Speech Performance of Rugby Players When Using Different Types of Mouthguard
NCT ID: NCT04010500
Last Updated: 2019-07-08
Study Results
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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COMPLETED
NA
30 participants
INTERVENTIONAL
2018-05-18
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Rugby Players
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* currently representing the nation and participating actively in rugby
* native speakers of Malay (national language)
Exclusion Criteria
* 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)
18 Years
FEMALE
Yes
Sponsors
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Amy Liew
OTHER
Responsible Party
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Amy Liew
Lecturer
Locations
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Universiti Kebangsaan Malaysia
Kuala Lumpur, , Malaysia
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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UKMPPI/111/8/JEP-2018-278
Identifier Type: -
Identifier Source: org_study_id
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