Sports Performance in ChildrenNCT06660836
Effect of Digitally Produced Custom Mouthguards on the Awareness and Sports Performance of Child and Adolescent Basketball Players
A study testing Mouthguard and Performance test in people with Sports Performance in Children, run by Akdeniz University.
Trial summary
The aim of the study is to investigate the effects of custom mouthguards, prepared using digital workflow, on the sports performance of children and adolescents who play basketball, and to evaluate their views on the use of mouthguards. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sports Performance in Children
- What is being tested?
- Mouthguard and Performance test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Oct 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Involved in basketball for at least one year,
- Amateur or semi-professional athletes,
- Possession of a health report confirming eligibility for high-activity sports,
- No severe skeletal or dental anomalies,
- Class I occlusion relationship,
- No or mild dental crowding issues,
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- No severe nasal deviation that would interfere with sports,
- No prior use of any type of mouthguard,
- Training 4-5 days a week and actively competing in a basketball league.
Who cannot join
- Individuals with mouth breathing,
- Individuals with a history of adenoid vegetation or enlarged adenoids.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of the study is to investigate the effects of custom mouthguards, prepared using digital workflow, on the sports performance of children and adolescents who play basketball, and to evaluate their views on the use of mouthguards.
Do digitally produced custom mouthguards have an effect on the sports performance of child and adolescent basketball players?
Will the awareness and opinions of child and adolescent basketball players regarding mouthguards be affected?
Participants will:
Undergo the Yo-Yo performance test both while using and not using mouthguards prepared with a digital workflow.
- Conditions
- Sports Performance in Children
- Being tested
- Mouthguard, Performance test
- Keywords
- mouthguard, digital workflow, sports performance, protective equipment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MouthguardDevice
After the participants' records are taken with intraoral scanners, custom mouthguards will be prepared from soft EVA sheets in a dental laboratory setting.
Performance testOther
Participants will undergo the Yo-Yo performance test both while using and not using mouthguards prepared with a digital workflow.
| Study group | Role | What they receive |
|---|---|---|
| Yo-Yo performance test | Other | Participants will undergo the Yo-Yo performance test both while using and not using mouthguards prepared with a digital workflow. Receives: Device: Mouthguard; Other: Performance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of custom mouthguards on sports performance of child and adolescent basketball players
Effects of custom mouthguards on sports performance of child and adolescent basketball players will be evaluated by a performance test.
Measured: From enrollment to the end of performance tests, up to 20 weeks
Secondary outcomes (1)
Knowledge, awareness, and views on mouthguards
Participants will complete a ...-item questionnaire regarding their knowledge, awareness, and views on mouthguards.
Measured: Within 10 minutes after the performance test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study startMar 2025 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Performance in ChildrenStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hüseyin Karayılmaz, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660836
- Sponsor's protocol ID
- TDH-2024-6739
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Digitally Produced Custom Mouthguards on the Awareness and Sports Performance of Child and Adolescent Basketball Players
- ClinicalTrials.gov ID
- NCT06660836
- Acronym / sponsor ID
- TDH-2024-6739
- Conditions
- Sports Performance in Children
- Keywords
- mouthguard, digital workflow, sports performance, protective equipment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 28 Oct 2024 (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.
The aim of the study is to investigate the effects of custom mouthguards, prepared using digital workflow, on the sports performance of children and adolescents who play basketball, and to evaluate their views on the use of mouthguards.
Do digitally produced custom mouthguards have an effect on the sports performance of child and adolescent basketball players?
Will the awareness and opinions of child and adolescent basketball players regarding mouthguards be affected?
Participants will:
Undergo the Yo-Yo performance test both while using and not using mouthguards prepared with a digital workflow.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yo-Yo performance test | Other | Device: Mouthguard, Other: Performance testParticipants will undergo the Yo-Yo performance test both while using and not using mouthguards prepared with a digital workflow. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Involved in basketball for at least one year,
- Amateur or semi-professional athletes,
- Possession of a health report confirming eligibility for high-activity sports,
- No severe skeletal or dental anomalies,
- Class I occlusion relationship,
Key exclusion criteria (2 listed)
- Individuals with mouth breathing,
- Individuals with a history of adenoid vegetation or enlarged adenoids.
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 |
|---|---|---|
| MouthguardAfter the participants' records are taken with intraoral scanners, custom mouthguards will be prepared from soft EVA sheets in a dental laboratory setting. | Device | Yo-Yo performance test |
| Performance testParticipants will undergo the Yo-Yo performance test both while using and not using mouthguards prepared with a digital workflow. | Other | Yo-Yo performance test |
Primary outcome
Effects of custom mouthguards on sports performance of child and adolescent basketball players
Time frame: From enrollment to the end of performance tests, up to 20 weeks
Effects of custom mouthguards on sports performance of child and adolescent basketball players will be evaluated by a performance test.
1 secondary outcome
Knowledge, awareness, and views on mouthguards
Time frame: Within 10 minutes after the performance test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Sports Performance in Children
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Children Soccer Players
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.
Questions about this trial
What is this clinical trial studying?
A study testing Mouthguard and Performance test in people with Sports Performance in Children, run by Akdeniz University.
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 9 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Cengiz (+905313890830, dt.aysecengiz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of custom mouthguards on sports performance of child and adolescent basketball players (time frame: From enrollment to the end of performance tests, up to 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2025.