- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04251858
Evaluation of Oral Condition and the Effect of Dental Treatment on Physical Parameters of Athletes
May 21, 2021 updated by: CAIO VINICIUS G. ROMAN TORRES, Universidade Metropolitana de Santos
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
The objective of this longitudinal clinical study will be to evaluate the effect of dental treatment on individuals who practice physical activities through physical parameters of strength, speed and resistance.
According to an initial survey, about 120 individuals should be examined.
Clinical parameters such as decayed, lost and / or filled dental index and periodontal parameters such as probing depth (PS), clinical level of insertion (NCI), plaque index (IP) and bleeding index (IS) will be evaluated .
Physical tests of strength, speed and resistance should be performed and periodontal therapy should be performed according to the needs presented by each individual.
After 90 days, new clinical examinations and physical tests should be performed.
The results obtained should be tabulated and analyzed.
The investigators believe that individuals with oral inflammation / infection, the physical performance should be higher after performing periodontal therapy.
Pro inflammatory cytokines present in high concentrations in the presence of periodontal disease can influence fatigue and difficulty in recovering from injuries, variables so important in an athlete's life.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
Santos, SP, Brazil, 11015001
- Caio Vinicius Gonçalves Roman Torres
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Athletes from all sports,
- Individuals with systemic pathologies, smokers, should be included in the study
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Athletes with oral problems
Athletes with periodontal diseases or gingivitis
|
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.
Oral hygiene instructions should be given to all study participants.
Guidance on the most appropriate toothbrush, toothpaste and interproximal cleaning method.
|
NO_INTERVENTION: Athletes without oral problems
Athletes diagnosed without oral problems
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Probing depth
Time Frame: 90 days
|
Evaluation of Probing depth, from the gingival margin to the end of the periodontal sulcus
|
90 days
|
Clinical attachment level
Time Frame: 90 days
|
evaluation of clinical attachment level, from the enamel cementum junction to the end of the periodontal sulcus
|
90 days
|
Gingival index
Time Frame: 90 days
|
evaluation of bleeding on probing
|
90 days
|
Plaque index
Time Frame: 90 days
|
evaluation of the accumulation of bacterial plaque around the teeth
|
90 days
|
DMF index
Time Frame: 90 days
|
evaluation of teeth decayed, missed or filled
|
90 days
|
Aerobic running performance evaluation test
Time Frame: 90 days
|
Run of 100 meters and time obtained in seconds and thousands of a second
|
90 days
|
critical speed in swimming
Time Frame: 90 days
|
swim 25 meters, time measured in minutes and seconds
|
90 days
|
Body mass index
Time Frame: 90 days
|
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
Time Frame: 90 days
|
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
Time Frame: 90 days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 30, 2019
Primary Completion (ACTUAL)
November 10, 2020
Study Completion (ANTICIPATED)
December 30, 2022
Study Registration Dates
First Submitted
January 23, 2020
First Submitted That Met QC Criteria
January 30, 2020
First Posted (ACTUAL)
February 5, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 24, 2021
Last Update Submitted That Met QC Criteria
May 21, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SantosMU8
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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