Speech Performance of Rugby Players When Using Different Types of Mouthguard

NCT ID: NCT04010500

Last Updated: 2019-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-18

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Speech

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Rugby Players

Group Type EXPERIMENTAL

no mouthguard

Intervention Type DEVICE

Control (not using mouthguard)

'boil and bite' mouthguard

Intervention Type 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

Intervention Type 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).

Interventions

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no mouthguard

Control (not using mouthguard)

Intervention Type 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.

Intervention Type 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).

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Amy Liew

OTHER

Sponsor Role lead

Responsible Party

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Amy Liew

Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Universiti Kebangsaan Malaysia

Kuala Lumpur, , Malaysia

Site Status

Countries

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Malaysia

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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UKMPPI/111/8/JEP-2018-278

Identifier Type: -

Identifier Source: org_study_id

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