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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04251858
Other study ID # SantosMU8
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date March 30, 2019
Est. completion date December 30, 2022

Study information

Verified date May 2021
Source Universidade Metropolitana de Santos
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 120
Est. completion date December 30, 2022
Est. primary completion date November 10, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Brazil Caio Vinicius Gonçalves Roman Torres Santos SP

Sponsors (1)

Lead Sponsor Collaborator
Universidade Metropolitana de Santos

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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

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. — View Citation

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 dentist — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Probing depth Evaluation of Probing depth, from the gingival margin to the end of the periodontal sulcus 90 days
Primary Clinical attachment level evaluation of clinical attachment level, from the enamel cementum junction to the end of the periodontal sulcus 90 days
Primary Gingival index evaluation of bleeding on probing 90 days
Primary Plaque index evaluation of the accumulation of bacterial plaque around the teeth 90 days
Primary DMF index evaluation of teeth decayed, missed or filled 90 days
Primary Aerobic running performance evaluation test Run of 100 meters and time obtained in seconds and thousands of a second 90 days
Primary critical speed in swimming swim 25 meters, time measured in minutes and seconds 90 days
Primary Body mass index The BMI calculation must be done using the following mathematical formula: Weight ÷ height x height. 90 days
Primary 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
Primary 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
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