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OpenTrials
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NCT Number: NCT06392204

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Procedure

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

Procedure

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

Primary outcomes

  1. Guide accuracy in repositioning of the fractured segments and in comparison to the preoperative 3D virtual surgical plan.

    Time frame: Outcome will be assessed with preoperative CT (T1-Week 1)immediate postoperative CT at (T3-Week 3)

    Accuracy of postoperative reduction by superimposition of 3D CT data on a 3D specialized software

Secondary outcomes

  1. Postoperative occlusion

    Time frame: Outcome will be assessed clinically at T2 (Week 2) and T3 (Week 3)

    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)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2024
Registry last updated
Apr 9, 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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