Accuracy of Computer Guided Screw Holes Locating Guide and Patient Specific Champy Plate vs Conventional Champy Plate Osteosynthesis in Management of Mandibular Angle Fracture: Randomized Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-60
SponsorCairo University

About this trial

the aim of our study is to assess computer guided mandibular fracture reduction and to prove its lower rate of complications and higher accuracy of reduction compared to the conventional approach in management of mandibular angle fracture.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with isolated mandibular angle fracture needs open reduction and internal fixation.

Patients with medical history that did not hinder plate placement and adequate proper oral hygiene.

Both genders males and females will be included.

Disqualifiers

General contraindications to surgery. .

Patients with comminuted fractures.

Subjected to irradiation in the head and neck area less than 1 year before fixation.

Untreated periodontitis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • standard Champy mini plate

    Device

    the operation will under general anesthesia with nasal intubation and oral pack, Injection of 20 cc saline adrenaline 1:00000 to 0 in the sulcus for hemostasis, Vestibular mucosal incision, Reflect the flap to visualize the broken segments. Full thickness mucoperiosteal flaps were then carefully raised to expose enough underlying alveolar bone then mobilize the broken segment , Arch bar was made to achieve proper occlusion put the Champy 2.0 plate on the ventral surface of the external oblique of the mandible and remove it for further bending using plate pliers for further accommodation of the plate then fix it in place using mono cortical screws.

  • computer guided screw holes locating guide and Patient Specific Champy plate

    Device

    the operation will under general anesthesia with nasal intubation and oral pack, Injection of 20 cc saline adrenaline 1:00000 to 0 in the sulcus for hemostasis, Vestibular mucosal incision, Reflect the flap to visualize the broken segments. Full thickness mucoperiosteal flaps were then carefully raised to expose enough underlying alveolar bone to accommodate the screw holes locating guide and the custom-made Champy plate. , Put the specific screw holes locating device in place and drill the screw holes, remove the screw holes locating device and mobilize the segments then apply the custom-made Champy plate and fix it with screw for passive reduction of the segments. Then suture the mucosa.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: computer guided screw holes locating guide and Patient Specific Champy plate osteosynthesisExperimental treatment 1 intervention
Group B: conventional Champy plate osteosynthesis in management of mandibular angle fractureActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Accuracy of computer guided screw holes locating guide and Patient Specific Champy plate in management of mandibular angle fracture

calculate any amount for segments deviation from the virtual plan in mms.

Time frame
3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: