Collection of biological waste samples to advance oral and maxillofacial care
Official title: BIOlogical Waste Sample Collection for Progress in Oral and MAXillofacial Research
Run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · NCT07024251 · Data updated 2026-11-12
This project collects saliva, blood, and discarded tissue from adults having dental exams or oral and maxillofacial surgery to see if biomarkers like salivary irisin can help understand and diagnose oral and facial conditions.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 383 (estimated) |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Locations | 1 site (Milan, Italy) |
| Status | Recruiting |
| Started | May 16, 2025 |
| Main results expected | May 2030 |
| Study ends | May 2030 |
| Registry record updated | June 17, 2025 |
| Trial ID | NCT07024251 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who are attending IRCCS Ospedale Galeazzi–Sant'Ambrogio for routine oral examinations or elective oral and maxillofacial surgery and who can give informed consent are ideal candidates.
✕Probably not a fit
Patients under 18, those unable to provide informed consent, pregnant or breastfeeding individuals, and people with positive HIV/HCV/HBV/TPHA serology (if testing is required) are unlikely to participate or receive direct benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
BIO-MAX is a five-year observational program at IRCCS Ospedale Galeazzi–Sant'Ambrogio that gathers biological material normally discarded during dental visits and elective oral/maxillofacial surgery. Samples include saliva, blood, and surgical waste tissue, which will be analyzed for biomarkers with a primary focus on salivary irisin. Researchers will examine how irisin levels vary with age, sex, lifestyle, and oral health, and will also profile other tissues to uncover disease mechanisms. Collected materials may be used to identify new biomarkers and to develop patient-derived laboratory models for future therapeutic testing.
Why it matters
Potential benefit: If successful, this work could identify biomarkers such as salivary irisin that enable earlier diagnosis, improved monitoring, and more personalized care for oral and maxillofacial conditions.
How similar studies have gone: Collection of saliva and discarded surgical tissues has been used in other biomarker discovery efforts and early irisin research in metabolic and cardiovascular fields is promising, but applying irisin specifically to oral and maxillofacial conditions remains largely exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * \<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
Where it's running
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IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, Italy, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.