BIOlogical Waste Sample Collection for Progress in Oral and MAXillofacial Research

NCT07024251 | Recruiting

• 1 other identifier: BIO-MAX
• Study Type: observational
• Target: 383
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral and Maxillofacial Conditions

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

After informed consent, eligible patients undergoing routine exams or elective oral and maxillofacial surgery will be enrolled for biological waste collection.

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Italy, 20157, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The study collects saliva (mandatory), crevicular fluid, gingival tissue, teeth, bone fragments, adipose tissue, blood, and intra-cystic fluid for analysis.

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 17, 2025
• Study Start: May 16, 2025
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)