Patient Specific Three-Dimensional Titanium Plates Versus Conventional Miniplates for Treatment of Mandibular Body Fractures. (Randomized Clinical Trial)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 20
- Primary Endpoint
- Patient Satisfaction measured with visual analogue scale (0-10)
Study Overview
Brief Summary
The aim of the current study is to evaluate and assess the clinical stability and efficacy of patient specific computer guided titanium plates versus the conventional titanium mini plates regarding accurate reduction and fixation of mandibular body fractures, reducing the operating time, achieving precise bone alignment and reducing the plate palpability.
Detailed Description
The study will be conducted on two groups:
Intervention group: patient specific three-dimensional titanium plates CBCT or CT scan will be performed for the patient, the dicom files will be imported into a surgical planning software , plates will then be designed virtually and sent for three-dimensional (3D) printing.
Control group: Conventional miniplates:
In this group two miniplates of titanium Mini-System 2.0 mm will be used. The plate has profile height 1.0 mm whereas the screw length varies according to the site of the plate. According to Champy osteosynthesis lines for fixation of the posterior mandibular fracture ,the first plate will be placed at the inferior border from the buccal side, using bicortical screws engaging the buccal and lingual cortices to achieve rigid fixation, while the second plate will be placed at about 5mm superior to the inferior plate in the subapical region, using monocortical screws engaging only the buccal cortex to avoid injuring the teeth roots.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients with unilateral mandibular body fractures, not associated with other mandibular and maxillofacial fractures
Exclusion Criteria
- •Patients with bilateral mandibular fractures
- •Patients with other mandibular or maxillofacial fractures
- •Comminuted fractures
- •Medical problem that may interfere with the procedure such as bleeding disorder and pregnancy.
Arms & Interventions
Control Arm
Conventional titanium miniplates
Intervention: Conventional titanium miniplates (Device)
Intervention arm
Patient specific 3D plates
Intervention: Computer guided patient specific 3D titanium plate (Device)
Outcomes
Primary Outcomes
Patient Satisfaction measured with visual analogue scale (0-10)
Time Frame: Measured immediately after the surgery
patient satisfaction is defined as patient-reported outcome measure while the structures and processes of care can be measured by patient-reported experiences (30). Measured on a visual analogue scale (VAS) (29) of 0-10 ,with zero being unsatisfied and 10 being satisfied. Patient Satisfaction is assessed regarding prescence of pain, occlusal discrepencies and overall patient satisfaction.
Secondary Outcomes
- Plate palpability(0 and 3 months)
- Fracture gap distance(0 and 3 months)
- Occlusal bite force(0 and 3 months)
- Operating time(time of the surgery)
Investigators
Dina Adel
Master degree student
Cairo University