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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05765422
Other study ID # 22-PP-11
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 17, 2022
Est. completion date March 15, 2026

Study information

Verified date May 2024
Source Centre Hospitalier Universitaire de Nice
Contact Margaux DUBOIS, PH
Phone 0489152267
Email Margaux.DUBOIS@univ-cotedazur.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The oral cavity is an easily accessible anatomical site that accurately reflects the health of the individual. The mouth is considered an early indicator of biological aging, leading to the identification of oral biomarkers predictive of future alterations. Current data show that the oral health of high level athletes is globally altered with an increase in cariogenic indexes, an increased incidence of periodontitis, dental trauma and dry mouth syndromes. Few studies have focused on the oral microbiota compared to mouthguards used in rugby or boxing which seem to induce dysbiosis, a recent study shows an effect of ketogenic diet on bacterial changes in the mouth of endurance athletes. This project focuses on the impact of intensive sport practice on oral health and the identification of oral biomarkers associated with physical activity. The objective of this study is to investigate the impact of the amount of endurance sport practice on oral microbiota and oral health in young adults. the hypothesis is that a sedentary lifestyle and high-level sport induce depletion and/or changes in the oral microbiota compared to regular physical activity.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date March 15, 2026
Est. primary completion date March 15, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - Be between 18 and 30 years old - If practicing sports, it must be an endurance sport as main activity (cycling or running) Exclusion Criteria: - Practice more than 3 hours of swimming per week - Have taken anti-inflammatory drugs, less than 48 hours before the study - Have taken antibiotics and/or probiotics, less than 3 weeks before the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
salivar and gum sampling
Saliva will then be collected by salivary spit and a mucosal smear will be taken using a swab passed at the junction of the tooth and the gum

Locations

Country Name City State
France Nice University Hospital Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Analysis of the oral microbiota in healthy individuals engaged in endurance physical activity at different levels. Microbiological screening will be performed using an innovative methodology based on microfluidic PCR (BiomarkHD) (number of bacterial colonies) 3 years
Secondary Quantification of salivary inflammatory markers in healthy individuals who perform endurance physical activity at different levels. numer and type of salivary inflammatory markers will performed using multiplex analysis technology developed by the firm Meso Scale Diagnostic (MSD). 3 years
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