Mouth BreathingNCT02529020
Jaw Clenching on Anaerobic Ability and Ventilatory Flows
A study testing Mouthguard and No mouthguard in people with Mouth Breathing, run by University Ramon Llull.
Trial summary
The latest findings on the ergogenic effects of a dentistry-design, bite-aligning mouthpiece require additional research to assess its impact on anaerobic ability and ventilatory parameters. Read more about this study
- Who is it for?
- Ages 19 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Mouth Breathing
- What is being tested?
- Mouthguard and No mouthguard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Aug 2015
- 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 19 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy physical active males
Who cannot join
- Acute or chronic injury that caused pain during testing procedures
- Temporomandibular joint disorders
About this study
Official title: Acute Effects of Jaw Clenching Using a Customized Mouthguard on Anaerobic Ability and Ventilatory Flows
The latest findings on the ergogenic effects of a dentistry-design, bite-aligning mouthpiece require additional research to assess its impact on anaerobic ability and ventilatory parameters. This study was aimed at determining the ergogenic acute effects of wearing a custom-made mouthpiece on oral airflow dynamics, Wingate Test performance parameters.
Read the detailed description
The objectives of this study are to investigate the acute effects of a customized, bite-aligning mouthpiece on the different parameters assessed during a Wingate Test, as compared to clenching the jaw without a mouthpiece, in a physically-active, male population. The study also investigate the influence of wearing a mouthpiece on non-forced and forced airflow dynamics, as compared to open mouth and a jaw clenching without mouthpiece. Mouthpieces are made using a new scanning method that simplified the fitting process and lowered its cost.
A nonrandomized study was designed to compare the effect of the occlusion condition on the anaerobic power and airflow dynamics. Conditions of wearing or not wearing mouthguard (MOUTHG and NO-MOUTHG, respectively) are randomly distributed in all tests. Each subject participate in three sessions. The first session is used to obtain informed consent assess anthropometric measurements and to scan the subject's mouth structure. In the second session, subjects are familiarized with the test protocols via a learning session that included demonstration of Wingate Test and the airflow dynamics measurements. Subjects also perform the airflow tests and the first Wingate Test trial. In the third session, subjects perform the second Wingate Test trial. Conditions are randomly distributed in all tests. Wingate Test trials were separated by three days and subjects were not allowed to perform intensive training workloads.
- Conditions
- Mouth Breathing
- Being tested
- Mouthguard, No mouthguard
- Keywords
- mouthguard, ventilation, anaerobic power, ergogenic effects
- Medical subject headings
- Mouth Breathing, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MouthguardDevice
Condition of wearing mouthguard
No mouthguardDevice
Condition without mouthguard
| Study group | Role | What they receive |
|---|---|---|
| Mouthguard | Experimental | All subjects perform all tests wearing mouthguard. Receives: Device: Mouthguard |
| No mouthguard | Experimental | All subjects perform all tests without mouthguard Receives: Device: No mouthguard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in performance in Wingate test
Anaerobic power and capacity are assessed using the Wingate test with and without mouthguard (MOUTHG and NO-MOUTHG, respectively). Subjects complete a 30-sec maximal effort on an ergometer at a resistance equivalent to 7.5% of their body mass. The ergometer is interfaced with a computer loaded with software (Wingate Software Version 1.11, Lode BV) that apply the appropriate load for each subject. As a warm-up procedure, subjects are instructed to begin pedaling for 5 minutes at 100 W and approximately 60 rpm. After a 5 second count down and without altering the mentioned parameters, subjects are asked to begin pedaling as fast as possible while receiving verbal encouragement throughout the test. Peak power (W) and mean power (W) are calculated and recorded in an online data acquisition system.
Measured: 3 trials spaced 48 hours (each trial 30 seconds)
Changes in performance dynamics airflow measurements.
Subjects are asked to breath at resting pace during 30-sec under three different conditions: open mouth without mouthguard, jaw clenching without mouthguard and jaw clenched with mouthguard (OMNM, JCNM and JCM, respectively). Subjects intercalate 30 second forced breathings under the same conditions. Rest time was 3 minutes after both measurements under each condition. Conditions are randomly distributed. Facemask and is connected to a Biopac MP100 system through the wide-range airflow transducer amplifier. Peak air flow is detected and mean air flow during the 30 second interval is calculated for all conditions in L•min-1.
Measured: 3 trials spaced 3 minutes (each trial 30 seconds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startMay 2014
- Primary completionJul 2015
- Study completionAug 2015
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 Mouth BreathingStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ramon Llull
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Morales, University Ramon Llull
- Investigators
- Xavier Pujades, PHD, Study chair, Vicedagà Facultat ciències de l'Esport Blanquerna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529020
- Sponsor's protocol ID
- mou01
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2015
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Arent, S. M., McKenna, J.and Golem, D. L. (2010). Effects of a neuromuscular dentistry-designed mouthguard on muscular endurance and anaerobic power. Comparative Exercise Physiology, 7(02), 73-79.
Bailey SP, Willauer TJ, Balilionis G, Wilson LE, Salley JT, Bailey EK, Strickland TL. Effects of an over-the-counter vented mouthguard on cardiorespiratory responses to exercise and physical agility. J Strength Cond Res. 2015 Mar;29(3):678-84. doi: 10.1519/JSC.0000000000000668.
PubMed 25264671Cetin C, Kececi AD, Erdogan A, Baydar ML. Influence of custom-made mouth guards on strength, speed and anaerobic performance of taekwondo athletes. Dent Traumatol. 2009 Jun;25(3):272-6. doi: 10.1111/j.1600-9657.2009.00780.x.
PubMed 19583574
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Jaw Clenching Using a Customized Mouthguard on Anaerobic Ability and Ventilatory Flows
- ClinicalTrials.gov ID
- NCT02529020
- Acronym / sponsor ID
- mou01
- Conditions
- Mouth Breathing
- Keywords
- mouthguard, ventilation, anaerobic power, ergogenic effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Ramon LlullUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 19 Aug 2015 (estimated)
- 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.
The latest findings on the ergogenic effects of a dentistry-design, bite-aligning mouthpiece require additional research to assess its impact on anaerobic ability and ventilatory parameters. This study was aimed at determining the ergogenic acute effects of wearing a custom-made mouthpiece on oral airflow dynamics, Wingate Test performance parameters.
Detailed description
The objectives of this study are to investigate the acute effects of a customized, bite-aligning mouthpiece on the different parameters assessed during a Wingate Test, as compared to clenching the jaw without a mouthpiece, in a physically-active, male population. The study also investigate the influence of wearing a mouthpiece on non-forced and forced airflow dynamics, as compared to open mouth and a jaw clenching without mouthpiece. Mouthpieces are made using a new scanning method that simplified the fitting process and lowered its cost.
A nonrandomized study was designed to compare the effect of the occlusion condition on the anaerobic power and airflow dynamics. Conditions of wearing or not wearing mouthguard (MOUTHG and NO-MOUTHG, respectively) are randomly distributed in all tests. Each subject participate in three sessions. The first session is used to obtain informed consent assess anthropometric measurements and to scan the subject's mouth structure. In the second session, subjects are familiarized with the test protocols via a learning session that included demonstration of Wingate Test and the airflow dynamics measurements. Subjects also perform the airflow tests and the first Wingate Test trial. In the third session, subjects perform the second Wingate Test trial. Conditions are randomly distributed in all tests. Wingate Test trials were separated by three days and subjects were not allowed to perform intensive training workloads.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mouthguard | Experimental | Device: MouthguardAll subjects perform all tests wearing mouthguard. |
| No mouthguard | Experimental | Device: No mouthguardAll subjects perform all tests without mouthguard |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy physical active males
Key exclusion criteria (2 listed)
- Acute or chronic injury that caused pain during testing procedures
- Temporomandibular joint disorders
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 |
|---|---|---|
| MouthguardCondition of wearing mouthguard | Device | Mouthguard |
| No mouthguardCondition without mouthguard | Device | No mouthguard |
Primary outcome
Changes in performance in Wingate test
Time frame: 3 trials spaced 48 hours (each trial 30 seconds)
Anaerobic power and capacity are assessed using the Wingate test with and without mouthguard (MOUTHG and NO-MOUTHG, respectively). Subjects complete a 30-sec maximal effort on an ergometer at a resistance equivalent to 7.5% of their body mass. The ergometer is interfaced with a computer loaded with software (Wingate Software Version 1.11, Lode BV) that apply the appropriate load for each subject. As a warm-up procedure, subjects are instructed to begin pedaling for 5 minutes at 100 W and approximately 60 rpm. After a 5 second count down and without altering the mentioned parameters, subjects are asked to begin pedaling as fast as possible while receiving verbal encouragement throughout the test. Peak power (W) and mean power (W) are calculated and recorded in an online data acquisition system.
Changes in performance dynamics airflow measurements.
Time frame: 3 trials spaced 3 minutes (each trial 30 seconds)
Subjects are asked to breath at resting pace during 30-sec under three different conditions: open mouth without mouthguard, jaw clenching without mouthguard and jaw clenched with mouthguard (OMNM, JCNM and JCM, respectively). Subjects intercalate 30 second forced breathings under the same conditions. Rest time was 3 minutes after both measurements under each condition. Conditions are randomly distributed. Facemask and is connected to a Biopac MP100 system through the wide-range airflow transducer amplifier. Peak air flow is detected and mean air flow during the 30 second interval is calculated for all conditions in L•min-1.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- BackgroundArent, S. M., McKenna, J.and Golem, D. L. (2010). Effects of a neuromuscular dentistry-designed mouthguard on muscular endurance and anaerobic power. Comparative Exercise Physiology, 7(02), 73-79.
- Background: PubMed 25264671Bailey SP, Willauer TJ, Balilionis G, Wilson LE, Salley JT, Bailey EK, Strickland TL. Effects of an over-the-counter vented mouthguard on cardiorespiratory responses to exercise and physical agility. J Strength Cond Res. 2015 Mar;29(3):678-84. doi: 10.1519/JSC.0000000000000668.
- Background: PubMed 19583574Cetin C, Kececi AD, Erdogan A, Baydar ML. Influence of custom-made mouth guards on strength, speed and anaerobic performance of taekwondo athletes. Dent Traumatol. 2009 Jun;25(3):272-6. doi: 10.1111/j.1600-9657.2009.00780.x.
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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.
Xavier Pujades, PHD study chair
Vicedagà Facultat ciències de l'Esport Blanquerna
Questions about this trial
What is this clinical trial studying?
A study testing Mouthguard and No mouthguard in people with Mouth Breathing, run by University Ramon Llull.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in performance in Wingate test (time frame: 3 trials spaced 48 hours (each trial 30 seconds)). The study lists 2 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 NCT02529020, 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 13 Aug 2020.