Inter Flex Three Dimensional Plate in Management of Mandibular Fracture RCT

NCT07263893 | Recruiting DMC

• 1 other identifier: 2025/1012
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mandibular Fracture Treatment

Keywords

INTER-FLEX 3D PLATE; mandibular fractures; radiographic assesment; time of surgery; healing

Outcome Measures

Primary Outcomes (3)

• Radiographic evaluation

  * 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

• Mobility of fracture segments

  assessed through bimanual digital manipulation * Stable \>\> no movement of fragments. * Nonstable \>\> presence of movement.

  24 hour after surgery

• State of occlusion

  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

Study Arms (2)

Group I: site with mandibular fracture will be treated with custom made Inter-flex three dimensional

EXPERIMENTAL

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

Group II: site with mandibular fracture will be treated with a ready-made Titanium plates in site of

NO INTERVENTION

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.

Interventions

Group I :site with mandibular fracture will be treated with custom made Inter-flex three dimensional plate in site of mandibular fracture PROCEDURE

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.).

Group I: site with mandibular fracture will be treated with custom made Inter-flex three dimensional

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Comminuted, infected mandibular fracture.
• Pediatric patients below 4 years old and geriatric patients with completely edentulous mouth.
• Patient with osteoporosis
• 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)
• Fractures in completely edentulous patients

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Mataria Teaching Hospital

Cairo, 2211, Egypt

RECRUITING

Related Publications (1)

• 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

  RESULT

Related Links

• INTERFLEX PLATE VERSUS CONVENTIONAL MINIPLATES IN THE MANAGEMENT OF ANTERIOR MANDIBULAR FRACTURES. A RANDOMIZED CONTROLLED CLINICAL TRIAL

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 Officials

• 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

  STUDY DIRECTOR

Central Study Contacts

abdelkader hegazy, bachelor

CONTACT

+201119980050; abdokita35@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Brand name thickness Composition Company software Customized CAD CAM milled plates 1mm Titanium plate Arab engineers corporation blender Screws 2mm Titanium screw Arab engineers corporation blender II- Methods: 1. Study Design: Randomized clinical study via www.randomizer.org 2. Study Setting: This study will be conducted on twenty mandibular fracture sites 3. Study population and sampling: Patients will be selected from the outpatient clinic of the Oral and Maxillofacial Surgery department in the Faculty of Dentistry, Suez Canal University also from emergency room of Mataria Teaching Hospital. All patients will be informed with all the details of the surgical procedures, complications and the whole study schedule. Then, each patient will sign an informed consent. Patients participating in the current study will have to fulfill the following eligibility criteria: Inclusion criteria: (Zhao et al., 2018) 1-Patients who are suffering from re

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 4, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 3, 2026
• Last Updated: January 22, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)