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Jaw Clenching on Anaerobic Ability and Ventilatory Flows

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02529020
First Posted: August 19, 2015
Last Update Posted: August 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jose Morales, University Ramon Llull
  Purpose
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.

Condition Intervention
Mouth Breathing Device: Mouthguard Device: No mouthguard

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Acute Effects of Jaw Clenching Using a Customized Mouthguard on Anaerobic Ability and Ventilatory Flows

Further study details as provided by Jose Morales, University Ramon Llull:

Primary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: May 2014
Study Completion Date: August 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mouthguard
All subjects perform all tests wearing mouthguard.
Device: Mouthguard
Condition of wearing mouthguard
Experimental: No mouthguard
All subjects perform all tests without mouthguard
Device: No mouthguard
Condition without mouthguard

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy physical active males

Exclusion Criteria:

  • Acute or chronic injury that caused pain during testing procedures
  • Temporomandibular joint disorders
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529020


Sponsors and Collaborators
University Ramon Llull
Investigators
Study Chair: Xavier Pujades, PHD Vicedagà Facultat ciències de l'Esport Blanquerna
  More Information

Publications:
Responsible Party: Jose Morales, PHD, University Ramon Llull
ClinicalTrials.gov Identifier: NCT02529020     History of Changes
Other Study ID Numbers: mou01
First Submitted: August 11, 2015
First Posted: August 19, 2015
Last Update Posted: August 19, 2015
Last Verified: August 2015

Keywords provided by Jose Morales, University Ramon Llull:
mouthguard
ventilation
anaerobic power
ergogenic effects

Additional relevant MeSH terms:
Mouth Breathing
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms