Oral and Maxillofacial ConditionsBIO-MAXNCT07024251
BIOlogical Waste Sample Collection for Progress in Oral and MAXillofacial Research
An observational study of Oral and Maxillofacial Conditions, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
The BIO-MAX (BIOlogical waste sample collection for progress in oral and MAXillofacial research) study, led by IRCCS Ospedale Galeazzi-Sant'Ambrogio, is a five-year observational research project aimed at improving the understanding and treatment of oral and maxillofacial conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral and Maxillofacial Conditions
- Type of treatment
- Pill or oral medicine
- How many people
- 383 participants
- Where
- 1 siteItaly
- Study dates
- 16 May 2025to May 2030
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: After informed consent, eligible patients undergoing routine exams or elective oral and maxillofacial surgery will be enrolled for biological waste collection.
Who may be able to join
- males and females
- ≥18 years old
- patients undergoing either routine oral clinical examination or elective oral and maxillofacial surgery at IRCCS Ospedale Galeazzi - Sant'Ambrogio
Who cannot join
- <18 years old
- inability to sign the Informed Consent
- positivity to virological tests (HIV, HCV, HBV, TPHA), if serological analysis is required
- pregnancy and breast feeding with declaration of patient
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 Ospedale Galeazzi-Sant'Ambrogio
Milan, Italy, 20157
Chiara Giannasi, 00390283502257, chiara.giannasi@unimi.it
About this study
The BIO-MAX (BIOlogical waste sample collection for progress in oral and MAXillofacial research) study, led by IRCCS Ospedale Galeazzi-Sant'Ambrogio, is a five-year observational research project aimed at improving the understanding and treatment of oral and maxillofacial conditions.
Researchers are collecting and analyzing biological samples-such as saliva, blood, and tissues typically discarded during dental and surgical procedures-from adult patients visiting the hospital for oral exams or surgery. A key focus is the study of salivary irisin, a promising biomarker linked to diseases like diabetes and heart disease. By examining how irisin levels vary with age, gender, lifestyle, and oral health, the team hopes to establish baseline values and better understand its diagnostic potential.
In addition to irisin analysis, the study will explore other waste tissues to uncover disease mechanisms, identify new biomarkers, and test future therapies using patient-derived laboratory models. Overall, BIO-MAX seeks to enhance diagnostics, improve patient care, and pave the way for innovative treatments in oral and maxillofacial medicine.
- Conditions
- Oral and Maxillofacial Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing routine oral exams or elective oral and maxillofacial surgery. | Adult male and female patients (18+) undergoing oral exams or elective oral/maxillofacial surgery at IRCCS Galeazzi. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Irisin Concentration Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Description:
Salivary irisin concentration will be measured in all participants using a validated enzyme-linked immunosorbent assay (ELISA). Measurements will be reported in ng/mL, aiming to provide a comprehensive profile of salivary irisin levels in relation to demographic, lifestyle, medical, and health-related variables.
Additional details:
Irisin concentration data will be analyzed in relation to participant characteristics such as age (in years), gender, physical activity level, body mass index (BMI in kg/m²), oral health status (assessed through clinical dental examination), self-reported general health status, and current pharmacological treatments. These variables will serve as contextual covariates to explore associations and subgroup differences in irisin levels. Although some covariates involve quantitative measurements, they are not considered outcome measures and will be used solely to support interpretation of the primary outcome.
Measured: 5 years from first patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start16 May 2025
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral and Maxillofacial ConditionsStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 383 participants (estimated)
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
- NCT07024251
- Sponsor's protocol ID
- BIO-MAX
- Acronym
- BIO-MAX
- Status last verified
- Jun 2025
- First submitted
- 19 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOlogical Waste Sample Collection for Progress in Oral and MAXillofacial Research
- ClinicalTrials.gov ID
- NCT07024251
- Acronym / sponsor ID
- BIO-MAX / BIO-MAX
- Conditions
- Oral and Maxillofacial Conditions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 383 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 16 May 2025 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 17 Jun 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.
The BIO-MAX (BIOlogical waste sample collection for progress in oral and MAXillofacial research) study, led by IRCCS Ospedale Galeazzi-Sant'Ambrogio, is a five-year observational research project aimed at improving the understanding and treatment of oral and maxillofacial conditions.
Researchers are collecting and analyzing biological samples-such as saliva, blood, and tissues typically discarded during dental and surgical procedures-from adult patients visiting the hospital for oral exams or surgery. A key focus is the study of salivary irisin, a promising biomarker linked to diseases like diabetes and heart disease. By examining how irisin levels vary with age, gender, lifestyle, and oral health, the team hopes to establish baseline values and better understand its diagnostic potential.
In addition to irisin analysis, the study will explore other waste tissues to uncover disease mechanisms, identify new biomarkers, and test future therapies using patient-derived laboratory models. Overall, BIO-MAX seeks to enhance diagnostics, improve patient care, and pave the way for innovative treatments in oral and maxillofacial medicine.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing routine oral exams or elective oral and maxillofacial surgery. | – | –Adult male and female patients (18+) undergoing oral exams or elective oral/maxillofacial surgery at IRCCS Galeazzi. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- After informed consent, eligible patients undergoing routine exams or elective oral and maxillofacial surgery will be enrolled for biological waste collection.
Key inclusion criteria (3 listed)
- males and females
- ≥18 years old
- patients undergoing either routine oral clinical examination or elective oral and maxillofacial surgery at IRCCS Ospedale Galeazzi - Sant'Ambrogio
Key exclusion criteria (4 listed)
- <18 years old
- inability to sign the Informed Consent
- positivity to virological tests (HIV, HCV, HBV, TPHA), if serological analysis is required
- pregnancy and breast feeding with declaration of patient
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
Salivary Irisin Concentration Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Time frame: 5 years from first patient enrollment
Description: Salivary irisin concentration will be measured in all participants using a validated enzyme-linked immunosorbent assay (ELISA). Measurements will be reported in ng/mL, aiming to provide a comprehensive profile of salivary irisin levels in relation to demographic, lifestyle, medical, and health-related variables. Additional details: Irisin concentration data will be analyzed in relation to participant characteristics such as age (in years), gender, physical activity level, body mass index (BMI in kg/m²), oral health status (assessed through clinical dental examination), self-reported general health status, and current pharmacological treatments. These variables will serve as contextual covariates to explore associations and subgroup differences in irisin levels. Although some covariates involve quantitative measurements, they are not considered outcome measures and will be used solely to support interpretation of the primary outcome.
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 17 Jun 2025.
- Individual participant dataSharing planned: No
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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.
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 Oral and Maxillofacial Conditions, 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 3 inclusion and 4 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 17 Jun 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Irisin Concentration Measured by Enzyme-Linked Immunosorbent Assay (ELISA) (time frame: 5 years from first patient enrollment). 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 17 Jun 2025.