NCT06806605

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Jan 2020Nov 2026

Study Start

First participant enrolled

January 11, 2020

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2026

Last Updated

February 4, 2025

Status Verified

October 1, 2024

Enrollment Period

6.7 years

First QC Date

November 28, 2024

Last Update Submit

January 28, 2025

Conditions

Dentofacial Deformities

Outcome Measures

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).

    18 months

Secondary Outcomes (1)

  • secondary outcome

    18 months

Other Outcomes (1)

  • pre-specified outcomes

    18 months

Study Arms (3)

T0 Initial 3D study

T0: the patient has not yet started orthodontic-surgical treatment and is carrying out the initial documentation collection;

Other: 3d analisys

T1 Preoperative 3D study

T1: the patient one month before surgery who collects the preoperative documentation;

Other: 3d analisys

T2 Final 3D study

T2: the patient has completed the orthodontic-surgical treatment and performs the collection of the final documentation. It is carried out within 12 months of the intervention.

Other: 3d analisys

Interventions

3d analisysOTHER

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.

T0 Initial 3D studyT1 Preoperative 3D studyT2 Final 3D study

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study 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)

You may qualify if:

  • Patients with dentoskeletal dysmorphia.
  • Patients undergoing orthognathic surgery.
  • Patients between 18 and 60 years of age at the time of orthognathic surgery.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS - Azienda Ospedaliero Universitaria di Bologna

Bologna, Emilia-Romagna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Dentofacial Deformities

Condition Hierarchy (Ancestors)

Maxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesStomatognathic System AbnormalitiesStomatognathic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Claudio Marchetti, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudio Marchetti, MD

CONTACT

051 241 8362claudio.marchetti@aosp.bo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2024

First Posted

February 4, 2025

Study Start

January 11, 2020

Primary Completion (Estimated)

September 11, 2026

Study Completion (Estimated)

November 11, 2026

Last Updated

February 4, 2025

Record last verified: 2024-10

Locations

IT(1)