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Completed

NCT Number: NCT04010500

Speech Performance of Rugby Players When Using Different Types of Mouthguard

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.

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Key information

Conditions

Speech Behavior Communication Verbal Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Kebangsaan Malaysia

Kuala Lumpur, 50300, Malaysia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

no mouthguard

Device

Control (not using mouthguard)

'boil and bite' mouthguard

Device

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

Device

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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Amy Liew

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 8, 2019
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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