Inter Flex Three Dimensional Plate in Management of Mandibular Fracture RCT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-12-03

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Mandibular Fracture Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.).

Group Type EXPERIMENTAL

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

Intervention Type 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 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.).

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No