Speech Performance of Rugby Players When Using Different Types of Mouthguard
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedFirst Submitted
Initial submission to the registry
June 28, 2019
CompletedFirst Posted
Study publicly available on registry
July 8, 2019
CompletedJuly 8, 2019
July 1, 2019
8 months
June 28, 2019
July 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean voice onset time
The delay between the start of the speech sound and the beginning of vocal cord vibration (in millisecond)
Immediate
Study Arms (1)
Rugby Players
EXPERIMENTALInterventions
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.
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).
Eligibility Criteria
You may qualify if:
- adult female aged 18 years old and older
- currently representing the nation and participating actively in rugby
- native speakers of Malay (national language)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amy Liewlead
Study Sites (1)
Universiti Kebangsaan Malaysia
Kuala Lumpur, 50300, Malaysia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
June 28, 2019
First Posted
July 8, 2019
Study Start
May 18, 2018
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
July 8, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share