NCT07000435

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

Assessing Thickness Changes Following the Use of 3D-Printed Vs. Custom-Made Mouth Guards to Prevent Traumatic Dental Injuries in Children Practicing Contact Sports: A Randomized Clinical Trial.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 8 Years – 14 Years
• Healthy volunteers: Accepted

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

Detailed description

This randomized clinical trial will be conducted at Cairo International Stadium, involving healthy children aged 8 to 14 who actively participate in contact sports and require mouthguards for safety. Participants must be physically fit and cooperative. With parental consent, they will be randomly assigned in a 1:1 ratio to one of two groups: Group 1: Receives traditional custom-made mouthguards made from alginate impressions. Group 2: Receives 3D-printed custom-made mouthguards created using digital intraoral scans and CAD/CAM 3D printing technology. Primary Outcome: Changes in occlusal thickness will be measured at specific reference points on the occlusal surface using an Iwanson caliper. Measurements will be taken at baseline and again after 3 months.(7. Rossi, G. D., Lisman, P., \& Leyte-Vidal, M. A. (2007)) Secondary Outcomes: Knowledge, attitudes, and practices (KAP) related to mouthguard use, assessed via a structured questionnaire (Vignesh et al., 2023). Cost-efficiency, evaluated using the incremental cost-effectiveness ratio (ICER). after one year. Changes in oral functions and speech, measured with a validated Likert-scale questionnaire (Mat Zainal et al., 2024), administered at baseline, 3 months, and 6 months. The trial aims to assess whether 3D-printed mouthguards offer equal or better protection against orofacial injuries compared to traditional mouthguards

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-08-01
• Primary completion: 2025-10-01
• Completion: 2026-08-01
• First posted: 2025-06-02
• Last updated: 2025-06-02

Locations

1 site across 1 country: Egypt