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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06972823
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Study First Posted: 2025-05-15
• Last Update Posted: 2025-05-15
• Study Start: 2025-08
• Primary Completion: 2026-02
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes Speech and in Oral Functions	Six months	Oral functions, including speaking difficulty, lisping, nausea, bulkiness, and mouth dryness, will be assessed using a validated questionnaire adapted from the study by Mat Zainal et al. (2024). The questionnaire will be administered at three distinct intervals (baseline, 3 months, and six months)

Secondary Outcome Measures

Name	Time	Method
Occlusal thickness changes	Three months	This study will assess the wear patterns of both types of mouthguards in children participating in contact sports. The wear patterns will be measured by evaluating the thickness reduction of the mouthguards over time using an Iwanson caliper (measured in millimeters, mm). This method will provide quantitative data on the durability and wear resistance of each type of mouthguard, helping to determine which type maintains its protective properties longer under the stress of regular use (Tewari et al., 2024). The mouthguard thickness will be measured at two distinct timepoints (baseline and three months)
Knowledge, attitude, and practice (KAP) of children toward mouthguards	initial visit (the first month)	The study will evaluate the knowledge, attitudes, and practices (KAP) of children regarding the use of mouthguards in preventing orofacial injuries during contact sports. Specifically, the study assesses children's awareness of the risks of orofacial injuries, their understanding of mouthguards as a protective measure, and their current usage patterns. Based on a previous study by Vignesh et al. (2023), a structured and well-adapted questionnaire will be given to all participants in both groups at the initial visit.
Cost Efficiency of both mouthguards	one year	This study will also assess the cost efficiency of both types of custom-made mouthguards by calculating the cost per unit, using the U.S Dollar (USD) as the unit of measurement. The incremental cost effectiveness ratio will be calculated after one year.; The following equation will be used to measure the incremental cost-effectiveness ratio (Sadatsafavi et al., 2009): ICER=(Mouthguard A cost- Mouthguard B cost)/(outcome of mouthguard A-Outcome of mouthguard B)

Trial Locations

Locations (1)

Faculy of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt