Collection of biological waste samples to advance oral and maxillofacial care
BIOlogical Waste Sample Collection for Progress in Oral and MAXillofacial Research
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 |
|---|---|
| Enrollment | 383 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Locations | 1 site (Milan, Italy) |
| Trial ID | NCT07024251 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Milan, Italy
- IRCCS Ospedale Galeazzi-Sant'Ambrogio — Milan, Italy, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.