Impact of 3D-Printed and Custom Mouthguards on Speech and Oral Functions in Children Practicing Contact Sports
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3D printed custom-made mouthguards, Traditional custom-made mouthguards.
- Who it may be relevant to
- Registry conditions: Mouthguard Use, Orofacial Injuries Prevention, 3D Printed Mouthguard, Traditional Custom-made Mouthguard. Basic parameters: 8 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device 3D printed custom-made mouthguards
Participants in the first group will receive 3D printed custom-made mouthguards - Device Traditional custom-made mouthguards
Participants in the active comparator arm will receive traditional custom-made mouthguards as an intervention
Primary outcome measures
- Changes Speech and in Oral Functions [Time frame: Six months]
Secondary outcome measures (3)
- Knowledge, attitude, and practice (KAP) of children toward mouthguards [Time frame: initial visit (the first month)]
- Cost Efficiency of both mouthguards [Time frame: one year]
- Occlusal thickness changes [Time frame: Three months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Faculy of Dentistry, Cairo University — Cairo
Publications
- Vignesh, T. S., Chinni, S. K., Anumula, L., Sannapureddy, S., Kumar, Y. P., & Rohith, V. V. S. (2023). Knowledge, Attitudes, and Practices of Mouth Guards in the Prevention of Orofacial Injuries in Sports Persons-A Cross-sectional Study. Journal of Interdisciplinary Dentistry, 13(2), 84-89.
- Tewari N, Kahler B, Srivastav S, Goel S. How far have we come? A historic scoping review of dental traumatology literature. Dent Traumatol. 2022 Oct;38(5):345-355. doi: 10.1111/edt.12760. Epub 2022 May 25. PMID 35612349
- Tanaka Y, Maeda Y, Yang TC, Ando T, Tauchi Y, Miyanaga H. Prevention of orofacial injury via the use of mouthguards among young male rugby players. Int J Sports Med. 2015 Mar;36(3):254-61. doi: 10.1055/s-0034-1390498. Epub 2014 Oct 20. PMID 25329428
- Sousa AM, Pinho AC, Messias A, Piedade AP. Present Status in Polymeric Mouthguards. A Future Area for Additive Manufacturing? Polymers (Basel). 2020 Jul 3;12(7):1490. doi: 10.3390/polym12071490. PMID 32635307
- Singh G, Garg S, Damle SG, Dhindsa A, Kaur A, Singla S. A study of sports related occurrence of traumatic orodental injuries and associated risk factors in high school students in north India. Asian J Sports Med. 2014 Sep;5(3):e22766. doi: 10.5812/asjsm.22766. Epub 2014 Aug 28. PMID 25520762
- Sadatsafavi M, Marra CA, Ayas NT, Stradling J, Fleetham J. Cost-effectiveness of oral appliances in the treatment of obstructive sleep apnoea-hypopnoea. Sleep Breath. 2009 Aug;13(3):241-52. doi: 10.1007/s11325-009-0248-4. Epub 2009 Feb 20. PMID 19229577
- Roberts HW. Sports mouthguard overview: Materials, fabrication techniques, existing standards, and future research needs. Dent Traumatol. 2023 Apr;39(2):101-108. doi: 10.1111/edt.12809. Epub 2022 Nov 27. PMID 36436198
- Ntovas P, Ladia O, Kois JC, Rahiotis C, Revilla-Leon M. Digital workflow for the fabrication of custom-fit additively manufactured sports mouthguards with balanced occlusion using an optical jaw tracking system: A dental technique. J Prosthet Dent. 2025 Nov;134(5):1536-1541. doi: 10.1016/j.prosdent.2024.07.021. Epub 2024 Aug 22. PMID 39174379
Identifiers
NCT: NCT06972823 · Custom Mouthguards and Speech