Effect of Digitally Produced Custom Mouthguards on the Awareness and Sports Performance of Child and Adolescent Basketball Players

January 28, 2025 updated by: Hüseyin Karayılmaz, Akdeniz University

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Individuals with mouth breathing,
  • Individuals with a history of adenoid vegetation or enlarged adenoids.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Yo-Yo performance test
Participants will undergo the Yo-Yo performance test both while using and not using mouthguards prepared with a digital workflow.
Device: Mouthguard
After the participants' records are taken with intraoral scanners, custom mouthguards will be prepared from soft EVA sheets in a dental laboratory setting.
Other: Performance test
Participants will undergo the Yo-Yo performance test both while using and not using mouthguards prepared with a digital workflow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of performance tests, up to 20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge, awareness, and views on mouthguards
Time Frame: Within 10 minutes after the performance test
Participants will complete a ...-item questionnaire regarding their knowledge, awareness, and views on mouthguards.
Within 10 minutes after the performance test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TDH-2024-6739

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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