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
Qualifiers
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
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
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov