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

NCT06838377 | Not Yet Recruiting

• 1 other identifier: 0032025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Mandible Fracture

Outcome Measures

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.

  3 months

Study Arms (2)

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

EXPERIMENTAL

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. In Group I, 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.

Device: computer guided screw holes locating guide and Patient Specific Champy plate

conventional Champy plate osteosynthesis in management of mandibular angle fracture

ACTIVE COMPARATOR

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.

Device: standard Champy mini plate

Interventions

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.

conventional Champy plate osteosynthesis in management of mandibular angle fracture

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.

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

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Poor oral hygiene and motivation.
• Uncontrolled diabetes.
• Pregnant or nursing.
• Substance abuse.
• Psychiatric problems or unrealistic expectations.
• Severe bruxism or clenching.
• Immunosuppressed or immunocompromised.
• Treated or under treatment with intravenous amino-bisphosphonates.
• Patients participating in other studies, if the present protocol could not be properly followed.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Cairo university

Cairo, 11511, Egypt

Location

Cairo university

Cairo, 3753450, 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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: general practioner dentist

Model Details: Digital planning and custom made Champy plate manufacturing: Dental arches will be segmented and waxed to the ideal occlusal relationship either by mounting on semi adjustable articular or digitally. Superimposed on the CT scan using specialized software, (3Matic software Mimics-Materialize, Belgium) which also segment and realign the fracture segments virtually. Biomedical engineers will design the custom made Champy plate adapted on the ventral surface of the exterior oblique ridge (Champy's line of osteosynthesis) ensuring there is adequate clearance of the screw hole positions and screw lengths on the plate to avoid critical nerves, blood vessels, and adjacent teeth. Biomedical engineers will also design a screw hole locating device 3D printed of resin. The custom made Champy plate will be 3D printed in titanium using laser sintering of titanium powder (Cerea and Dolcini, 2018) with heat treatment post-processing.

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 20, 2025
• Study Start: February 25, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

EG (2)