Clinical trial NCT06972823: Impact of 3D-Printed and Custom Mouthguards on Speech and Oral Functions in Children Practicing Contact Sports
Official title: Assessing Changes in Oral Functions and Speech After Using 3D-Printed vs. Custom-made Mouth Guards in Children Practicing Contact Sports:
        A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mouthguard Use
Orofacial Injuries Prevention
3D Printed Mouthguard
Traditional Custom-made Mouthguard
Speech and Oral Functions
Keywords: 3D printed mouthguard
traditional custom-made mouthguard
speech
oral functiions
CAD/CAM
3D printer
Children
Pediatric Dentistry
Contact sports
speaking
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned in a 1:1 ratio to one of two groups: one group will receive traditional custom-made mouthguards, and the other will receive 3D-printed custom-made mouthguards. Each participant will remain in their assigned group throughout the study period, and outcomes will be assessed independently for each group.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes Speech and in Oral Functions
timeFrame: Six months
Secondary outcomes:
measure: Knowledge, attitude, and practice (KAP) of children toward mouthguards
timeFrame: initial visit (the first month)
measure: Cost Efficiency of both mouthguards
timeFrame: one year
measure: Occlusal thickness changes
timeFrame: Three months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculy of Dentistry, Cairo University
Study officials:
affiliation: Cairo University
name: Gihan M Abuelniel, Doctoral Degree (Professor)
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Passant Nagi, Master's Degree
role: STUDY_DIRECTOR
References:
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