Speech Performance of Rugby Players When Using Different... | NCT04010500

Studies
Speech Performance of Rugby Players When Using Different Types of Mouthguard

NCT04010500

Sponsor

Amy Liew

Status

Completed

Last Update Posted

Jul 8, 2019Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Speech

Interventions

no mouthguard
'boil and bite' mouthguard
custom-fitted mouthguard

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 18, 2018Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Jun 28, 2019

First Submission Date that Met QC Criteria

Jul 2, 2019

First Posted Date

Jul 8, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2019

Last Update Posted Date

Jul 8, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rugby Players	Experimental		Device: no mouthguard Device: 'boil and bite' mouthguard Device: custom-fitted mouthguard

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no mouthguard	Device	Control (not using mouthguard)	Rugby Players

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean voice onset time	The delay between the start of the speech sound and the beginning of vocal cord vibration (in millisecond)	Immediate

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universiti Kebangsaan Malaysia		Kuala Lumpur		50300	Malaysia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jul 10, 2019
Reset	Aug 15, 2019

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 18, 2018	Jul 2, 2019	Prot_SAP_000.pdf

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 10, 2019			Aug 15, 2019

Condition Browse Module

MeSH Terms

ID	Term
D013060	Speech

Ancestor Terms

ID	Term
D014705	Verbal Behavior
D003142	Communication
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

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.