Orthognathic SurgeryNCT06714747
Soft Tissue Prediction in Orthognathic Surgery by Making Anatomically Accurate Virtual Model
An observational study of Orthognathic Surgery, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The role of orthognathic surgery in the correction of dento-skeletal dysmorphies, whether they are Class II or Class III or asymmetries, is to improve both the function and aesthetic appearance of thepatient. Both aspects are equally important to achieve optimal results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthognathic Surgery
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 11 Jan 2022to 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 years and older
- All sexes
- Adult, Older adult
Study population: Verranno arruolati 10 pazienti retrospettivamente. Per ogni paziente verranno effettuate 27 simulazioni virtuali variando le proprietà biomeccaniche delle singole parti. I dati verranno perciò analizzati su 270 interventi virtuali. Le 27 simulazioni procapite vengono determinate in base al range di variazione che in fase iniziale si decide di dare ai vari parametri biomeccanici presi in considerazione per ogni componente del modello (tessuti molli, muscoli, osso)14 . Un campione di 270 simulazione, consente di avere un intervallo di confidenza di 7.85 e un livello di confidenza del 99%. La tabella di seguito dimostra i valori massimi e minimi dati ai singoli muscoli per quanto riguarda il modulo di Young o modulo di elasticità.
Who may be able to join
- Patients undergoing orthognathic surgery and preoperative radiographic study with CBCT and MRI
- Patients with age > or = 18 years old
- Obtaining informed consent
- Patients with preoperative teleradiography and orthopantomography
Who cannot join
- patients with cleft lip-palate, facial malformations and/or syndromes (syndromes with involvement of the cephalic extremity, such as sd of Apert. Cropuzon, Ofeiffer, Treacher Collins)
- patients who have undergone application of Medpor prostheses or who have undergone ancillary procedures (lipofilling, fillers, volumetric facial augmentations with insertion of polyethylene ketone prostheses)
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
Achille Tarsitano, MD, 051 214 3415 ext. +39, achille.tarsitano2@unibo.it
About this study
The role of orthognathic surgery in the correction of dento-skeletal dysmorphies, whether they are Class II or Class III or asymmetries, is to improve both the function and aesthetic appearance of thepatient. Both aspects are equally important to achieve optimal results.
When the surgeon plans the surgery, he or she must therefore take into account the effects that bone displacements will have at the level of the soft tissues directly involved in the surgery, such as the maxilla and mandible. Traditionally, such surgery consists of an orthodontic presurgical phase1,2
.
Read the detailed description
The role of orthognathic surgery in the correction of dento-skeletal dysmorphies, whether they are Class II or Class III or asymmetries, is to improve both the function and cosmetic appearance of the patient. Both aspects are equally important to achieve optimal results.
When the surgeon plans the surgery, he or she must therefore take into account the effects that bone displacements will have at the level of the soft tissues directly involved in the surgery, such as the maxilla and mandible. Traditionally, such surgery consists of an orthodontic presurgical phase1,2
.
The current knowledge of facial aesthetics and its changes consequent to orthognathic surgery is given by studies mainly carried out in 2-dimensions, performed using radiographs (teleradiographs of the skull in PA and LL) and standard photographic material, on which two-dimensional cephalometric and anthropometric studies have been performed. A first fragility, related to less realism, lies in the fact that these represent objects in 2-dimensions when the human body is a structure in 3-dimensions, as well as the chiurgy that is going to be performed and the resulting changes are in the 3-dimensions of space. A second lesser precision of this method of records acquisition is the substantial impossibility of obtaining comparable material in the preoperative and postoperative periods, due to the understandable difficulty of homogeneous acquisition of the records themselves: photographs and radiographs . Recent advances in technology have generated a wide variety of 3-D methods that allow acquisition in the 3-dimensions of space of both surface structures and skeletal bases. These methods include: digital stereophotogrammetry, CT, MRI, and ECO-3D.
This new knowledge has then enabled 3D studies that were previously done in 2D: cephalometry, morphological analysis of the face
. To date, commercially available simulation software manages to be fairly accurate with regard to hard tissues (bone, teeth), but not reliable enough with regard to simulation of soft tissues overlying skeletal bases and consensual motion in the face of facial hard tissue surgery, as they do not take into account the biomechanical variety of individual soft tissue components
- Conditions
- Orthognathic Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcomes
Implementation of a virtual three-dimensional model of the face already provided for care procedure that is anatomically accurate in predicting soft tissue displacements following orthognathic surgery. This model will include the biomechanical characteristics of the facial muscles and skin.
In particular, the sensitivities of different areas of the face (nose, cheeks, and upper lip) that are particularly important in orthognathic surgery will be evaluated in response to variation in the biomechanical properties of the muscles (Poisson's coefficient and Young's modulus).
Measured: 18 months
Secondary outcomes (1)
secondary outcomes
Demonstrate whether the inclusion of anatomical details such as facial muscles improves virtual prediction by comparing the simulation model with what is obtained in reality. This comparison will be made by superimposing the 3D object obtained from the virtual soft tissue simulation with the 3D soft tissue object obtained from postoperative CBCT. Through a colorimetric scale ranging from - to + 5 mm, we will evaluate the distance between the 3D reconstruction actually obtained from the patient's postoperative CBCT and the virtual simulation of the anatomically complex model.
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 Dec 2024
- Study start11 Jan 2022
- 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 Orthognathic SurgeryStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- 10 participants (estimated)
Sponsor and investigators
- 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
- NCT06714747
- Sponsor's protocol ID
- CH MAX FAC 21 01
- Status last verified
- Oct 2024
- First submitted
- 28 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Prediction in Orthognathic Surgery by Making Anatomically Accurate Virtual Model
- ClinicalTrials.gov ID
- NCT06714747
- Acronym / sponsor ID
- CH MAX FAC 21 01
- Conditions
- Orthognathic Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 11 Sep 2026 (estimated)
- Study completion
- 11 Nov 2026 (estimated)
- First posted
- 4 Dec 2024 (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.
The role of orthognathic surgery in the correction of dento-skeletal dysmorphies, whether they are Class II or Class III or asymmetries, is to improve both the function and aesthetic appearance of thepatient. Both aspects are equally important to achieve optimal results.
When the surgeon plans the surgery, he or she must therefore take into account the effects that bone displacements will have at the level of the soft tissues directly involved in the surgery, such as the maxilla and mandible. Traditionally, such surgery consists of an orthodontic presurgical phase1,2
.
Detailed description
The role of orthognathic surgery in the correction of dento-skeletal dysmorphies, whether they are Class II or Class III or asymmetries, is to improve both the function and cosmetic appearance of the patient. Both aspects are equally important to achieve optimal results.
When the surgeon plans the surgery, he or she must therefore take into account the effects that bone displacements will have at the level of the soft tissues directly involved in the surgery, such as the maxilla and mandible. Traditionally, such surgery consists of an orthodontic presurgical phase1,2
.
The current knowledge of facial aesthetics and its changes consequent to orthognathic surgery is given by studies mainly carried out in 2-dimensions, performed using radiographs (teleradiographs of the skull in PA and LL) and standard photographic material, on which two-dimensional cephalometric and anthropometric studies have been performed. A first fragility, related to less realism, lies in the fact that these represent objects in 2-dimensions when the human body is a structure in 3-dimensions, as well as the chiurgy that is going to be performed and the resulting changes are in the 3-dimensions of space. A second lesser precision of this method of records acquisition is the substantial impossibility of obtaining comparable material in the preoperative and postoperative periods, due to the understandable difficulty of homogeneous acquisition of the records themselves: photographs and radiographs . Recent advances in technology have generated a wide variety of 3-D methods that allow acquisition in the 3-dimensions of space of both surface structures and skeletal bases. These methods include: digital stereophotogrammetry, CT, MRI, and ECO-3D.
This new knowledge has then enabled 3D studies that were previously done in 2D: cephalometry, morphological analysis of the face
. To date, commercially available simulation software manages to be fairly accurate with regard to hard tissues (bone, teeth), but not reliable enough with regard to simulation of soft tissues overlying skeletal bases and consensual motion in the face of facial hard tissue surgery, as they do not take into account the biomechanical variety of individual soft tissue components
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Verranno arruolati 10 pazienti retrospettivamente. Per ogni paziente verranno effettuate 27 simulazioni virtuali variando le proprietà biomeccaniche delle singole parti. I dati verranno perciò analizzati su 270 interventi virtuali. Le 27 simulazioni procapite vengono determinate in base al range di variazione che in fase iniziale si decide di dare ai vari parametri biomeccanici presi in considerazione per ogni componente del modello (tessuti molli, muscoli, osso)14 . Un campione di 270 simulazione, consente di avere un intervallo di confidenza di 7.85 e un livello di confidenza del 99%. La tabella di seguito dimostra i valori massimi e minimi dati ai singoli muscoli per quanto riguarda il modulo di Young o modulo di elasticità.
Key inclusion criteria (4 listed)
- Patients undergoing orthognathic surgery and preoperative radiographic study with CBCT and MRI
- Patients with age > or = 18 years old
- Obtaining informed consent
- Patients with preoperative teleradiography and orthopantomography
Key exclusion criteria (2 listed)
- patients with cleft lip-palate, facial malformations and/or syndromes (syndromes with involvement of the cephalic extremity, such as sd of Apert. Cropuzon, Ofeiffer, Treacher Collins)
- patients who have undergone application of Medpor prostheses or who have undergone ancillary procedures (lipofilling, fillers, volumetric facial augmentations with insertion of polyethylene ketone prostheses)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
primary outcomes
Time frame: 18 months
Implementation of a virtual three-dimensional model of the face already provided for care procedure that is anatomically accurate in predicting soft tissue displacements following orthognathic surgery. This model will include the biomechanical characteristics of the facial muscles and skin. In particular, the sensitivities of different areas of the face (nose, cheeks, and upper lip) that are particularly important in orthognathic surgery will be evaluated in response to variation in the biomechanical properties of the muscles (Poisson's coefficient and Young's modulus).
1 secondary outcome
secondary outcomes
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 Dec 2024.
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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 Orthognathic Surgery, 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 4 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 Dec 2024. 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 (051 214 3415 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 outcomes (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 Dec 2024.