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Recruiting Observational

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

NCT06806605 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2020-01-11
Last updated
2025-02-04

Condition(s) studied

Dentofacial Deformities

Investigational drug(s) / intervention(s)

3d analisys

3d analisys: To analyze the orthodontic-surgical set-up carried out as part of the normal care pathway of patients operated since January 2015 and who completed treatment on May 30, 2020 in the Orthodontic First patient.

Study summary

"Dentofacial deformity refers to deviations from the norm of facial proportions and tooth ratios of such magnitude as to represent a disability." \[1\] These conditions afflicted two aspects of the patient's health: the first related to the functions performed by the stomatognathic apparatus (mastication, swallowing, phonation, etc...), the second related to the morphology of the face, which--by virtue of the severe disharmony of its parts--did not fully realize its function as an organ of relationships, leading the patient to high levels of psychological distress.

The nature of the dentofacial deformities was mainly related to skeletal discrepancies between the maxillae, such that the malocclusion could not be resolved by orthodontic treatment alone. The resolution of these conditions required a perfect synergy between orthodontic therapy (aimed at dental alignment of the individual arches) and surgical therapy (aimed at morphological harmonization of the face and obtaining the correct occlusion).

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: * 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.Inclusion criteria * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • primary outcome — 18 months
    The primary outcome are : analyze the surgical orthodontic set-up at time T0 (pre-treatment phase) in relation to the decompensation orthodontics actually performed and the surgery actually planned at time T1 (pre-operative phase).

Trial sites (1)

FacilityCityRegionStatus
IRCCS - Azienda Ospedaliero Universitaria di Bologna Bologna Emilia-Romagna Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06806605 on ClinicalTrials.gov ↗ ← All trials in Italy