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Active, Not Recruiting

NCT Number: NCT07574554

Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation

Hypothesis The investigators hypothesis that fixation of mandibular angle fractures using a 3D titanium miniplate will provide better occlusal bite force than intraoral fixation using the standard two-plate technique.

The investigators expect that this method will facilitate a faster recovery time for participants to regain baseline occlusion force.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Mandible Fracture Craniocerebral Trauma Facial Injuries Force Measurement Fractures, Bone Jaw Fractures Mandibular Fractures Maxillofacial Injuries Nervous System Diseases Skull Fractures Trauma, Nervous System Wounds and Injuries

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of oral and dental medicine ,cairo university , oral and maxillodical department

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • Age from 20 to 50years.
  • Male .
  • Patients with mandibular angle fractures.

Exclusion criteria

  • • Patients with contraindication to general anesthesia
  • Patients with comminuted angle fractures.
  • Patients with relevant systemic diseases contraindicating surgery or affecting bone healing.
  • Patients with infected condyle and coronoid fractures.
  • Gun-shot injuries.
  • Edentulous fractures.
  • Pathological fractures.

Treatment and study plan

Two Standard Plate Fixation

Device

Fixation using two titanium miniplates. One plate at the inferior border of the mandible with bicortical screws. Second plate ~5 mm above or at the external oblique ridge with monocortical screws.

Other names: two Titanium Miniplates Fixation ,Dual Miniplate Fixation ,Conventional Two-Plate Technique.

3D Titanium Miniplate (2.0 mm, 8-hole).

Device

Single 2.0 mm 9-hole 3D titanium plate fixed with monocortical screws. Plate contoured with horizontal crossbars perpendicular and vertical struts parallel to fracture line. Screws placed diagonally first.

Other names: Single 3D Titanium Plate, 2.0 mm Thickness, 6-Hole Rectangular 6-Hole ,3D Titanium Miniplate 3D Contoured Titanium Plate, 2.0 mm, 6-Hole

Primary outcomes

  1. Occlusal force

    Time frame: first day surgery , second visit 30 days , the last visit 120 days. .

    use bite force measurement device . make patient bite to muser the force (, newton unit).

Secondary outcomes

  1. maximal incisal opening.

    Time frame: first day surgery , second visit 30 days , the last visit 120 days. .

    Ask the patient to open their mouth as wide as possible without feeling pain.

    Using a ruler or caliper, measure the vertical distance between the incisal edge of the upper central incisor and the incisal edge of the lower central incisor

  2. Patient satisfaction

    Time frame: first day surgery , second visit 30 days , the last visit 120 days. .

    will be measured on a visual analogue scale (VAS) with zero being unsatisfied and ten being satisfied and happy .

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation a Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 8, 2026
Registry last updated
May 8, 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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