Evaluation of Oral Condition and the Effect of Dental Treatment on Physical Parameters of Athletes
Primary Purpose
Periodontal Diseases, Inflammation Gum, Caries,Dental
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dental Scaling
Oral hygiene instruction
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases focused on measuring Periodontal Diseases, Athletes, Caries, dental, Periodontal index
Eligibility 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.
Sites / Locations
- Caio Vinicius Gonçalves Roman Torres
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Athletes with oral problems
Athletes without oral problems
Arm Description
Athletes with periodontal diseases or gingivitis
Athletes diagnosed without oral problems
Outcomes
Primary Outcome Measures
Probing depth
Evaluation of Probing depth, from the gingival margin to the end of the periodontal sulcus
Clinical attachment level
evaluation of clinical attachment level, from the enamel cementum junction to the end of the periodontal sulcus
Gingival index
evaluation of bleeding on probing
Plaque index
evaluation of the accumulation of bacterial plaque around the teeth
DMF index
evaluation of teeth decayed, missed or filled
Aerobic running performance evaluation test
Run of 100 meters and time obtained in seconds and thousands of a second
critical speed in swimming
swim 25 meters, time measured in minutes and seconds
Body mass index
The BMI calculation must be done using the following mathematical formula: Weight ÷ height x height.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04251858
First Posted
January 23, 2020
Last Updated
May 21, 2021
Sponsor
Universidade Metropolitana de Santos
1. Study Identification
Unique Protocol Identification Number
NCT04251858
Brief Title
Evaluation of Oral Condition and the Effect of Dental Treatment on Physical Parameters of Athletes
Official Title
Evaluation of Oral Condition and the Effect of Dental Treatment on Physical Parameters of Athletes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 30, 2019 (Actual)
Primary Completion Date
November 10, 2020 (Actual)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Metropolitana de Santos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Inflammation Gum, Caries,Dental
Keywords
Periodontal Diseases, Athletes, Caries, dental, Periodontal index
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Athletes with oral problems
Arm Type
Experimental
Arm Description
Athletes with periodontal diseases or gingivitis
Arm Title
Athletes without oral problems
Arm Type
No Intervention
Arm Description
Athletes diagnosed without oral problems
Intervention Type
Procedure
Intervention Name(s)
Dental Scaling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Oral hygiene instruction
Intervention Description
Oral hygiene instructions should be given to all study participants. Guidance on the most appropriate toothbrush, toothpaste and interproximal cleaning method.
Primary Outcome Measure Information:
Title
Probing depth
Description
Evaluation of Probing depth, from the gingival margin to the end of the periodontal sulcus
Time Frame
90 days
Title
Clinical attachment level
Description
evaluation of clinical attachment level, from the enamel cementum junction to the end of the periodontal sulcus
Time Frame
90 days
Title
Gingival index
Description
evaluation of bleeding on probing
Time Frame
90 days
Title
Plaque index
Description
evaluation of the accumulation of bacterial plaque around the teeth
Time Frame
90 days
Title
DMF index
Description
evaluation of teeth decayed, missed or filled
Time Frame
90 days
Title
Aerobic running performance evaluation test
Description
Run of 100 meters and time obtained in seconds and thousands of a second
Time Frame
90 days
Title
critical speed in swimming
Description
swim 25 meters, time measured in minutes and seconds
Time Frame
90 days
Title
Body mass index
Description
The BMI calculation must be done using the following mathematical formula: Weight ÷ height x height.
Time Frame
90 days
Title
Muscle strength through the 1RM test on the bench press
Description
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.
Time Frame
90 days
Title
short-term heart rate variability at rest
Description
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.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CAIO VINICIUS G ROMAN TORRES
Organizational Affiliation
University of Santo Amaro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caio Vinicius Gonçalves Roman Torres
City
Santos
State/Province
SP
ZIP/Postal Code
11015001
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27119757
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.
Results Reference
result
PubMed Identifier
26527674
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 dentists. Br J Sports Med. 2016 Jan;50(1):41-4. doi: 10.1136/bjsports-2015-094953. Epub 2015 Nov 2.
Results Reference
result
PubMed Identifier
26545270
Citation
Broad EM, Rye LA. Do current sports nutrition guidelines conflict with good oral health? Gen Dent. 2015 Nov-Dec;63(6):18-23.
Results Reference
result
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Evaluation of Oral Condition and the Effect of Dental Treatment on Physical Parameters of Athletes
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