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NCT Number: NCT07390734

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Mandibular Angle Fracture

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of dentistry, Alexandria university

Alexandria, 21523, Egypt

About this study

Eighteen patients with mandibular angle fractures will be selected. In nine fractures, custom-made three dimensional titanium plates will be used for fracture fixation (study group); while in the other nine, conventional two mini plates will be used (control group),via intra oral approach (combined with transbuccal approach) for both groups. Patients will be evaluated clinically, and radiographically (immediate and four months post operative) to evaluate the bone density at the fracture line.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

custom-made 3D titanium plates

Device

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

standared two mini plates

Device

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

Primary outcomes

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

    Time frame: 4 months

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

Secondary outcomes

  1. Post operative pain

    Time frame: 3 months

    • Post operative pain This will be subjectively evaluated with a visual analogue scale (VAS) with values from 0 (no pain) to 10 (strongest pain).

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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