- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02529020
Jaw Clenching on Anaerobic Ability and Ventilatory Flows
Acute Effects of Jaw Clenching Using a Customized Mouthguard on Anaerobic Ability and Ventilatory Flows
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy physical active males
Exclusion Criteria:
- Acute or chronic injury that caused pain during testing procedures
- Temporomandibular joint disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mouthguard
All subjects perform all tests wearing mouthguard.
|
Condition of wearing mouthguard
|
Experimental: No mouthguard
All subjects perform all tests without mouthguard
|
Condition without mouthguard
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 trials spaced 48 hours (each trial 30 seconds)
|
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.
|
3 trials spaced 3 minutes (each trial 30 seconds)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Xavier Pujades, PHD, Vicedagà Facultat ciències de l'Esport Blanquerna
Publications and helpful links
General 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.
- Cetin 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- mou01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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