Inter Flex Three Dimensional Plate in Management of Mandibular Fracture RCT
ConditionMandibular Fracture Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorSuez Canal University
About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Group I :site with mandibular fracture will be treated with custom made Inter-flex three dimensional plate in site of mandibular fracture
Procedure/Surgerysite 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.).
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Group I: site with mandibular fracture will be treated with custom made Inter-flex three dimensionalExperimental treatment 1 intervention
Group B: Group II: site with mandibular fracture will be treated with a ready-made Titanium plates in site ofNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
24 hour after surgery and after 3 months2
Mobility of fracture segments
assessed through bimanual digital manipulation * Stable \>\> no movement of fragments. * Nonstable \>\> presence of movement.
Time frame
24 hour after surgery3
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).
Time frame
after 24 hours and after 3 months of surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov