported by the registry).

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

May 2, 2025

Actual (reported)

Primary Completion

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (2)

3D plates

Conventional plates

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (2)

3D plates

Conventional plates

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations