Comparative Assessment of Thickness Changes in 3D-Printed vs. Custom-Made Mouth Guards for Children in Contact Sports
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 mouth guards, Traditional custom-made mouth guards.
- Кому может быть актуально
- Состояния в реестре: Mouthguard Use Orofacial Injuries Prevention 3D Printed Mouthguard Traditional Custom-made Mouthguard Occlusal Thickness Changes. 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 →
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Официальное название
Assessing Thickness Changes Following the Use of 3D-Printed Vs. Custom-Made Mouth Guards to Prevent Traumatic Dental Injuries in Children Practicing Contact Sports: A Randomized Clinical Trial.
Обзор
This study aims to compare changes in the thickness of traditional and 3D-printed custom mouth guards in pediatric athletes who participate in contact sports. Specifically, it will assess the occlusal thickness changes between both types of mouth guards. The research will involve 56 children engaged in contact sports, and the evaluation will cover occlusal thickness, speech, oral functions, and cost-effectiveness over the course of one yea
Подробное описание
This randomized clinical trial will be conducted at Cairo International Stadium, involving healthy children aged 8 to 14 who actively participate in contact sports and require mouthguards for safety. Participants must be physically fit and cooperative. With parental consent, they will be randomly assigned in a 1:1 ratio to one of two groups:
Group 1: Receives traditional custom-made mouthguards made from alginate impressions.
Group 2: Receives 3D-printed custom-made mouthguards created using digital intraoral scans and CAD/CAM 3D printing technology.
Primary Outcome: Changes in occlusal thickness will be measured at specific reference points on the occlusal surface using an Iwanson caliper. Measurements will be taken at baseline and again after 3 months.(7. Rossi, G. D., Lisman, P., \& Leyte-Vidal, M. A. (2007))
Secondary Outcomes:
Knowledge, attitudes, and practices (KAP) related to mouthguard use, assessed via a structured questionnaire (Vignesh et al., 2023).
Cost-efficiency, evaluated using the incremental cost-effectiveness ratio (ICER).
after one year. Changes in oral functions and speech, measured with a validated Likert-scale questionnaire (Mat Zainal et al., 2024), administered at baseline, 3 months, and 6 months.
The trial aims to assess whether 3D-printed mouthguards offer equal or better protection against orofacial injuries compared to traditional mouthguards
Вмешательства
- Устройство 3D printed custom-made mouth guards
Participants in the first group will receive 3D printed custom-made mouth guards - Устройство Traditional custom-made mouth guards
Participants in the active comparator arm will receive traditional custom-made mouth guards as an intervention
Первичные конечные точки
- Occlusal thickness changes [Срок оценки: Three months]
Вторичные конечные точки (3)
- Cost Efficiency of both mouth guards [Срок оценки: One year]
- Changes Speech and in Oral Functions [Срок оценки: Six months]
- Knowledge, attitude, and practice (KAP) of children toward mouthguards [Срок оценки: Initial visit]
Критерии участия
Критерии включения
Athletic children who play contact sports Age ranges between 8-14 years. Compliance: participants must agree to use mouth guard consistently Parental consent Physically fit
Критерии исключения
Athletic children who play contact sports Age ranges between 8-14 years. Compliance: participants must agree to use mouth guard consistently Parental consent Physically fit
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
- Faculty of Dentistry, Cairo University — Cairo
Публикации
- Abbott PV, Tewari N, O'Connell AC, Mills SC, Stasiuk H, Roettger M, Levin L. The International Association of Dental Traumatology (IADT) and the Academy for Sports Dentistry (ASD) guidelines for prevention of traumatic dental injuries: Part 3: Mouthguards for the prevention of dental and oral trauma. Dent Traumatol. 2024 Feb;40 Suppl 1:7-9. doi: 10.1111/edt.12925. PMID 38363704
- 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. PMID 38459669
- 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
- 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
- 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 PMID 39578680
- 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
Идентификаторы
NCT: NCT07000435 · Thickness of Mouthguards