Impact of 3D-Printed and Custom Mouthguards on Speech and Oral Functions in Children Practicing Contact Sports
NCT ID: NCT06972823
Last Updated: 2025-05-15
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-08-31
2026-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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3D printed custom-made mouthguards
This arm will include participants receiving 3D printed custom mouthguards.
3D printed custom-made mouthguards
Participants in the first group will receive 3D printed custom-made mouthguards
Traditional custom-made mouthguards
Participants in the second group will receive traditional custom-made mouthguards.
Traditional custom-made mouthguards
Participants in the active comparator arm will receive traditional custom-made mouthguards as an intervention
Interventions
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3D printed custom-made mouthguards
Participants in the first group will receive 3D printed custom-made mouthguards
Traditional custom-made mouthguards
Participants in the active comparator arm will receive traditional custom-made mouthguards as an intervention
Eligibility Criteria
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Inclusion Criteria
* Participants actively engaged in contact sports.
* Children who require mouthguards for protection.
* Cooperative children.
Exclusion Criteria
* 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.
8 Years
14 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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yasir mohammed hassan aljadani
Master's Candidate, Department of Pediatric Dentistry, Cairo University
Principal Investigators
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Gihan M Abuelniel, Doctoral Degree (Professor)
Role: STUDY_DIRECTOR
Cairo University
Passant Nagi, Master's Degree
Role: STUDY_DIRECTOR
Cairo University
Locations
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Faculy of Dentistry, Cairo University
Cairo, , Egypt
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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. 2024 Aug 21:S0022-3913(24)00505-5. doi: 10.1016/j.prosdent.2024.07.021. Online ahead of print.
Mordini L, Lee P, Lazaro R, Biagi R, Giannetti L. Sport and Dental Traumatology: Surgical Solutions and Prevention. Dent J (Basel). 2021 Mar 23;9(3):33. doi: 10.3390/dj9030033.
Mat Zainal MK, Liew AKC, Abdullah D, Soo E, Abdul Hamid B, Ramlee RAM. Changes in oral functions and speech when using custom-fitted mouthguards: An uncontrolled before-and-after study. Dent Traumatol. 2024 Aug;40(4):460-469. doi: 10.1111/edt.12939. Epub 2024 Mar 8.
Green JI. The Role of Mouthguards in Preventing and Reducing Sports-related Trauma. Prim Dent J. 2017 May 1;6(2):27-34. doi: 10.1308/205016817821281738.
Dias Goncalves VP, Fontes Vieira CM, Colorado Lopera HA. The production and materials of mouthguards: Conventional vs additive manufacturing - A systematic review. Heliyon. 2024 Jul 8;10(14):e34294. doi: 10.1016/j.heliyon.2024.e34294. eCollection 2024 Jul 30.
Dolic O, Obradovic M, Kojic Z, Knezevic N, Trtic N, Veselinovic V, Arapovic-Savic M, Umicevic-Davidovic M, Krcic V. Traumatic Dental Injuries in Children and Adolescents from a Major Dental Clinic in Bosnia and Herzegovina: A 5-Year Retrospective Study. Medicina (Kaunas). 2024 Nov 8;60(11):1843. doi: 10.3390/medicina60111843.
Del Rossi G, Lisman P, Signorile J. Fabricating a better mouthguard. Part II: the effect of color on adaptation and fit. Dent Traumatol. 2008 Apr;24(2):197-200. doi: 10.1111/j.1600-9657.2007.00570.x.
De Queiroz, T. S., da Cruz, B. S., Demachkia, A. M. M., Borges, A. L. S., Tribst, J. P. M., & Paes Junior, T. J. d. A. (2023). Ergonomic sports mouthguards: A narrative literature review and future perspectives. Applied Sciences, 13(20), 11353.
Borin-Moura, L., Azambuja-Carvalho, P., Daer-de-Faria, G., Barros-Gonçalves, L., Kirst-Post, L., & Braga-Xavier, C. (2018). A 10-year retrospective study of dental trauma in permanent dentition. Revista Española de Cirugía Oral y Maxilofacial, 40(2), 65-70.
Avgerinos S, Stamos A, Nanussi A, Engels-Deutsch M, Cantamessa S, Dartevelle JL, Unamuno E, Del Grosso F, Fritsch T, Crouzette T, Striegel M, Sanchez CC, Okshah A, Tzimpoulas N, Naka O, Kouveliotis G, Tzoutzas I, Zoidis P, Synodinos F, Loizos E, Tasopoulos T, Haughey J, Rahiotis C. Position Statement and Recommendations for Custom-Made Sport Mouthguards. Dent Traumatol. 2025 Jun;41(3):246-251. doi: 10.1111/edt.13019. Epub 2024 Nov 22.
Abbott PV, Tewari N, Mills SC, Stasiuk H, Roettger M, O'Connell AC, Levin L. The International Association of Dental Traumatology (IADT) and the Academy for Sports Dentistry (ASD) guidelines for prevention of traumatic dental injuries: Part 4: Faceshields for the prevention of dental and oral trauma. Dent Traumatol. 2024 Feb;40 Suppl 1:10-11. doi: 10.1111/edt.12926.
Other Identifiers
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Custom Mouthguards and Speech
Identifier Type: -
Identifier Source: org_study_id
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