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CAD/CAM Angle Fracture Reduction/Plate Guide and Customized 3D Grid Plate Versus Champy's Technique

NCT ID: NCT06392204

Last Updated: 2024-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-07

Study Completion Date

2024-12-31

Brief Summary

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This proposed study aims at creating a computer designed patient specific device and titanium plates, that are 3D manufactured in accordance to a preoperative computer aided virtual surgical procedure, aiming to obtain proper alignment of fractured segments of the lower jaw and restore proper teeth positioning therefore overcoming the possible complications of the conventional methods.

Recruited participants will be randomly allocated to a treatment groupp, whether the novel method group or a standard treatment group.

Preoperative panoramic radiograph and a Computed tomography scan will be obtained for each patient.

Surgical procedure will be conducted unde general anesthetic. Medications will be prescribed after surgery and instructions will be given to each patient.

Follow up will be on a weekly basis for the first 6 weeks followed by a followup visit once a month for 6 months.

Postoperative panoramic radiograph and a Computed tomography scan will be obtained at 1 week after the surgical procrdure and again 6 months later.

Digital data obtained from computed tomography scans along with clinical data will be analysed and studied to determine the accuracy of the computer aided device and for comparison with the standard method of treatment.

Detailed Description

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Conditions

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Mandibular Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Custom made reduction guides and 3D grid plates

Mandibular angle fracture reduction and fixation using digitally designed and fabricated patient specific fracture reduction/plate positioning guide and customized 3D grid plate

Group Type EXPERIMENTAL

CAD/CAM patient specfifc fracture reduction/plate guide and customized 3D grid plate

Intervention Type PROCEDURE

Mandibular angle fracture reduction and fixation using digitally designed and fabricated patient specific fracture reduction/plate positioning guide and customized 3D grid plate

Stock titanium plates

Mandibular angle fracture reduction and fixation using a single superior border 2.0 miniplate

Group Type ACTIVE_COMPARATOR

Champy's techqniue

Intervention Type PROCEDURE

Mandibular angle fracture reduction and fixation using a single superior border 2.0 miniplate

Interventions

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CAD/CAM patient specfifc fracture reduction/plate guide and customized 3D grid plate

Mandibular angle fracture reduction and fixation using digitally designed and fabricated patient specific fracture reduction/plate positioning guide and customized 3D grid plate

Intervention Type PROCEDURE

Champy's techqniue

Mandibular angle fracture reduction and fixation using a single superior border 2.0 miniplate

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients with unilateral mandibular angle fracture with or without associated mandibular fractures in need of open reduction and internal fixation.
2. Patients above 18 years old
3. Sufficient dentition to reproduce the occlusal relationships
4. Patient's consent to participate

Exclusion Criteria

1. Patients with comminuted mandibular angle fracture(s)
2. Patients with any systemic disease that may affect normal healing
3. Patients undergoing chemotherapy or radiotherapy related to the head and neck region
4. Intra-bony lesions in the fracture area that may interfere with proper anatomical reduction.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Arwa Louay Ali Hosni

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Arwa Hosni, MSc

Role: primary

Mohamed AbdElRasoul

Role: backup

Other Identifiers

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PSIs

Identifier Type: -

Identifier Source: org_study_id