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
About this trial
This is an interventional basic science trial for Mouth Breathing focused on measuring mouthguard, ventilation, anaerobic power, ergogenic effects
Eligibility Criteria
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
NCT ID
NCT02529020
First Posted
August 11, 2015
Last Updated
August 11, 2020
Sponsor
University Ramon Llull
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
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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
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Jaw Clenching on Anaerobic Ability and Ventilatory Flows
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