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

Mandibular Fractures Clinical Trial

Official title:

Assessment of Mandibular CAD/CAM Angle Fracture Reduction/Plate Guide and Customized 3D Grid Plate Versus Champy's Technique (A Randomized Controlled Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06392204
• Other study ID #: PSIs
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Mandibular Fractures

Intervention

Procedure:
• 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
• Champy's techqniue
Mandibular angle fracture reduction and fixation using a single superior border 2.0 miniplate

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Guide accuracy in repositioning of the fractured segments and in comparison to the preoperative 3D virtual surgical plan.	Accuracy of postoperative reduction by superimposition of 3D CT data on a 3D specialized software	Outcome will be assessed with preoperative CT (T1-Week 1)immediate postoperative CT at (T3-Week 3)
Secondary	Postoperative occlusion	Assessment of postoperative occlusion clinically using a millimeter caliper, occlusion will be categorized into; satisfactory (no gap), mild derangement (gap of 1-2 mm) and deranged (gap more than 2 mm)	Outcome will be assessed clinically at T2 (Week 2) and T3 (Week 3)