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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

"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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

All patients operated since January 2015 and who completed the "T2" follow-up by May 30, 2020, at the Maxillofacial Surgery Department (AOU di Bologna), who followed the normal care pathway provided for cases of dentoskeletal dysmorphosis, which consisted of: T0: Initial 3D study (before the start of orthodontic treatment) T1: Preoperative 3D study (1 month after surgery) T2: Final 3D study (at the end of post-operative orthodontic treatment with the appliance removed)

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • 3d analisys

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: T0 Initial 3D study1 intervention
Group B: T1 Preoperative 3D study1 intervention
Group C: T2 Final 3D study1 intervention

Trial outcomes

Primary outcomes

1

primary outcome

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).

Time frame
18 months

Secondary outcomes

1

secondary outcome

evaluate the accuracy of the surgical orthodontic set-ups performed at time T0 and T1 in relation to the results obtained at the end of the treatment in the patient at time T2 (patient who has completed the surgical orthodontic treatment).

Time frame
18 months

Other outcomes

1

pre-specified outcomes

* "T0": the patient has not yet started orthodontic-surgical treatment and performs the initial documentation collection; * "T1": the patient one month before surgery who performs the collection of the pre-operative documentation; * Surgical intervention; * "T2": the patient has completed orthodontic-surgical treatment and who performs the collection of the final documentation. It is performed within 12 months of surgery.

Time frame
18 months

Sponsors and contacts

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