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Jaw Clenching on Anaerobic Ability and Ventilatory Flows

Primary Purpose

Mouth Breathing

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mouthguard
No mouthguard
Sponsored by
University Ramon Llull
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mouth Breathing focused on measuring mouthguard, ventilation, anaerobic power, ergogenic effects

Eligibility Criteria

19 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy physical active males

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Mouthguard

    No mouthguard

    Arm Description

    All subjects perform all tests wearing mouthguard.

    All subjects perform all tests without mouthguard

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 11, 2015
    Last Updated
    August 11, 2020
    Sponsor
    University Ramon Llull
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02529020
    Brief Title
    Jaw Clenching on Anaerobic Ability and Ventilatory Flows
    Official Title
    Acute Effects of Jaw Clenching Using a Customized Mouthguard on Anaerobic Ability and Ventilatory Flows
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Ramon Llull

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mouth Breathing
    Keywords
    mouthguard, ventilation, anaerobic power, ergogenic effects

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Investigator
    Allocation
    Non-Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mouthguard
    Arm Type
    Experimental
    Arm Description
    All subjects perform all tests wearing mouthguard.
    Arm Title
    No mouthguard
    Arm Type
    Experimental
    Arm Description
    All subjects perform all tests without mouthguard
    Intervention Type
    Device
    Intervention Name(s)
    Mouthguard
    Intervention Description
    Condition of wearing mouthguard
    Intervention Type
    Device
    Intervention Name(s)
    No mouthguard
    Intervention Description
    Condition without mouthguard
    Primary Outcome Measure Information:
    Title
    Changes in performance in Wingate test
    Description
    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)
    Title
    Changes in performance dynamics airflow measurements.
    Description
    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)

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy physical active males Exclusion Criteria: Acute or chronic injury that caused pain during testing procedures Temporomandibular joint disorders
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xavier Pujades, PHD
    Organizational Affiliation
    Vicedagà Facultat ciències de l'Esport Blanquerna
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25264671
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19583574
    Citation
    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.
    Results Reference
    background

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    Jaw Clenching on Anaerobic Ability and Ventilatory Flows

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