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CompletedNCT02529020Updated Aug 13, 2020

Jaw Clenching on Anaerobic Ability and Ventilatory Flows

An interventional study of Mouthguard and No mouthguard in Mouth Breathing, sponsored by University Ramon Llull. Completed. Open to male participants aged 19 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-13.

Sponsored by University Ramon Llull · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
19 Years to 30 Years
Sex
Male
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Study 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. 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.

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Conditions studied

  • Mouth Breathing

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Keywords

  • mouthguard
  • ventilation
  • anaerobic power
  • ergogenic effects
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In context

Mouth Breathing

32 studies on the registry are indexed under Mouth Breathing; 5 are open to participants now.

This study's enrollment of 30 is below the median of 45 across 23 interventional studies indexed under Mouth Breathing.

Browse Mouth Breathing studies →

Lead sponsor

University Ramon Llull is the lead sponsor of 19 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy physical active males

Exclusion criteria

Exclusion Criteria:

  • Acute or chronic injury that caused pain during testing procedures
  • Temporomandibular joint disorders
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Mouthguard

    All subjects perform all tests wearing mouthguard.

    Device: Mouthguard

  • Experimental
    No mouthguard

    All subjects perform all tests without mouthguard

    Device: No mouthguard

Interventions

  • DeviceMouthguard

    Condition of wearing mouthguard

  • DeviceNo mouthguard

    Condition without mouthguard

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 trials spaced 48 hours (each trial 30 seconds)

  2. 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.

    Time frame: 3 trials spaced 3 minutes (each trial 30 seconds)

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Study locations

No study locations are listed for this record.

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References and documents

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 25264671 ↗
  • 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. PubMed 19583574 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02529020
Lead sponsor
University Ramon Llull
Responsible party
Jose Morales (PHD, University Ramon Llull) — Principal investigator
First posted
Aug 19, 2015
Start date
May 2014
Primary completion
Jul 2015
Completion
Aug 2015
Last update
Aug 13, 2020

Study contacts

Xavier Pujades, PHD
study chair · Vicedagà Facultat ciències de l'Esport Blanquerna

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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