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Evaluation of Oral Condition and the Effect of Dental Treatment on Physical Parameters of Athletes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251858
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
CAIO VINICIUS G. ROMAN TORRES, Universidade Metropolitana de Santos

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.

Condition or disease Intervention/treatment Phase
Periodontal Diseases Inflammation Gum Caries,Dental Procedure: Dental Scaling Other: Oral hygiene instruction Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The groups of participants should be divided by the oral condition of the participants (with oral problems and without oral problems)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Oral Condition and the Effect of Dental Treatment on Physical Parameters of Athletes
Actual Study Start Date : March 30, 2019
Estimated Primary Completion Date : November 10, 2020
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Experimental: Athletes with oral problems
Athletes with periodontal diseases or gingivitis
Procedure: Dental Scaling
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.

Other: Oral hygiene instruction
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



Primary Outcome Measures :
  1. Probing depth [ Time Frame: 90 days ]
    Evaluation of Probing depth, from the gingival margin to the end of the periodontal sulcus

  2. Clinical attachment level [ Time Frame: 90 days ]
    evaluation of clinical attachment level, from the enamel cementum junction to the end of the periodontal sulcus

  3. Gingival index [ Time Frame: 90 days ]
    evaluation of bleeding on probing

  4. Plaque index [ Time Frame: 90 days ]
    evaluation of the accumulation of bacterial plaque around the teeth

  5. DMF index [ Time Frame: 90 days ]
    evaluation of teeth decayed, missed or filled

  6. Aerobic running performance evaluation test [ Time Frame: 90 days ]
    Run of 100 meters and time obtained in seconds and thousands of a second

  7. critical speed in swimming [ Time Frame: 90 days ]
    swim 25 meters, time measured in minutes and seconds

  8. Body mass index [ Time Frame: 90 days ]
    The BMI calculation must be done using the following mathematical formula: Weight ÷ height x height.

  9. 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.

  10. 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.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251858


Contacts
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Contact: CAIO VINICIUS G ROMAN TORRES 13991304774 CVGRT@HOTMAIL.COM

Locations
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Brazil
Caio Vinicius Gonçalves Roman Torres Recruiting
Santos, SP, Brazil, 11015001
Contact: CAIO VINICIUS GONÇALVES R TORRES    13991304774    CVGRT@HOTMAIL.COM   
Sponsors and Collaborators
Universidade Metropolitana de Santos
Investigators
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Principal Investigator: CAIO VINICIUS G ROMAN TORRES University of Santo Amaro
  Study Documents (Full-Text)

Documents provided by CAIO VINICIUS G. ROMAN TORRES, Universidade Metropolitana de Santos:
Informed Consent Form  [PDF] August 9, 2018

Publications of Results:
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Responsible Party: CAIO VINICIUS G. ROMAN TORRES, Professor, Universidade Metropolitana de Santos
ClinicalTrials.gov Identifier: NCT04251858    
Other Study ID Numbers: SantosMU8
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CAIO VINICIUS G. ROMAN TORRES, Universidade Metropolitana de Santos:
Periodontal Diseases
Athletes
Caries, dental
Periodontal index
Additional relevant MeSH terms:
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Periodontal Diseases
Dental Caries
Gingivitis
Inflammation
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases
Gingival Diseases