Clinical trial NCT03608891: Patient Specific Plates Versus Conventional Miniplates for Treatment of Mandibular Body Fractures
Official title: Patient Specific Three-Dimensional Titanium Plates Versus Conventional Miniplates for Treatment of Mandibular Body Fractures. (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mandibular Fractures
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Satisfaction measured with visual analogue scale (0-10)
timeFrame: Measured immediately after the surgery
Secondary outcomes:
measure: Fracture gap distance
timeFrame: 0 and 3 months
measure: Occlusal bite force
timeFrame: 0 and 3 months
measure: Operating time
timeFrame: time of the surgery
measure: Plate palpability
timeFrame: 0 and 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Mohamed A Farid, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Mohamed A Abd el Rasol, PhD
role: STUDY_CHAIR
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