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

Cairo University (CU)

Status: Begins enrollment in 1 month

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

Treatments: Device: 3D printed custom-made mouth guards; Device: Traditional custom-made mouth guards

Study type: Interventional

Funder types: Other

Identifiers

NCT07000435

Thickness of Mouthguards

Details and patient eligibility

About

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

Full 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

Enrollment: 56 estimated patients

Sex: All

Ages: 8 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Athletic children who play contact sports Age ranges between 8-14 years. Compliance: participants must agree to use mouth guard consistently Parental consent Physically fit

Exclusion criteria

Athletic children who play contact sports Age ranges between 8-14 years. Compliance: participants must agree to use mouth guard consistently Parental consent Physically fit

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

3D printed custom-made mouth guards

Experimental group

Description:

This arm will include participants receiving 3D printed custom mouth guards

Treatment:

Device: 3D printed custom-made mouth guards

Traditional custom-made mouthguards

Active Comparator group

Description:

Participants in the second group will receive traditional custom-made mouth guards

Treatment:

Device: Traditional custom-made mouth guards