Oral ManifestationsCM&BaseballNCT06840340
Customised Mouthguards on Baseball and Softball Performance
A study testing Customised mouthguards in people with Oral Manifestations and Control Condition, run by National Taiwan Sport University at 1 site in Taiwan.
Trial summary
Whether the use of customised mouthguards is effective in improving the athletic performance of baseball and softball performance Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Manifestations, Control Condition
- What is being tested?
- Customised mouthguards
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Feb 2024to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Concurrent Activiation Potentation Induced by Customized Mouth Guard on Baseball and Softball Performance
Whether the use of customised mouthguards is effective in improving the athletic performance of baseball and softball performance
Read the 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.
- Conditions
- Oral Manifestations, Control Condition
- Being tested
- Customised mouthguards
- Keywords
- concurrent activation potentiation, bite force
- Medical subject headings
- Oral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customised mouthguardsDevice
Wore customised mouthguards and measurement athletic performance of baseball and softball performance.
| Study group | Role | What they receive |
|---|---|---|
| Mouthguards | Experimental | Participants wore the mouthguard Receives: Device: Customised mouthguards |
| Control | No intervention | Participants did not ware the mouthguard |
What is being measured
The primary outcome is the main question the study is designed to answer.
exit velocity
Test the pitching or batting exit velocity
Measured: Immediately after wore customized mouthguard or not
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start20 Feb 2024
- Primary completion30 Sep 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral ManifestationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chih-Hui Chiu, National Taiwan Sport University
- Investigators
- Chih Hui Chiu, PhD, Principal investigator, National Taiwan University of Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840340
- Sponsor's protocol ID
- 114-1
- Other IDs
- 114-1
- Acronym
- CM&Baseball
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD sharing plan
Publications
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.
PubMed 40845272
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Concurrent Activiation Potentation Induced by Customized Mouth Guard on Baseball and Softball Performance
- ClinicalTrials.gov ID
- NCT06840340
- Acronym / sponsor ID
- CM&Baseball / 114-1
- Conditions
- Oral Manifestations, Control Condition
- Keywords
- concurrent activation potentiation, bite force
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Taiwan Sport UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mouthguards | Experimental | Device: Customised mouthguardsParticipants wore the mouthguard |
| Control | No intervention | –Participants did not ware the mouthguard |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Customised mouthguardsWore customised mouthguards and measurement athletic performance of baseball and softball performance. | Device | Mouthguards |
Primary outcome
exit velocity
Time frame: Immediately after wore customized mouthguard or not
Test the pitching or batting exit velocity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Derived from this study: PubMed 40845272Teng 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.
- Individual participant dataSharing planned: No. No IPD sharing plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chih Hui Chiu, PhD principal investigator
National Taiwan University of Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Customised mouthguards in people with Oral Manifestations and Control Condition, run by National Taiwan Sport University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exit velocity (time frame: Immediately after wore customized mouthguard or not). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06840340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.