Sample Size Estimation
Patients with anterior mandibular fractures were selected from the outpatient clinic of oral and maxillofacial surgery department and the surgical procedures were performed under general anesthesia. Sample size was estimated using G-Power version 3.1.9.2 (Faul, Erdfelder, Lang. & Buchner. 2007) (20). A minimal total hypothesized sample size of 15 patients with anterior mandibular fractures was needed.
This study was performed after gaining ethical approval from Research Ethics Committee, Faculty of Dentistry, Alexandria University with the number 0308-1012021. Before starting the study, objectives, risks, and benefits were explained to the patients, and they received both oral and written information about the benefits and risks of the interventions and signed, informed consent was obtained prior to treatment.
The participating patients in this study were chosen according to the following criteria:
Inclusion criteria
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Recent anterior mandibular fractures (within one week).
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Adult patients of both genders (18–50 years old).
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Systematic healthy patients.
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Radiographic evidence of anterior mandibular fracture.
Exclusion criteria
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Medically compromised patients contraindicated for general anesthesia and bone surgery.
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Comminuted fractures.
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Bilateral anterior mandibular fractures.
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Previously treated fractures.
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Pathological fractures and bone diseases.
Plate specifications:
Three-dimensional miniplates were created by connecting two miniplates using vertical crossbars to reduce bending. The quadrangular plate's geometric shape, rather than its length or thickness, increased its stability (thickness 1 mm, length 20 mm, and width 12 mm). Four holes 3D titanium grade 4 miniplates with titanium self-tapping screws in sizes 2 × 8 mm and 2 × 10 mm were used to fix the plates (Fig. 1D).
Preoperative assessment:
Personal, past medical and dental history and chief complaints were taken. General examination, both extra oral and intra oral examinations and radiographic examinations were done. A computed tomography (CT) scan was performed.
Fabrication of 3D printed models
Every patient had a CT scan, and the data was imported into Mimics software (MIMICS). Axial section images were used to define image thresholds, removing all soft tissues, and highlighting bone and dental tissues. Mandibular bone and teeth were also chosen, and a three-dimensional reconstruction of the segmented mandible, as well as dental hard tissue, was created (Fig. 1A, B). The mandibular bone of the healthy side was mirrored to the fracture side by software to rebuild a perfect reduction model (Fig. 1C). The 3D model of the fractured mandible was printed using a 3D printer. Bone fixation 3D plates were pre-modeled and adapted on the three-dimensional printed model, submitted to sterilization, and were utilized during surgery for bone reduction and fixation (Fig. 1D) (21, 22).
Surgical phase
The fracture line was exposed through the standard mandibular vestibular approach. Vasoconstrictor injection was done in the submucosal plane to lessen bleeding during incision and dissection. The lower lip was everted, and an anterior incision was made from canine to canine. A scalpel or electrocautery was used to incise the mucosa. Curvilinear and anteriorly extending into the lip, the incision leaving 10 to 15 mm of mucosa still adhered to the gingiva. (23).
The underlying mentalis muscle fibers were incised sharply in an oblique direction to the mandible. It was crucial to keep the mental nerve out of the way. Maxillo-mandibular fixation was temporarily secured followed by bone reduction into proper anatomical position. The prebent 3D miniplates were fitted the contour of the anatomically repositioned bone fragments following reduction. Except for the anterior region, one layer of closure is sufficient. Three or more deep resorbable sutures must be inserted into the mentalis muscle. Then, a non-resorbable suture is inserted through origin and insertion of each mentalis, followed by another suture in the midline. Following that, a suture was used to seal the mucosa (Fig. 2).
Postoperative phase
Early postoperative care and Postoperative medication
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Antibiotic (amoxicillin clavulanic acid) + analgesic (diclofenac K).
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α-chemo-trypsin ampoules as anti-oedematous once daily for 5 days.
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Cold fomentation for 24 hours.
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Povidone Iodine mouth wash 4 times daily.
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Continue oral hygiene measures.
Follow-up phase
Clinical evaluation
Postoperative occlusion
The maximal intercuspal position (centric occlusion) was examined to ensure proper occlusal relationship including molar relation, canine relation, and midline centralization. Any disruption of the occlusal plane, such as an open bite or incorrect tooth contact, was observed. The maximum mouth opening was also assessed.
Radiographic evaluation (24)
An immediate postoperative CT scan was performed after surgery using the same parameters as the preoperative scan. The DICOM-formatted CT images were imported into the MIMICS software. The mandible was segmented in a similar manner to the preoperative planning procedure.
To evaluate the accuracy of the reduction, the distance was measured between the tip of the coronoid and the most anterior part of the chin (pogonion) (Fig. 3A) and the distance between the mental foramina was also measured (Fig. 3B). The preoperative and postoperative measurements were obtained and statistically compared.
The patients were followed up and another CT scan was taken after 3 months to evaluate bone healing and to estimate the mean bone density at the fracture line. Bone mineral density was calculated in Hounsfield Unit (HU) using the RadiAnt DICOM Viewer. Three measurements were taken along the fracture line, then the mean was calculated per patient (Fig. 3C).
Statistical Analysis
Statistical analysis was carried out using SPSS statistics software version 29 (SPSS, Inc., Chicago, IL). Quantitative data were tested for normality using Kolmogorov-Smirnov and Shapiro test. They were not normally distributed, it was described in terms of median, interquartile range, minimum and maximum. A non-parametric statistical test of significance was applied; Mann Whitney test was used to compare the parameters between virtual planning group and postoperative group. Wilicoxon signed rank test was used to compare the bone density immediate postoperative and 3 months after. In all applied statistical tests of significance, P value (< 0.05) was considered significant.