Speech Performance of Rugby Players When Using Different Types of Mouthguard

Speech Clinical Trial

Official title:

Speech Performance of Rugby Players When Using Different Types of Mouthguard

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04010500
• Other study ID #: UKMPPI/111/8/JEP-2018-278
• Status: Completed
• Phase: N/A
• Start date: May 18, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2019
• Source: Universiti Kebangsaan Malaysia Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Speech

Intervention

Device:
• no mouthguard
Control (not using mouthguard)
• '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.
• 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).

Locations

Country	Name	City	State
Malaysia	Universiti Kebangsaan Malaysia	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Amy Liew

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean voice onset time	The delay between the start of the speech sound and the beginning of vocal cord vibration (in millisecond)	Immediate