NCT05765422

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

3.4 years

First QC Date

March 1, 2023

Last Update Submit

May 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Quantification of salivary inflammatory markers in healthy individuals who perform endurance physical activity at different levels.

    3 years

Study Arms (3)

sedentary

OTHER

Participant does not meet WHO's recommendations with the physical activity

Other: salivar and gum sampling

OMS recommandations

OTHER

Participant does not meet WHO's recommendations (2.5-5 hours per week of moderate physical activity OR 1.25-2.5 hours per week of vigorous physical activity);

Other: salivar and gum sampling

More than the OMS recommandations

OTHER

Participant is practicing physical activity more than the WHO recommendations

Other: salivar and gum sampling

Interventions

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

More than the OMS recommandationsOMS recommandationssedentary

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be between 18 and 30 years old
  • If practicing sports, it must be an endurance sport as main activity (cycling or running)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nice University Hospital

Nice, 06000, France

RECRUITING

Related Publications (1)

  • Ortis M, Dubois M, Bougault V, Legueult K, Fassy J, Mari B, Bertrand MF, Lupi L, Doglio A. ORASPORT study protocol: a prospective observational study on the impact of endurance physical activity on oral microbiology and immunology. Front Oral Health. 2025 Dec 5;6:1692359. doi: 10.3389/froh.2025.1692359. eCollection 2025.

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 13, 2023

Study Start

October 17, 2022

Primary Completion

March 15, 2026

Study Completion

March 15, 2026

Last Updated

May 17, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations