Меню
Набор скоро начнётся NCT06972823

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

Без фазы С лечением Mouthguard Use Orofacial Injuries Prevention 3D Printed Mouthguard Traditional Custom-made Mouthguard

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 3D printed custom-made mouthguards, Traditional custom-made mouthguards.
Кому может быть актуально
Состояния в реестре: Mouthguard Use, Orofacial Injuries Prevention, 3D Printed Mouthguard, Traditional Custom-made Mouthguard. Базовые параметры: 8 лет — 14 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство 3D printed custom-made mouthguards
    Participants in the first group will receive 3D printed custom-made mouthguards
  • Устройство Traditional custom-made mouthguards
    Participants in the active comparator arm will receive traditional custom-made mouthguards as an intervention

Первичные конечные точки

  • Changes Speech and in Oral Functions [Срок оценки: Six months]
Вторичные конечные точки (3)
  • Knowledge, attitude, and practice (KAP) of children toward mouthguards [Срок оценки: initial visit (the first month)]
  • Cost Efficiency of both mouthguards [Срок оценки: one year]
  • Occlusal thickness changes [Срок оценки: Three months]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

Египет · 1 центр
  • Faculy of Dentistry, Cairo University — Cairo

Публикации

  • 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

Идентификаторы

NCT: NCT06972823 · Custom Mouthguards and Speech

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗