Periodontal DiseasesNCT04251858
Evaluation of Oral Condition and the Effect of Dental Treatment on Physical Parameters of Athletes
A study testing Dental Scaling and Oral hygiene instruction in people with Periodontal Diseases and Inflammation Gum, run by Universidade Metropolitana de Santos at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Inflammation Gum, Caries,Dental
- What is being tested?
- Dental Scaling and Oral hygiene instruction
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Mar 2019to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Athletes from all sports,
- Individuals with systemic pathologies, smokers, should be included in the study
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Periodontal Diseases, Inflammation Gum, Caries,Dental
- Being tested
- Dental Scaling, Oral hygiene instruction
- Keywords
- Periodontal Diseases, Athletes, Caries, dental, Periodontal index
- Medical subject headings
- Periodontal Diseases, Gingivitis, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental ScalingProcedure or surgery
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 instructionOther
Oral hygiene instructions should be given to all study participants. Guidance on the most appropriate toothbrush, toothpaste and interproximal cleaning method.
| Study group | Role | What they receive |
|---|---|---|
| Athletes with oral problems | Experimental | Athletes with periodontal diseases or gingivitis Receives: Procedure: Dental Scaling; Other: Oral hygiene instruction |
| Athletes without oral problems | No intervention | Athletes diagnosed without oral problems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth
Evaluation of Probing depth, from the gingival margin to the end of the periodontal sulcus
Measured: 90 days
Clinical attachment level
evaluation of clinical attachment level, from the enamel cementum junction to the end of the periodontal sulcus
Measured: 90 days
Gingival index
evaluation of bleeding on probing
Measured: 90 days
Plaque index
evaluation of the accumulation of bacterial plaque around the teeth
Measured: 90 days
DMF index
evaluation of teeth decayed, missed or filled
Measured: 90 days
Aerobic running performance evaluation test
Run of 100 meters and time obtained in seconds and thousands of a second
Measured: 90 days
critical speed in swimming
swim 25 meters, time measured in minutes and seconds
Measured: 90 days
Body mass index
The BMI calculation must be done using the following mathematical formula: Weight ÷ height x height.
Measured: 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.
Measured: 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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start30 Mar 2019
- Primary completion10 Nov 2020
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Metropolitana de Santos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CAIO VINICIUS G. ROMAN TORRES, Universidade Metropolitana de Santos
- Investigators
- CAIO VINICIUS G ROMAN TORRES, Principal investigator, Universidade Santo Amaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251858
- Sponsor's protocol ID
- SantosMU8
- Status last verified
- May 2021
- First submitted
- 23 Jan 2020
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27119757Needleman 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.
PubMed 26527674Broad EM, Rye LA. Do current sports nutrition guidelines conflict with good oral health? Gen Dent. 2015 Nov-Dec;63(6):18-23.
PubMed 26545270
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral Condition and the Effect of Dental Treatment on Physical Parameters of Athletes
- ClinicalTrials.gov ID
- NCT04251858
- Acronym / sponsor ID
- SantosMU8
- Conditions
- Periodontal Diseases, Inflammation Gum, Caries,Dental
- Keywords
- Periodontal Diseases, Athletes, Caries, dental, Periodontal index
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universidade Metropolitana de SantosUniversity, hospital or other
- Study start
- 30 Mar 2019 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The groups of participants should be divided by the oral condition of the participants (with oral problems and without oral problems)
| Arm | Type | Receives |
|---|---|---|
| Athletes with oral problems | Experimental | Procedure: Dental Scaling, Other: Oral hygiene instructionAthletes with periodontal diseases or gingivitis |
| Athletes without oral problems | No intervention | –Athletes diagnosed without oral problems |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Athletes from all sports,
- Individuals with systemic pathologies, smokers, should be included in the study
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental ScalingThe 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. | Procedure or surgery | Athletes with oral problems |
| Oral hygiene instructionOral hygiene instructions should be given to all study participants. Guidance on the most appropriate toothbrush, toothpaste and interproximal cleaning method. | Other | Athletes with oral problems |
Primary outcome
Probing depth
Time frame: 90 days
Evaluation of Probing depth, from the gingival margin to the end of the periodontal sulcus
Clinical attachment level
Time frame: 90 days
evaluation of clinical attachment level, from the enamel cementum junction to the end of the periodontal sulcus
Gingival index
Time frame: 90 days
evaluation of bleeding on probing
Plaque index
Time frame: 90 days
evaluation of the accumulation of bacterial plaque around the teeth
DMF index
Time frame: 90 days
evaluation of teeth decayed, missed or filled
Aerobic running performance evaluation test
Time frame: 90 days
Run of 100 meters and time obtained in seconds and thousands of a second
critical speed in swimming
Time frame: 90 days
swim 25 meters, time measured in minutes and seconds
Body mass index
Time frame: 90 days
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
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Results publication: PubMed 27119757D'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 publication: PubMed 26527674Needleman 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 publication: PubMed 26545270Broad EM, Rye LA. Do current sports nutrition guidelines conflict with good oral health? Gen Dent. 2015 Nov-Dec;63(6):18-23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CAIO VINICIUS G ROMAN TORRES principal investigator
Universidade Santo Amaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Scaling and Oral hygiene instruction in people with Periodontal Diseases and Inflammation Gum, run by Universidade Metropolitana de Santos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth (time frame: 90 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04251858, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.