Dentofacial DeformitiesMandiFirstNCT06907745
Splintless Virtual Surgical Plan with Mandible-first Technique: 3D Accuracy Analysis
An observational study of Dentofacial Deformities, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
Accuracy assessment through three-dimensional superposition of the post-operative volumetric CT and the digital therapeutic project files. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dentofacial Deformities
- What is being tested?
- Bimaxillary Osteotomy
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 24 Apr 2024to 31 Dec 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with diagnosis of dentoskeletal disorders
Who may be able to join
- Men and women
- Age over 18 and under 60
- Diagnosis of dento-skeletal dysmorphosis involving the middle third and lower part of the face
- Patients with consent to surgery
- Patients in good general health according to the evaluation of the PI and on the basis of the anamnesis and clinical examination
Who cannot join
- History of previous maxillomandibular fracture
- Treatment with anticoagulant drugs
- Treatment with intravenous bisphosphonates
- Treatment with anticonvulsants
- Patient's inability to maintain home hygiene standards in accordance with the study requirements
- History of drug and/or alcohol abuse
Show all 13Show fewer
- Chronic corticosteroid therapy
- Radiotherapy, chemotherapy and/or immunosuppressive treatment or radiotherapy in the last 5 years
- Psychosis
- Pregnant or breastfeeding
- Poor compliance
- Endocrinological disorders in poor pharmacological control
- Other uncontrolled systemic conditions that preclude performing surgical procedures
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, Milan, 20157
Alessandro Baj, Prof, 0039 3884214136, alessandro.baj@unimi.it
About this study
Official title: Splintless Virtual Surgical Plan with Mandible-first Technique in Orthognathic Surgery: Tridimensional Accuracy Analysis
Accuracy assessment through three-dimensional superposition of the post-operative volumetric CT and the digital therapeutic project files.
- Conditions
- Dentofacial Deformities
- Being tested
- Bimaxillary Osteotomy
- Medical subject headings
- Dentofacial Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bimaxillary OsteotomyProcedure or surgery
Maxillary LeFort I osteotomy and mandible osteotomy (BSSO) without intermediate splint.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy evaluation
3D superposition of post-operative volumetric CT and the digital therapeutic project files.
The variables and parameters analysis will be performed after the data distribution analysis, using the D'Agostino Pearson omnibus normality test: normal distribution data will be expressed as mean and standard deviation; non-normal distribution data will be expressed as median and interquartile range.
The quantitative and qualitative variables will be expressed in terms of absolute frequencies and percentage value.
Image superposition accuracy will be defined by measuring distances between the different anatomical reference points, considering excellent accuracy for distances less than 2 mm. Correlation and multivariate analysis models will be developed to define the secondary outcomes.
Measured: 1 month post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start24 Apr 2024
- Primary completion30 Sep 2024
- Study completion31 Dec 2025 (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
- Other
- Time perspective
- Other
- Enrolment
- 28 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907745
- Sponsor's protocol ID
- Mandible First
- Acronym
- MandiFirst
- Status last verified
- Jun 2024
- First submitted
- 18 May 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Scientific Pubblication
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Splintless Virtual Surgical Plan with Mandible-first Technique in Orthognathic Surgery: Tridimensional Accuracy Analysis
- ClinicalTrials.gov ID
- NCT06907745
- Acronym / sponsor ID
- MandiFirst / Mandible First
- Conditions
- Dentofacial Deformities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Apr 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.
Accuracy assessment through three-dimensional superposition of the post-operative volumetric CT and the digital therapeutic project files.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diagnosis of dentoskeletal disorders
Key inclusion criteria (5 listed)
- Men and women
- Age over 18 and under 60
- Diagnosis of dento-skeletal dysmorphosis involving the middle third and lower part of the face
- Patients with consent to surgery
- Patients in good general health according to the evaluation of the PI and on the basis of the anamnesis and clinical examination
Key exclusion criteria (13 listed)
- History of previous maxillomandibular fracture
- Treatment with anticoagulant drugs
- Treatment with intravenous bisphosphonates
- Treatment with anticonvulsants
- Patient's inability to maintain home hygiene standards in accordance with the study requirements
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 |
|---|---|---|
| Bimaxillary OsteotomyMaxillary LeFort I osteotomy and mandible osteotomy (BSSO) without intermediate splint. | Procedure or surgery | – |
Primary outcome
Accuracy evaluation
Time frame: 1 month post-op
3D superposition of post-operative volumetric CT and the digital therapeutic project files. The variables and parameters analysis will be performed after the data distribution analysis, using the D'Agostino Pearson omnibus normality test: normal distribution data will be expressed as mean and standard deviation; non-normal distribution data will be expressed as median and interquartile range. The quantitative and qualitative variables will be expressed in terms of absolute frequencies and percentage value. Image superposition accuracy will be defined by measuring distances between the different anatomical reference points, considering excellent accuracy for distances less than 2 mm. Correlation and multivariate analysis models will be developed to define the secondary outcomes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: Undecided. Scientific Pubblication
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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. This study is not recruiting at the moment.
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 I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 2 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Baj, Prof (00393884214136, alessandro.baj@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy evaluation (time frame: 1 month post-op). 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 2 Apr 2025.