Force Measurement, Mandible Fracture
Conditions
Brief summary
Hypothesis The investigators hypothesis that fixation of mandibular angle fractures using a 3D titanium miniplate will provide better occlusal bite force than intraoral fixation using the standard two-plate technique. The investigators expect that this method will facilitate a faster recovery time for participants to regain baseline occlusion force.
Interventions
DEVICETwo Standard Plate Fixation
Fixation using two titanium miniplates. One plate at the inferior border of the mandible with bicortical screws. Second plate \~5 mm above or at the external oblique ridge with monocortical screws.
DEVICE3D Titanium Miniplate (2.0 mm, 8-hole).
Single 2.0 mm 9-hole 3D titanium plate fixed with monocortical screws. Plate contoured with horizontal crossbars perpendicular and vertical struts parallel to fracture line. Screws placed diagonally first.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* • Age from 20 to 50years. * Male . * Patients with mandibular angle fractures.
Exclusion criteria
* • Patients with contraindication to general anesthesia * Patients with comminuted angle fractures. * Patients with relevant systemic diseases contraindicating surgery or affecting bone healing. * Patients with infected condyle and coronoid fractures. * Gun-shot injuries. * Edentulous fractures. * Pathological fractures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occlusal force | first day surgery , second visit 30 days , the last visit 120 days. . | use bite force measurement device . make patient bite to muser the force (, newton unit). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| maximal incisal opening. | first day surgery , second visit 30 days , the last visit 120 days. . | Ask the patient to open their mouth as wide as possible without feeling pain. Using a ruler or caliper, measure the vertical distance between the incisal edge of the upper central incisor and the incisal edge of the lower central incisor |
| Patient satisfaction | first day surgery , second visit 30 days , the last visit 120 days. . | will be measured on a visual analogue scale (VAS) with zero being unsatisfied and ten being satisfied and happy . |
Countries
Egypt
Outcome results
None listed