Evaluation of Modified Omega Plate in the Management of Mandibular Fractures Compared With Conventional Fixation

NCT ID: NCT07206134

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-08-04

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.

Conditions

Mandibular Fractures; Fracture in Mental Nerve Region

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Modified Omega bone plate used 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

Group Type: EXPERIMENTAL

Modified Omega bone plate for fixation of mandibular fractures in mental foramen region

Intervention Type: PROCEDURE

Reflection of vestibular flap without dissection around mental bundle and fracture reduction and fixation with 3D Modified Omega bone plate

Conventional miniplates used for fixation of mandibular fractures in mental foramen region

Reflection of vestibular flap and dissection around mental bundle and fracture reduction and fixation with 2 miniplates

Group Type: EXPERIMENTAL

Conventional miniplates for fixation of mandibular fractures

Intervention Type: PROCEDURE

Reflection of vestibular flap with dissection around mental bundle and fracture reduction and fixation with 2 miniplates

Interventions

Modified 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

Intervention Type: PROCEDURE

Conventional miniplates for fixation of mandibular fractures

Reflection of vestibular flap with dissection around mental bundle and fracture reduction and fixation with 2 miniplates

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed sobhie abdelhameed

Principal Investigator, Teaching Assistant of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Egypt faculty of dentistry, tanta university

Tanta, , Egypt

Countries

Egypt

Other Identifiers

TantaOMS-OMEGAvsCONV-2025

Identifier Type: -

Identifier Source: org_study_id