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

Cairo University (CU)

Status: Begins enrollment in 2 months

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

Treatments: Device: Traditional custom-made mouthguards; Device: 3D printed custom-made mouthguards

Study type: Interventional

Funder types: Other

Identifiers

NCT06972823

Custom Mouthguards and Speech

Details and patient eligibility

About

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.

Full description

This randomized clinical trial will be conducted at Cairo International Stadium, enrolling healthy children aged 8 to 14 who are actively engaged in contact sports and require mouthguards for protection. Eligible participants must be cooperative and have no history of speech or neurological disorders, orthodontic treatment, or dental anomalies that may affect mouthguard adaptation. After obtaining informed consent from parents, participants will be randomly allocated in a 1:1 ratio into two groups.

Group 1 will receive traditional custom-made mouthguards fabricated from alginate impression material. Group 2 will receive 3D-printed custom-made mouthguards created from digital intraoral scans using CAD/CAM and 3D printing technology. All fittings will be adjusted for comfort, retention, and occlusal balance by the principal investigator.

The primary outcomes include changes in oral functions and speech, assessed using a validated Likert-scale questionnaire adapted from Mat Zainal et al. (2024), administered at baseline, 3 months, and 6 months. Secondary outcomes include evaluating the knowledge, attitude, and practice (KAP) toward mouthguard use using a structured questionnaire (Vignesh et al., 2023), cost efficiency via the incremental cost-effectiveness ratio (ICER), and occlusal thickness changes using an Iwanson caliper. This trial aims to determine whether 3D-printed mouthguards provide superior or equivalent function, comfort, and cost-efficiency compared to traditional methods, potentially advancing the standards of pediatric sports dentistry.

Enrollment: 60 estimated patients

Sex: All

Ages: 8 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children aged 8-14 years of both ages.
• Participants actively engaged in contact sports.
• Children who require mouthguards for protection.
• Cooperative children.

Exclusion criteria

• Children with a history of speech or neurological disorders affecting oral function
• Parental refusal to participate.
• Children currently undergoing orthodontic treatment with fixed appliances.
• Presence of severe dental anomalies or extensive missing teeth that could interfere with mouthguard adaptation.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

3D printed custom-made mouthguards

Experimental group

Description:

This arm will include participants receiving 3D printed custom mouthguards.

Treatment:

Device: 3D printed custom-made mouthguards

Traditional custom-made mouthguards

Active Comparator group

Description:

Participants in the second group will receive traditional custom-made mouthguards.

Treatment:

Device: Traditional custom-made mouthguards