Inter Flex Three Dimensional Plate in Management of Mandibular Fracture RCT

January 20, 2026 updated by: Suez Canal University

Evaluation of the Efficacy of Custom-Made Inter-flex Three-Dimensional Plate in Treatment of Mandibular Fracture A Randomized Controlled Clinical Trial

The goal of this clinical trial is to learn if The use of a 3D-designed Inter-flex plate will achieve safe and desirable anatomical & functional restoration with reduced operative time in mandibular fracture,

  • Improvement of occlusal and inter-cuspal relation in addition to stabilized intra-fragmentary mobility,
  • Offer greatest resistance to displacement
  • shows most favorable biomechanical behavior

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Mandibular fractures most commonly accompany facial trauma, with nearly half of the patients requiring surgical repair. The treatment of fractures prioritizes the restoration of functionality through The realignment of fractured segments. Conventional methods, such as titanium plates, have been employed for this purpose; however, certain limitations have been observed, such as there is a chance of potential infection and mal-union in mandibular fracture site. Leading to the development of patient specific plates. Furthermore, recent advancements in digital technology in Dentistry enable creation of virtual models and simulations of surgical Procedures. Aim: Is to evaluate the effect of custom-made Inter-flex three dimensional plate vs conventional ready-made Titanium plates in Management of Mandibular Fracture Methodology: This study will be conducted on 20 sites with mandibular fracture in patients. The sites of fracture will be divided into two groups (Group I and Group II) randomly and equally via www.randomizer.org Group I: site with mandibular fracture will be treated with custom made Inter-flex three dimensional plate in site of mandibular fracture, Group II: site with mandibular fracture will be treated with a ready-made Titanium plates in site of mandibular fracture. The postoperative clinical evaluation included presence of infection, stability of the mandibular lower border, state of occlusion, maximal mouth opening. Postoperative radiographic examinations to evaluate the accuracy of reduction and bony union using postoperative c.t 24hour and 3 months by measuring the inter-fragmentary gap and the Intergonial distance.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 2211
        • Recruiting
        • Mataria Teaching Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients who are suffering from recent, uninfected, and minimally displaced or unfavorable mandibular fractures
  2. Adult patients with no gender predilection that agreed to present for follow-up visits for minimum postoperative period of immediate,3 months,6 months.
  3. A fracture that demands open reduction and internal fixation
  4. Patients under ASA-1 category

Exclusion Criteria:

  1. Comminuted, infected mandibular fracture.
  2. Pediatric patients below 4 years old and geriatric patients with completely edentulous mouth.
  3. Patient with osteoporosis
  4. Medical compromised patient (Poorly controlled DM or HTN, COPD, morbid obesity (BMI ≥40), Recent (<3 months) MI, ongoing cardiac ischemia or severe valve dysfunction, severe reduction of ejection fraction, shock, sepsis, undergoing regularly scheduled dialysis, history (>3 months)
  5. Fractures in completely edentulous patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I: site with mandibular fracture will be treated with custom made Inter-flex three dimensional
site with mandibular fracture will be reduced and fixation will be done .visibility using custom made Inter-flex three dimensional plate plates in Group I and fixation using custom made Inter-flex three dimensional according to champ's lines of osteo-synthesis in Group I. closure of the surgical field with vicryl suture material (90% glycolide and 10% L-lactide: Ethicon part of Johnson & Johnson Int, US.).
Procedure: Group I :site with mandibular fracture will be treated with custom made Inter-flex three dimensional plate in site of mandibular fracture
site with mandibular fracture will be reduced and fixation will be done .visibility using custom made Inter-flex three dimensional plate plates in Group I and fixation using custom made Inter-flex three dimensional according to champ's lines of osteo-synthesis in Group I. closure of the surgical field with vicryl suture material (90% glycolide and 10% L-lactide: Ethicon part of Johnson & Johnson Int, US.).
No Intervention: Group II: site with mandibular fracture will be treated with a ready-made Titanium plates in site of
site with mandibular fracture will be reduced and fixation will be done .visibility using conventional double-mini plates in Group II and fixation using 2 mini-plates according to champ's lines of osteo-synthesis in Group II.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mobility of fracture segments
Time Frame: 24 hour after surgery

assessed through bimanual digital manipulation

  • Stable >> no movement of fragments.
  • Nonstable >> presence of movement.
24 hour after surgery
State of occlusion
Time Frame: after 24 hours and after 3 months of surgery
will be assessed by asking the patient to bite in maximum intercuspation at each follow-up (intact/deranged) also by recording molar relation as (satisfactory or deranged).
after 24 hours and after 3 months of surgery
Radiographic evaluation
Time Frame: 24 hour after surgery and after 3 months
  • The linear inter-fragmentary gap between the fractured segments in mm
  • Intergonial distance was measured between the most inferior, lateral, and posterior points of the mandible bilaterally as determined on CT in mm.
24 hour after surgery and after 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suez Canal University

Investigators

  • Study Director: Mohamed Ah Elsholukamy, Professor, Suez Canal University
  • Study Director: Mohamed Na Gad Elhaq, lecturer, Suez Canal University
  • Study Director: Maurice Fe khalil, consultant, Mataria Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Saad, A., Khalil, A. F., & El-Mahallawy, Y. (2025). INTERFLEX PLATE VERSUS CONVENTIONAL MINIPLATES IN THE MANAGEMENT OF ANTERIOR MANDIBULAR FRACTURES. a RANDOMIZED CONTROLLED CLINICAL TRIAL. Alexandria Dental Journal, 0(0), 0. https://doi.org/10.21608/adjalexu.2025.344361.1572

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 3, 2026

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 23, 2025

First Posted (Actual)

December 4, 2025

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/1012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

because these are patient data that cant be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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