NCT04251858

Brief Summary

It is essential that athletes have perfect general health. Oral health plays an important role in this healthy framework necessary so that the results that must be achieved by athletes are not influenced. Inflammatory and / or infectious processes such as periodontal disease, caries, or even joint problems such as temporomandibular joint dysfunction can affect performance or impair participation in training and competitions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 30, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2020

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

May 24, 2021

Status Verified

May 1, 2021

Enrollment Period

1.6 years

First QC Date

January 23, 2020

Last Update Submit

May 21, 2021

Conditions

Keywords

Periodontal DiseasesAthletesCaries, dentalPeriodontal index

Outcome Measures

Primary Outcomes (10)

  • Probing depth

    Evaluation of Probing depth, from the gingival margin to the end of the periodontal sulcus

    90 days

  • Clinical attachment level

    evaluation of clinical attachment level, from the enamel cementum junction to the end of the periodontal sulcus

    90 days

  • Gingival index

    evaluation of bleeding on probing

    90 days

  • Plaque index

    evaluation of the accumulation of bacterial plaque around the teeth

    90 days

  • DMF index

    evaluation of teeth decayed, missed or filled

    90 days

  • Aerobic running performance evaluation test

    Run of 100 meters and time obtained in seconds and thousands of a second

    90 days

  • critical speed in swimming

    swim 25 meters, time measured in minutes and seconds

    90 days

  • Body mass index

    The BMI calculation must be done using the following mathematical formula: Weight ÷ height x height.

    90 days

  • Muscle strength through the 1RM test on the bench press

    It is the maximum amount of weight lifted once while performing a standardized weightlifting exercise. To test 1 RM of a muscle group, such as elbow flexors or knee extensors, a weight is chosen at the exercise device, but below the individual's maximum lifting capacity. If a repetition is completed, weight is added to the exercise device. Until the maximum lifting capacity is launched.

    90 days

  • short-term heart rate variability at rest

    To measure heart rate variability, we will use Polar S810i® frequency meter to obtain RR interval series for each individual, at rest, for 5 minutes; posteriorly, analysis will be performed using linear and non-linear indices.

    90 days

Study Arms (2)

Athletes with oral problems

EXPERIMENTAL

Athletes with periodontal diseases or gingivitis

Procedure: Dental ScalingOther: Oral hygiene instruction

Athletes without oral problems

NO INTERVENTION

Athletes diagnosed without oral problems

Interventions

The individuals will be treated by a single periodontist and the scaling and root planing procedures will be performed on all teeth as follows: local anesthetic infiltrative type of the areas to be treated, dental and root scaling using Grace 5/6 carbon steel curettes, 11/12, 13/14 and MacCall 13/14, 17/18 curettes, according to their therapeutic indications. Polishing the quadrants treated with abrasive paste; oral hygiene instructions including Bass toothbrushing, dental floss and sometimes inter-dental brush.

Athletes with oral problems

Oral hygiene instructions should be given to all study participants. Guidance on the most appropriate toothbrush, toothpaste and interproximal cleaning method.

Athletes with oral problems

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Athletes from all sports,
  • Individuals with systemic pathologies, smokers, should be included in the study

You may not qualify if:

  • pregnancy or lactation, use of antibiotics in the last 3 months, phenytoin, calcium antagonists, cyclosporine or anti-inflammatory drugs one month before the initial consultation, use of oral or replacement contraceptives hormonal, periodontal treatment in the 6 months prior to the start of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caio Vinicius Gonçalves Roman Torres

Santos, São Paulo, 11015001, Brazil

Location

Related Publications (3)

  • D'Ercole S, Tieri M, Martinelli D, Tripodi D. The effect of swimming on oral health status: competitive versus non-competitive athletes. J Appl Oral Sci. 2016 Apr;24(2):107-13. doi: 10.1590/1678-775720150324.

  • Needleman I, Ashley P, Meehan L, Petrie A, Weiler R, McNally S, Ayer C, Hanna R, Hunt I, Kell S, Ridgewell P, Taylor R. Poor oral health including active caries in 187 UK professional male football players: clinical dental examination performed by dentists. Br J Sports Med. 2016 Jan;50(1):41-4. doi: 10.1136/bjsports-2015-094953. Epub 2015 Nov 2.

  • Broad EM, Rye LA. Do current sports nutrition guidelines conflict with good oral health? Gen Dent. 2015 Nov-Dec;63(6):18-23.

MeSH Terms

Conditions

Periodontal DiseasesGingivitisDental Caries

Interventions

Dental Scaling

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesTooth DemineralizationTooth Diseases

Intervention Hierarchy (Ancestors)

Dental ProphylaxisPeriodonticsDentistryPreventive Dentistry

Study Officials

  • CAIO VINICIUS G ROMAN TORRES

    University of Santo Amaro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The groups of participants should be divided by the oral condition of the participants (with oral problems and without oral problems)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 23, 2020

First Posted

February 5, 2020

Study Start

March 30, 2019

Primary Completion

November 10, 2020

Study Completion

December 30, 2022

Last Updated

May 24, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations