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NCT Number: NCT07024251

BIOlogical Waste Sample Collection for Progress in Oral and MAXillofacial Research

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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Key information

Conditions

Oral and Maxillofacial Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Italy, 20157

Location status: Recruiting

Location contact

Chiara Giannasi

CONTACT

[email protected]

00390283502257

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Other

Registry information

Acronym: BIO-MAX

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jun 17, 2025
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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