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Идёт набор NCT06912451

Sport Mouthguards: Devices for Preventing Dental Injuries in Sports

Без фазы С лечением Oral Health Dental Trauma Oral Health Knowledge, Attitude and Practice Among Patients Mouth Protectors

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: Sport custom mouthguard.
Кому может быть актуально
Состояния в реестре: Oral Health, Dental Trauma, Oral Health Knowledge, Attitude and Practice Among Patients, Mouth Protectors. Базовые параметры: 7 лет — 30 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
Бразилия
Следующий шаг
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Официальное название

Sport Mouthguards: Devices for Preventing Dental and Alveolar Injuries in Sports - A Longitudinal Study

Обзор

Objective: To evaluate the impact of mouthguards (MG) on acceptability, incidence of soft tissue injuries, periodontal and salivary parameters, as well as on the perception of the body in sports practice (PeCoPes) and on the quality of life of athletes, and evaluate the consequences of use on the characteristics, state of conservation, and biological and physical properties of the MG itself. Methodology: This is a longitudinal study that will include children, adolescents, and adults aged 7 to 30 years who practice sports and require MGs. Sociodemographic data, medical history, dental history, dietary habits, and sports practice data will be collected. Participants will undergo a complete oral clinical examination. Data on knowledge of traumatic dental injuries (TDI) and MGs will also be collected. Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use, the following parameters will be evaluated: presence of mucosal injuries, visible plaque index, gingival bleeding index, salivary flow, salivary pH, buffering capacity, and salivary microorganism count. Acceptability will be evaluated before the MG is delivered, immediately after delivery, and at 1, 3, and 6 months after use. PeCoPes and quality of life will be assessed before, 1, 3, and 6 months after MG use. The MG will be evaluated for bacterial contamination, delamination, roughness, dimensional changes related to shape and thickness, color change, and conservation status. The data will be tabulated and analyzed using SPSS 21.0, and appropriate statistical tests (p\<0.05) will be performed according to the study objectives.

Вмешательства

  • Устройство Sport custom mouthguard
    This mouthguard will be made using two 3mm vinyl acetate ethylene sheets in a vacuum machine, following the recommendations for an appropriate mouthguard regarding trauma prevention and patient comfort. The patients will be monitored after 1, 3, and 6 months of using the mouthguard.

Первичные конечные точки

  • Acceptability [Срок оценки: Acceptability will be evaluated before the MG is delivered, immediately after delivery, and at 1, 3, and 6 months after use.]
  • Incidence of soft tissue injuries [Срок оценки: Before the MG is delivered, and at 1, 3, and 6 months after use]
  • Periodontal and salivary parameters [Срок оценки: Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use.]
Вторичные конечные точки (3)
  • The perception of the body in sports practice (PeCoPes) [Срок оценки: PeCoPes will be assessed before, 1, 3, and 6 months after MG use.]
  • The quality of life of athletes [Срок оценки: Quality of life will be assessed before, 1, 3, and 6 months after MG use.]
  • The consequences of use on the characteristics, state of conservation, and biological and physical properties of the MG itself. [Срок оценки: Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use.]

Критерии участия

Критерии включения

  • Children, adolescents, and adults aged 7 to 30 years, with no systemic health issues, of both genders;
  • Engaging in sports practice at least twice a week.

Критерии исключения

  • Presence of cavitated dental caries and/or periodontitis;
  • Angle Class III malocclusion with negative anterior overjet;
  • Presence of non-removable prostheses or any other accessory in the upper or lower arch that may interfere with the adaptation of the mouthguard;
  • Use of medications that may interfere with any salivary parameters;
  • Children, adolescents, and adults with neurological disorders or communication difficulties.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Бразилия · 1 центр
  • Universidade Federal do Rio de Janeiro — Rio de Janeiro

Идентификаторы

NCT: NCT06912451 · 75456123.9.0000.0268

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗