Effect of Digitally Produced Custom Mouthguards on the Awareness and Sports Performance of Child and Adolescent Basketball Players
1 other identifier
interventional
80
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2025
Shorter than P25 for not_applicable
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
First Submitted
Initial submission to the registry
October 22, 2024
CompletedFirst Posted
Study publicly available on registry
October 28, 2024
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedJanuary 29, 2025
October 1, 2024
3 months
October 22, 2024
January 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From enrollment to the end of performance tests, up to 20 weeks
Secondary Outcomes (1)
Knowledge, awareness, and views on mouthguards
Within 10 minutes after the performance test
Study Arms (1)
Yo-Yo performance test
OTHERParticipants will undergo the Yo-Yo performance test both while using and not using mouthguards prepared with a digital workflow.
Interventions
After the participants' records are taken with intraoral scanners, custom mouthguards will be prepared from soft EVA sheets in a dental laboratory setting.
Participants will undergo the Yo-Yo performance test both while using and not using mouthguards prepared with a digital workflow.
Eligibility Criteria
You may qualify if:
- 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,
- 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.
You may not qualify if:
- Individuals with mouth breathing,
- Individuals with a history of adenoid vegetation or enlarged adenoids.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 22, 2024
First Posted
October 28, 2024
Study Start
March 1, 2025
Primary Completion
June 1, 2025
Study Completion
October 1, 2025
Last Updated
January 29, 2025
Record last verified: 2024-10