Actively Recruiting

Age: 18Years - 60Years
All Genders
ID06806605

Full-3D Computer-Assisted Workflow for the Diagnosis and Correction of Dentofacial Deformities

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-02-04

50

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Dentofacial deformities involve significant differences from normal facial proportions and tooth alignment, causing difficulties in chewing, swallowing, speaking, and affecting facial appearance. These issues can lead to psychological distress due to facial disharmony and impaired social interactions. The conditions studied mainly involve skeletal differences between the upper and lower jaws that cannot be corrected with orthodontics alone, requiring combined orthodontic and surgical approaches for effective treatment. The study evaluates a full 3D computer-assisted workflow for diagnosing and correcting dentofacial deformities, focusing on orthognathic surgery. This surgery repositions the jaws in three dimensions to correct malocclusions such as Class 2, Class 3, and facial asymmetries that are not treatable by orthodontics alone. The process uses advanced imaging techniques like CT scans and 3D cephalometry, along with computer-assisted surgical planning and CAD-CAM devices to simulate and guide surgery. The treatment follows phases including pre-surgical orthodontics, surgery, and post-surgical orthodontic stabilization. Participants undergo three main study periods: initial 3D documentation before treatment (T0), preoperative documentation one month before surgery (T1), and final documentation within 12 months after completing treatment (T2). Researchers collect detailed imaging and clinical data at each stage to analyze treatment outcomes over 18 months. The study monitors jaw position, facial structure, and occlusion changes, aiming to improve planning and communication between surgeons, orthodontists, and patients throughout the treatment journey.

CONDITIONS

Brief Title

Full-3D Computer-Assisted Workflow for the Diagnosis and Correction of Deformities? Dentofacial

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with dentoskeletal dysmorphia.
  • Patients undergoing orthognathic surgery.
  • Patients between 18 and 60 years of age at the time of orthognathic surgery.
  • Obtaining informed consent.
Not Eligible

You will not qualify if you...

  • Patients who have undergone other facial surgeries during the treatment period.
  • Patients who have not followed the data collection phases foreseen in the 3D Study.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Variable, before treatment starts

Participants undergo initial 3D studies to collect documentation before starting orthodontic-surgical treatment.

1 visit (in-person)

Preoperative Assessment

Duration - Around 1 month before surgery

Participants complete a preoperative 3D study approximately one month before surgery to collect preoperative documentation.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery and immediate recovery period

Participants undergo orthognathic surgery as part of their treatment.

1 visit (in-person) for surgery

Post-operative Follow-up

Duration - Up to 12 months after surgery

Participants perform the final 3D study to collect documentation within 12 months after surgery, completing the orthodontic-surgical treatment.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

IRCCS - Azienda Ospedaliero Universitaria di Bologna

Bologna, Emilia-Romagna, Italy, 40138

Actively Recruiting

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Research Team

C

Claudio Marchetti, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Frequently Asked Questions

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