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Impact of 3D-Printed and Custom Mouthguards on Speech and Oral Functions in Children Practicing Contact Sports

NCT06972823 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-15

No results posted yet for this study

Summary

This study aims to compare the effects of traditional and 3D-printed custom-made mouthguards on speech and oral functions in pediatric cases who practice contact sports by evaluating the comfort, fit, and performance of both types of mouthguard fabrication methods. The study will be conducted on 60 children who practice contact sports, and the changes in speech, oral functions, the occlusal thickness of the mouthguards, and the cost efficiency will be assessed over a period of one year.

Conditions

  • Mouthguard Use
  • Orofacial Injuries Prevention
  • 3D Printed Mouthguard
  • Traditional Custom-made Mouthguard
  • Speech and Oral Functions

Interventions

DEVICE

3D printed custom-made mouthguards

Participants in the first group will receive 3D printed custom-made mouthguards

DEVICE

Traditional custom-made mouthguards

Participants in the active comparator arm will receive traditional custom-made mouthguards as an intervention

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Gihan M Abuelniel, Doctoral Degree (Professor) · Cairo University

  • Passant Nagi, Master's Degree · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2026-02-28
Completion
2026-08-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06972823 on ClinicalTrials.gov