Trials Sponsors Conditions Drugs Pricing

Conditions

Mandibular Fracture Treatment

Keywords

mandibular fractureopen reductionz-shaped plateconventional bone plates

Outcome Measures

Primary Outcomes (2)

Radiographic evaluation (Bone density ratio at fracture line ) measured using orthopantomograms (OPGs) by ImageJ software.
Radiographic evaluation using orthopantomograms (OPGs) is performed immediately postoperatively, at 1 month and 4 months. To assess bone density along the fracture line, a densitometric analysis was conducted using the ImageJ system. Digital images are analyzed using ImageJ software. The mean gray value of a region of interest (ROI) drawn along the entire length of the fracture line was calculated. This gray value represents the relative bone density within the fracture site. Range: 0.0 - 1.0 (unitless ratio). Higher values indicate greater bone density and better healing
within 1week postoperative, 1month, 4month
Postoperative pain assessed using the Visual Analog Scale (VAS)
postoperative pain assessed using the Visual Analog Scale (VAS). Range: 0 (no pain) - 10 (worst imaginable pain). Higher scores indicate worse pain
day 1 , day 3, and 1week postoperative

Secondary Outcomes (1)

Clinical fracture stability evaluated by manual mobility test and tenderness on palpation.
1 week postoperative,1month, 3 months, 6 months

Study Arms (2)

z-plate

EXPERIMENTAL

mandibular fracture will be reduced and fixed with Z shaped bone plate

Procedure: open reduction and internal fixation with bone plateProcedure: z-plates.

conventional Miniplate

ACTIVE COMPARATOR

mandibular fracture will be reduced and fixed with conventional two miniplates.

Procedure: open reduction and internal fixation with bone plateProcedure: conventional miniplates.

Interventions

open reduction and internal fixation with bone plateProcedure

mandibular fracture were reduced and fixed with bone plates.

conventional Miniplatez-plate

z-plates.Procedure

mandibular fracture were reduced and fixed with z-plate miniplates.

z-plate

Eligibility Criteria

Age19 Years - 50 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Patients who are suffering from recent, uninfected, and minimally displaced or unfavorable fractures at the symphysial or parasymphysis region of the mandible.
Adult patients with no gender predilection that agreed to present for follow-up visits for minimum postoperative period of immediate, month, 3 months,6 months.

Sponsors & Collaborators

Suez Canal University
Otherlead

Study Sites (1)

Suez Canal University hospital, Ismailia

Ismailia, Egypt

MeSH Terms

Conditions

Mandibular Fractures

Interventions

Open Fracture ReductionFracture Fixation, InternalBone Plates

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Study Officials

Mohamed S. Hamed, professor
Oral and Maxillofacial Surgery, Faculty of Dentistry, Suez Canal University
STUDY CHAIR
Mohamed A. Elsholkamy, professor
Oral and Maxillofacial Surgery, Faculty of Dentistry, Suez Canal University
STUDY DIRECTOR
Amr A. Gomaa, associate professor
plastic Surgery, Faculty of medicine, Suez Canal University
STUDY DIRECTOR
Eman M. Eldemardash, assistant lecturer
Oral and Maxillofacial Surgery, Faculty of Dentistry, Suez Canal University
PRINCIPAL INVESTIGATOR

Enrollment

18 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: PRINCIPAL INVESTIGATOR
PI Title: Assistant Lecturer oral and maxillofacial surgery department, Faculty of Dentistry

Study Record Dates

First Submitted

September 4, 2025

First Posted

September 22, 2025

Study Start

January 28, 2024

Actual (reported)

Evaluation of Z-shaped Bone Plates in Management of Mandibular Fractures

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

z-plate

conventional Miniplate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

z-plate

conventional Miniplate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations