Oral microbiome Oral Health
Conditions
Interventions
This is an observational study. Fifty healthy adult subjects with no systemic or oral disease will be recruited.
The study design was chosen according to the current standards for obse
screening and entry into study
baseline data collection, including full periodontal charting (full-mouth PD, BOP, O’Leary PCR)
identification of sampling sites
sampling collection.
j. All clinical assessment data will be recorded via hard copy CRFs. CRFs will be submitted to the microbiological testing site for entry into the statistical dat
Sponsors
CIAS - University of Ferrara
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants of the study will be enrolled among healthy subjects at the Dentistry Section of the University of Ferrara. Eligible subjects will have the following characteristics: 1. Age 18-75 years 2. Both genders 3. Good general health conditions 4. Absence of oral pathologies 5. Willing to cooperate to guarantee participation to all planned experimental procedures, and for the whole duration of the study 6. Ability to understand and give informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnancy and breastfeeding 2. Systemic diseases, including diabetes, viral infections by HIV, HCV, genetic disorders, respiratory diseases (chronic bronchopneumopathy, asthma) 3. Chemotherapy or radiotherapy 4. Presence of orthodontic devices 5. Presence of tumors or severe pathologies of soft tissues and oral cavity 6. Presence of tooth decay lesions, conservative or prosthetic devices potentially impeding the correct sampling procedures 7. Systemic therapy with antimicrobials/antibiotics in the previous 3 months and during all the study 8. Dental prophylaxis in the previous 3 months 9. Consumption of drugs potentially interfering with periodontal conditions and/or with recovery after periodontal treatment in the previous 3 months (i.e. corticosteroids, calcium antagonists, systemi antibiotics, etc)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characterization of the microbial communities colonizing the different anatomical sites of the oral cavity. Methods include two types of molecular analyses: 1) NGS, 2) quantitative real time PCR microarray. Measured at a single timepoint, as the study does not include a follow-up phase of enrolled subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| The optimal methodology for characterization of the oral microbiome, to define a gold standard method for microbiome analysis. Methods used include comparison of the different types of sampling (microbial collection by swabs, by periodontal curettes, or by saliva collection) and of molecular analyses (NGS, or quantitative real time PCR microarray). Measured at a single timepoint, as the study does not include a follow-up phase of enrolled subjects. | — |
Countries
Italy
Outcome results
None listed