Dentofacial DeformitiesNCT06806605
Full-3D Computer-Assisted Workflow for the Diagnosis and Correction of Deformities? Dentofacial
An observational study of Dentofacial Deformities, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dentofacial Deformities
- What is being tested?
- 3d analisys
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 11 Jan 2020to 11 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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)
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS - Azienda Ospedaliero Universitaria di Bologna
Bologna, Emilia-Romagna, 40138
Claudio Marchetti, MD, 051 214 3415 ext. +39, claudio.marchetti@aosp.bo.it
About this study
"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).
Read the detailed description
Orthognathic Surgery
Orthognathic surgery allows the repositioning of the jaws in all three spatial planes. This procedure is indicated for patients with:
- Class 3 malocclusion, caused by maxillary retrusion, mandibular prognathism, or a combination of the two;
- Class 2 malocclusion, due to mandibular retrusion, with a normally conformed, protruded, or retruded maxilla and/or with excessive verticality;
- Class 1 malocclusion, characterized by consensual bimaxillary retrusion (a condition that may be seen in complex medical issues, such as in OSAS patients);
- Facial asymmetries caused by overgrowth on one side or facial torsion;
- Other malocclusions not correctable with orthodontic treatment alone, such as transversal or dento-alveolar deficits;
- Sequelae from facial trauma.
Orthognathic surgery has progressed rapidly since the 1950s when surgical techniques for treating most malocclusions that could not be resolved through orthodontics alone were first developed.
Subsequent technological advances have simplified the diagnosis of dentofacial deformities in three dimensions: Multislice CT (MSCT), Cone Beam CT (CBCT), Magnetic Resonance Imaging (MRI), stereophotogrammetry, dental arch scanning, software that allows surgical planning and outcome prediction, intraoperative navigation, and CAD-CAM technology. The conventional approach to orthognathic surgery (Orthodontic-first) consists of three phases: pre-surgical orthodontic treatment, the surgical phase, and post-surgical occlusion stabilization (post-surgical orthodontic treatment).
Orthognathic Surgery and Technology: From 2D Study to 3D To diagnose dentofacial deformities, the investigators have utilized 3D digital records created through dedicated software or devices. Real data and digital information are combined to simulate the surgical procedure.
3D Cephalometry Cephalometry is the method used to analyze the geometry of facial structures. Historically, this method was based on 2D radiology. The use of CT allowed the application of the same geometric criteria to 3D reconstructions of the skull and face. Studies assessing its accuracy showed that this method is comparable to standard 2D cephalometry for known measurements, but it adds a significant amount of new information, particularly regarding the rotational and translational aspects of the jaws and individual teeth.
3D Surgical Planning It is now possible to plan surgery using computer-assisted digital methods. The surgical plan can be transferred accurately to the patient through CAD-CAM-manufactured devices. The planning process can simulate both orthodontic and/or surgical treatment.
At the University of Bologna, the investigators have extensive experience with intraoperative navigation guided by 3D virtual simulation, combining navigation and virtual 3D surgery. they also have expertise in producing individualized CAD-CAM synthesis devices. It has been previously demonstrated that virtual orthodontic planning is as reliable as traditional methods using plaster models in orthodontic-only patients.
In fact, incorporating digital orthodontic planning into the orthodontic/surgical workflow is of great importance for the following reasons:
- Initial treatment prediction to better guide therapeutic choices;
- Improved communication between orthodontists and surgeons;
- Enhanced communication with patients, providing an accurate prediction of the treatment plan from the beginning.
- Conditions
- Dentofacial Deformities
- Being tested
- 3d analisys
- Medical subject headings
- Dentofacial Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| T0 Initial 3D study | T0: the patient has not yet started orthodontic-surgical treatment and is carrying out the initial documentation collection; Receives: Other: 3d analisys | |
| T1 Preoperative 3D study | T1: the patient one month before surgery who collects the preoperative documentation; Receives: 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. Receives: Other: 3d analisys |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start11 Jan 2020
- Primary completion11 Sep 2026 (estimated)
- Study completion11 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentofacial DeformitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudio Marchetti, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806605
- Sponsor's protocol ID
- FULL-3D OS
- Status last verified
- Oct 2024
- First submitted
- 28 Nov 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full-3D Computer-Assisted Workflow for the Diagnosis and Correction of Deformities? Dentofacial
- ClinicalTrials.gov ID
- NCT06806605
- Acronym / sponsor ID
- FULL-3D OS
- Conditions
- Dentofacial Deformities
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 11 Jan 2020 (actual)
- Primary completion
- 11 Sep 2026 (estimated)
- Study completion
- 11 Nov 2026 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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).
Detailed description
Orthognathic Surgery
Orthognathic surgery allows the repositioning of the jaws in all three spatial planes. This procedure is indicated for patients with:
- Class 3 malocclusion, caused by maxillary retrusion, mandibular prognathism, or a combination of the two;
- Class 2 malocclusion, due to mandibular retrusion, with a normally conformed, protruded, or retruded maxilla and/or with excessive verticality;
- Class 1 malocclusion, characterized by consensual bimaxillary retrusion (a condition that may be seen in complex medical issues, such as in OSAS patients);
- Facial asymmetries caused by overgrowth on one side or facial torsion;
- Other malocclusions not correctable with orthodontic treatment alone, such as transversal or dento-alveolar deficits;
- Sequelae from facial trauma.
Orthognathic surgery has progressed rapidly since the 1950s when surgical techniques for treating most malocclusions that could not be resolved through orthodontics alone were first developed.
Subsequent technological advances have simplified the diagnosis of dentofacial deformities in three dimensions: Multislice CT (MSCT), Cone Beam CT (CBCT), Magnetic Resonance Imaging (MRI), stereophotogrammetry, dental arch scanning, software that allows surgical planning and outcome prediction, intraoperative navigation, and CAD-CAM technology. The conventional approach to orthognathic surgery (Orthodontic-first) consists of three phases: pre-surgical orthodontic treatment, the surgical phase, and post-surgical occlusion stabilization (post-surgical orthodontic treatment).
Orthognathic Surgery and Technology: From 2D Study to 3D To diagnose dentofacial deformities, the investigators have utilized 3D digital records created through dedicated software or devices. Real data and digital information are combined to simulate the surgical procedure.
3D Cephalometry Cephalometry is the method used to analyze the geometry of facial structures. Historically, this method was based on 2D radiology. The use of CT allowed the application of the same geometric criteria to 3D reconstructions of the skull and face. Studies assessing its accuracy showed that this method is comparable to standard 2D cephalometry for known measurements, but it adds a significant amount of new information, particularly regarding the rotational and translational aspects of the jaws and individual teeth.
3D Surgical Planning It is now possible to plan surgery using computer-assisted digital methods. The surgical plan can be transferred accurately to the patient through CAD-CAM-manufactured devices. The planning process can simulate both orthodontic and/or surgical treatment.
At the University of Bologna, the investigators have extensive experience with intraoperative navigation guided by 3D virtual simulation, combining navigation and virtual 3D surgery. they also have expertise in producing individualized CAD-CAM synthesis devices. It has been previously demonstrated that virtual orthodontic planning is as reliable as traditional methods using plaster models in orthodontic-only patients.
In fact, incorporating digital orthodontic planning into the orthodontic/surgical workflow is of great importance for the following reasons:
- Initial treatment prediction to better guide therapeutic choices;
- Improved communication between orthodontists and surgeons;
- Enhanced communication with patients, providing an accurate prediction of the treatment plan from the beginning.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T0 Initial 3D study | – | Other: 3d analisysT0: the patient has not yet started orthodontic-surgical treatment and is carrying out the initial documentation collection; |
| T1 Preoperative 3D study | – | Other: 3d analisysT1: the patient one month before surgery who collects the preoperative documentation; |
| T2 Final 3D study | – | Other: 3d analisysT2: 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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)
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3d analisysTo 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. | Other | T0 Initial 3D study, T1 Preoperative 3D study, T2 Final 3D study |
Primary outcome
primary outcome
Time frame: 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).
1 secondary outcome
secondary outcome
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudio Marchetti, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dentofacial Deformities, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudio Marchetti, MD (051 241 8362 ext. +39, claudio.marchetti@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary outcome (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.