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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years from first patient enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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After informed consent, eligible patients undergoing routine exams or elective oral and maxillofacial surgery will be enrolled for biological waste collection.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale Galeazzi-Sant'Ambrogio | Recruiting | Milan | Italy | 20157 | Italy |
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The study collects saliva (mandatory), crevicular fluid, gingival tissue, teeth, bone fragments, adipose tissue, blood, and intra-cystic fluid for analysis.