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

NCT07206134 | Completed DMC

• 1 other identifier: TantaOMS-OMEGAvsCONV-2025
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Mandibular Fractures; Fracture in Mental Nerve Region

Outcome Measures

Primary Outcomes (1)

• Pain intensity measured using Visual Analogue Scale (VAS)

  Pain will be assessed using a 10-cm Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).

  At 1 day, 3 days, 1 week, and 1 month postoperatively

Secondary Outcomes (6)

• Facial edema measured using linear facial measurements

  At 1 day, 3 days, 1 week

• Neurosensory function assessed by two point discrimination test

  Up to 3 months

• Maximal Interincisal Opening (MIO)

  Preoperative, and postoperative day 1, day 3, 1 week, and 1 month

• Occlusion Status

  Postoperative 1 week and 1 month

• Operation Time

  Intraoperative

Study Arms (2)

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

Procedure: Conventional miniplates for fixation of mandibular fractures

Interventions

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

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

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

Conventional miniplates for fixation of mandibular fractures PROCEDURE

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

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with displaced mandibular parasymphysis or body fracture in the mental nerve region
• Indicated for open reduction and internal fixation (ORIF)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Egypt faculty of dentistry, tanta university

Tanta, Egypt

Location

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: using closed envelop for participants the data will be given to outcomes assessors without defining the intervention for each group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Teaching Assistant of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University

Model Details: Parallel assignment

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: October 3, 2025
• Study Start: March 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: August 4, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

EG (1)