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Comparative Assessment of Thickness Changes in 3D-Printed vs. Custom-Made Mouth Guards for Children in Contact Sports

NCT07000435 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-06-02

No results posted yet for this study

Summary

This study aims to compare changes in the thickness of traditional and 3D-printed custom mouth guards in pediatric athletes who participate in contact sports. Specifically, it will assess the occlusal thickness changes between both types of mouth guards. The research will involve 56 children engaged in contact sports, and the evaluation will cover occlusal thickness, speech, oral functions, and cost-effectiveness over the course of one yea

Conditions

  • Mouthguard Use Orofacial Injuries Prevention 3D Printed Mouthguard Traditional Custom-made Mouthguard Occlusal Thickness Changes

Interventions

DEVICE

3D printed custom-made mouth guards

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

DEVICE

Traditional custom-made mouth guards

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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Gihan Mohamed 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
2025-10-31
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 NCT07000435 on ClinicalTrials.gov