Patient Specific 3d Titanium Plate Versus Standard Two Mini Plates in the Fixation of Mandibular Angle Fractures (a Randomized Controlled Clinical Trial)

NCT07390734 | Active Not Recruiting Phase 4

• 1 other identifier: 1023-01/2025
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effectiveness of custom-made (3D) titanium plates to standard two titanium mini plates in fixation of mandibular angle fracture.

Conditions

Mandibular Angle Fracture

Keywords

three dimensional plates; mandibular angle fracture; patient specific plate

Outcome Measures

Primary Outcomes (1)

• Radiographic evaluation for the assessment of mean bone density at the fracture line

  Mean bone density at the fracture line was assessed using Computed Tomography (CT) scan in Hounsfield Units (HU)

  4 months

Secondary Outcomes (1)

• Post operative pain

  3 months

Study Arms (2)

patients with recent mandibular angle fractures managed with custom-made 3D titanium plates

EXPERIMENTAL

patients that will undergo internal fixation with custom-made 3D titanium plates through intaoral and transbuccal approach .

Device: custom-made 3D titanium plates

patients with recent mandibular angle fractures managed with standared two mini plates

EXPERIMENTAL

patient that will undergo internal fixation with standared two mini plates through intaoral and transbuccal approach.

Device: standared two mini plates

Interventions

custom-made 3D titanium plates DEVICE

custom-made 3D titanium plates through intaoral and transbuccal approach .

patients with recent mandibular angle fractures managed with custom-made 3D titanium plates

standared two mini plates DEVICE

internal fixation with standared two mini plates through intaoral and transbuccal approach.

patients with recent mandibular angle fractures managed with standared two mini plates

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients suffering from mandibular angle fracture indicated for open reduction and fixation.
• Non infected mandibular angle fractures present less than two weeks. 3. Good oral hygiene.

You may not qualify if:

• Medically compromised patients contradicting operation (ASA III, IV \& V).
• Patients receiving radiotherapy or chemotherapy. 3- Bone diseases (Osteoporosis, Osteopetrosis, Osteomalacia…etc.) 4- Pathological fracture. 5- Old untreated fracture.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of dentistry, Alexandria university

Alexandria, 21523, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants complying with the inclusion criteria will be randomly assigned using a computer-generated list of random numbers to one of the two arms. Allocation will be performed by a trial independent individual and the allocation ratio is intended to be equal. Allocation will be in equal blocks to ensure that the study groups have equal number of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: January 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: April 30, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)