Customised Mouthguards on Baseball and Softball Performance | NCT06840340

Studies
Customised Mouthguards on Baseball and Softball Performance

NCT06840340

Sponsor

National Taiwan Sport University

Status

Completed

Last Update Posted

Feb 21, 2025Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Oral Manifestations
Control Condition

Interventions

Customised mouthguards

Countries

Taiwan

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

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
114-1	Other Identifier	NTUS

Status Module

Record Verification Date

Feb 2025

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

Feb 20, 2024Actual

Primary Completion Date

Sep 30, 2024Actual

Completion Date

Dec 20, 2024Actual

First Submitted Date

Feb 17, 2025

First Submission Date that Met QC Criteria

Feb 17, 2025

First Posted Date

Feb 21, 2025Actual

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

Feb 17, 2025

Last Update Posted Date

Feb 21, 2025Actual

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

Whether the use of customised mouthguards is effective in improving the athletic performance of baseball and softball performance

Detailed Description

This study recruited 45 baseball and softball players, including 30 fielders and 15 pitchers. Using a randomized crossover experimental design, the study was divided into randomised divided into customised mouthguards trial (MG) and control trial (CON) without temporal positioning. After the participants wore the mouthguard, they performed the vertical jump and grip strength tests sequentially. At the end of the test, depending on the pitcher or fielder, a baseball pitching ability test or a hitting ability test was conducted using a radar baseball tracking system. It is expected to analyze the vertical jump height, grip strength, pitchers' straight and changeup ball speeds, rotation speeds, degree of displacement, on-base and off-base locations. Hitting ability was expected to be documented with respect to initial velocity, elevation, and consistency of elevation.

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

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mouthguards	Experimental	Participants wore the mouthguard	Device: Customised mouthguards
Control	No Intervention	Participants did not ware the mouthguard

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Customised mouthguards	Device	Wore customised mouthguards and measurement athletic performance of baseball and softball performance.	Mouthguards

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
exit velocity	Test the pitching or batting exit velocity	Immediately after wore customized mouthguard or not

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

has won the top 8 national level baseball of softball championships in the last three years.
no cardiovascular and joint diseases.
aged 20 or above who are adults
continuing to train professionally more than 5 days a week for the past year

Exclusion Criteria:

have not won the top 8 national baseball or softball championships in the past three years.
have a cardiovascular or joint disease, or any injuries that may be impaired by exercise.
participants who are underage or not in regular baseball or softball training
have injury to the temporomandibular joint.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chih Hui Chiu, PhD	National Taiwan University of Sport	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University of Sport		Taichung	North	404	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40845272	Derived	Teng NC, Hu YH, Wu TI, Shiu YJ, Yen CW, Chan WJ, Chiu CH. Biting on Customized Mouthguards Improves Vertical Jump and Slider Quality of Baseball Pitchers. J Strength Cond Res. 2025 Aug 13. doi: 10.1519/JSC.0000000000005233. Online ahead of print.

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms