NCT04010500

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

8 months

First QC Date

June 28, 2019

Last Update Submit

July 2, 2019

Conditions

Keywords

dental traumarugbymouthguardspeechcontact sports

Outcome Measures

Primary Outcomes (1)

  • Mean voice onset time

    The delay between the start of the speech sound and the beginning of vocal cord vibration (in millisecond)

    Immediate

Study Arms (1)

Rugby Players

EXPERIMENTAL
Device: no mouthguardDevice: 'boil and bite' mouthguardDevice: custom-fitted mouthguard

Interventions

Control (not using mouthguard)

Rugby Players

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.

Rugby Players

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).

Rugby Players

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult female aged 18 years old and older
  • currently representing the nation and participating actively in rugby
  • native speakers of Malay (national language)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Kebangsaan Malaysia

Kuala Lumpur, 50300, Malaysia

Location

MeSH Terms

Conditions

Speech

Condition Hierarchy (Ancestors)

Verbal BehaviorCommunicationBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 28, 2019

First Posted

July 8, 2019

Study Start

May 18, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

July 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations