Inter Flex Three Dimensional Plate in Management of Mandibular Fracture RCT

Official title

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

Overview

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

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.

Interventions

• 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.).

Primary outcome measures

• Radiographic evaluation [Time frame: 24 hour after surgery and after 3 months]
• Mobility of fracture segments [Time frame: 24 hour after surgery]
• State of occlusion [Time frame: after 24 hours and after 3 months of surgery]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Mataria Teaching Hospital — Cairo

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

Identifiers

NCT: NCT07263893 · 2025/1012

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗