Speech Performance of Rugby Players When Using Different Types of Mouthguard

Sponsor

Amy Liew (Other)

Overall Status

Completed

CT.gov ID

NCT04010500

Collaborator

(none)

Enrollment

Location

Arm

7.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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.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 :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Mean voice onset time [Immediate]
The delay between the start of the speech sound and the beginning of vocal cord vibration (in millisecond)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

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)