Evaluation of Modified Omega Plate in the Management of Mandibular Fractures Compared With Conventional Fixation
- Conditions
- Mandibular FracturesFracture in Mental Nerve Region
- Registration Number
- NCT07206134
- Lead Sponsor
- Tanta University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Patients with displaced mandibular parasymphysis or body fracture in the mental nerve region
Indicated for open reduction and internal fixation (ORIF)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Neurosensory function assessed by two point discrimination test Up to 3 months Sensory function tested using caliber
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.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.
Occlusion Status Postoperative 1 week and 1 month Clinical evaluation of occlusion compared with pre-injury status using ulgics questionnaire
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
Trial Locations
- Locations (1)
Egypt faculty of dentistry, tanta university
🇪🇬Tanta, Egypt
Egypt faculty of dentistry, tanta university🇪🇬Tanta, Egypt