BIOlogical Waste Sample Collection for Progress in Oral and MAXillofacial Research
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Oral and Maxillofacial Conditions. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Salivary Irisin Concentration Measured by Enzyme-Linked Immunosorbent Assay (ELISA) [Time frame: 5 years from first patient enrollment]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
Italy · 1 center
- IRCCS Ospedale Galeazzi-Sant'Ambrogio — Milan
Identifiers
NCT: NCT07024251 · BIO-MAX