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

NCT07206134 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-10-03

No results posted yet for this study

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

Interventions

PROCEDURE

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

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

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-12-01
Completion
2025-08-04

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07206134 on ClinicalTrials.gov