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Evaluation of Patient-specific Surgical Stents and Plates for Guided Reduction And Fixation of Mandibular Angle Fractures

A

Alexandria University

Status and phase

Completed
Phase 4

Conditions

Mandibular Angle Fracture

Treatments

Device: Patient specific surgical stents and plates for guided reduction and fixation of mandibular angle fixation

Study type

Interventional

Funder types

Other

Identifiers

NCT07375030
00010824-12/2023

Details and patient eligibility

About

This study will evaluate the patient specific surgical stent and plate for guided reduction and fixation of mandibular angle fractures.

Full description

seven patients with recent mandibular angle fractures indicated for open reduction and internal fixation were treated by patient specific surgical stent and plate for guided reduction and fixation of mandibular angle fractures. Follow-up extended to 12 weeks. Clinical parameters included pain, operative time, postoperative occlusion, wound healing and mouth opening. Radiographic evaluation was conducted using computed tomography scans acquired preoperatively and postoperatively ,superimposition of the pre and postoperative models will be done to create error map and measure the accuracy

Enrollment

7 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Medically fit patients free from relevant conditions contraindicating surgery.
  • Patients with mandibular angle fracture indicated for open reduction and internal fixation.
  • Presented within 2 weeks from trauma.

Exclusion criteria

  • Infected fracture site.
  • Patients with systemic bone diseases.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

7 participants in 1 patient group

patients with recent mandibular angle fractures managed with patient specific stents and plates
Experimental group
Treatment:
Device: Patient specific surgical stents and plates for guided reduction and fixation of mandibular angle fixation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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