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Speech Performance of Rugby Players When Using Different Types of Mouthguard

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. Identifier: NCT04010500
Recruitment Status : Completed
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Information provided by (Responsible Party):
Amy Liew, Universiti Kebangsaan Malaysia Medical Centre

Brief Summary:
Participation in contact sports is linked to an increased risk of dental injuries. To reduce the risk and severity of sports-related dental injuries, mouthguards are often recommended to be worn during training and competition. However, athletes often complain that they cannot talk properly when using mouthguards. It is hypothesized that speech performance differs when using different types of mouthguards. A group of female national rugby players will be asked to pronounce four Malay words with plosive sounds (/p/, /b/, /d/ and /t/) repeatedly in three conditions: (i) when not using any mouthguard, (ii) when using 'boil and bite' mouthguard, and (iii) when using custom-fitted mouthguard. The sounds will be recorded for spectrographic analysis. The difference in mean voice onset time between conditions will be assessed.

Condition or disease Intervention/treatment Phase
Speech Device: no mouthguard Device: 'boil and bite' mouthguard Device: custom-fitted mouthguard Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The participants will articulate phonemes with plosive sounds (/p/, /b/, /d/ and /t/) for the following conditions in a pre-determined sequence: (i) not using mouthguard; (ii) using a 'boil and bite' mouthguard; and (iii) using a custom-fitted mouthguard. A washout interval of one hour will be implemented between conditions.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Speech Performance of Rugby Players When Using Different Types of Mouthguard
Actual Study Start Date : May 18, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: Rugby Players Device: no mouthguard
Control (not using mouthguard)

Device: 'boil and bite' mouthguard
KHZ058 Bicolor Mouth Guard (Shenzhen Kanghao Industrial Co. Ltd, China) will be immersed in a bowl of hot water (about 80 °C). After 50 seconds, the softened sheet will be fitted on the maxillary arch of the participant. The participant will then bite down to ensure the mouthguard stay firmly on the maxilla. After that, the mouthguard will be removed and immersed in cold water to retain its shape.

Device: custom-fitted mouthguard
The custom-fitted mouthguards will be constructed using the dual laminated technique with two layers of ethylene vinyl acetate (EVA) thermoplastic sheets (Dentsply International Raintree Essix, Court East Sarasota, USA).

Primary Outcome Measures :
  1. Mean voice onset time [ Time Frame: Immediate ]
    The delay between the start of the speech sound and the beginning of vocal cord vibration (in millisecond)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • adult female aged 18 years old and older
  • currently representing the nation and participating actively in rugby
  • native speakers of Malay (national language)

Exclusion Criteria:

  • did not play rugby within the last six months
  • edentulism
  • used a mouthguard, orthodontic appliance or removable prosthodontics appliance within the last six months
  • known history of allergy to polymers
  • medical problems (ASA classification 3 and above)

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 identifier (NCT number): NCT04010500

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Universiti Kebangsaan Malaysia
Kuala Lumpur, Malaysia, 50300
Sponsors and Collaborators
Amy Liew
  Study Documents (Full-Text)

Documents provided by Amy Liew, Universiti Kebangsaan Malaysia Medical Centre:
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Responsible Party: Amy Liew, Lecturer, Universiti Kebangsaan Malaysia Medical Centre Identifier: NCT04010500    
Other Study ID Numbers: UKMPPI/111/8/JEP-2018-278
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amy Liew, Universiti Kebangsaan Malaysia Medical Centre:
dental trauma
contact sports