Fracture in Mental Nerve Region, Mandibular Fractures
Conditions
Brief summary
Twelve adult patients with mandibular fractures in the mental region were enrolled and randomly divided into two equal groups. Group I received fixation using custom-designed modified omega bone plates, while Group II was treated with conventional titanium miniplates following Champy's technique. Virtual surgical planning and 3D printing technology were used to fabricate customized plates in Group I. Clinical and radiographic assessments were conducted immediately, at 1 week, 3 months, and 6 months postoperatively. Parameters evaluated included soft tissue healing, pain, facial edema, lower lip paresthesia, maximal mouth opening, occlusion, fracture stability, and hardware integrity.
Detailed description
This study was conducted on twelve adult patients with mandibular fracture in mental nerve region, selected from the outpatient clinic, Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University. The selected patients were randomly divided into two equal groups, group I (6 patients) were treated by modified omega bone plate, while group II (6 patients) were treated by 2.0 mm conventional miniplates according to Champy's principle. A comparison between the two groups was conducted. Modified Omega bone plate is a specially-designed, 8-hole, titanium miniplate modified by adding upper struts to the Ω symbol. It has lower horizontal struts (which provides stability along the lower border) with four holes, the proximal 2 holes are round and the distal are pear shape (compression holes). Two vertical struts at the ends of the horizontal struts (which provide resistance against the torsional forces),Upper horizontal struts (which counteract the tensional forces along the alveolar border) with four holes the proximal 2 holes are round and the distal are pear shape. The omega shape of this plate helps it to adapt easily around the mental neurovascular bundle. Preoperative evaluation of the patients was carried out by taking history and performing clinical and radiographic examinations. Clinical examination included intraoral and extraoral inspection and palpation of the fracture sites. Radiographic examination was used to determine the site, number, type of fractures and degree of displacement. Under general anesthesia, the fracture line was exposed through an intraoral approach, and the fracture segments were reduced. In group I, fixation of the reduced segments was done with modified omega bone plate which predetermined virtually. In group II, 2conventional miniplates placed on inferior border & subapical were used to fix the fracture. Postoperative clinical evaluation were performed immediately, one week, two weeks, one month, three months and postoperative radiographic evaluation were performed immediately, three months and six months. The postoperative clinical evaluation included presence or absence of infection, bony union or stability, state of occlusion, maximal mouth opening, sensory nerve function, condition of teeth related to the fracture line and, patient's tolerance to the plate.
Interventions
PROCEDUREModified Omega bone plate for fixation of mandibular fractures in mental foramen region
Reflection of vestibular flap without dissection around mental bundle and fracture reduction and fixation with 3D Modified Omega bone plate
PROCEDUREConventional miniplates for fixation of mandibular fractures
Reflection of vestibular flap with dissection around mental bundle and fracture reduction and fixation with 2 miniplates
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
using closed envelop for participants the data will be given to outcomes assessors without defining the intervention for each group
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients with displaced mandibular parasymphysis or body fracture in the mental nerve region Indicated for open reduction and internal fixation (ORIF)
Exclusion criteria
* Patients with systemic diseases that affect bone healing * Fractures with crushed mental foramen * Comminuted fractures where fixation is difficult * Patients with anatomical variations (e.g., bifid inferior alveolar or mental nerve), based on preoperative CT nerve tracing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity measured using Visual Analogue Scale (VAS) | At 1 day, 3 days, 1 week, and 1 month postoperatively | Pain will be assessed using a 10-cm Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurosensory function assessed by two point discrimination test | Up to 3 months | Sensory function tested using caliber |
| Maximal Interincisal Opening (MIO) | Preoperative, and postoperative day 1, day 3, 1 week, and 1 month | Measured using digital caliper between maxillary and mandibular central incisors. |
| Facial edema measured using linear facial measurements | At 1 day, 3 days, 1 week | Edema will be assessed utilizing a horizontal and vertical guide with a tape on four reference points: outer canthus of the eye, angle of the mandible, tragus of the ear and outer corner of the mouth respectively. To obtain the percentage of facial swelling, the difference between measurements of the postoperative and preoperative periods will be divided by the value of the preoperative period. Souza JA, Consone DP. Method for measurement of facial edema after oral surgery. |
| Operation Time | Intraoperative | Total duration of surgery measured from first incision to last suture. |
| Interfragmentary Gap | 1 day Postoperative | Linear measurement radiographically on immediate postoperative CT |
| Occlusion Status | Postoperative 1 week and 1 month | Clinical evaluation of occlusion compared with pre-injury status using ulgics questionnaire |
Countries
Egypt
Outcome results
None listed