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Набор скоро начнётся NCT05031260

COMORAL® the Oral Irrigation Unit Clinical Trial

Без фазы С лечением Gingivitis Plaque

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: applying COMORAL®.
Кому может быть актуально
Состояния в реестре: Gingivitis, Plaque. Базовые параметры: 18 лет — 25 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
Список центров уточняется — проверьте первичный протокол.
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

Effect of COMORAL® the Oral Irrigation Unit in Preventing Gingivitis and Plaque Formation

Обзор

This is a clinical study to evaluate the safety and effectiveness of COMORAL®, the intraoral water-spraying cleaning device that is developed to remove plaque around teeth in the oral cavity. To do so, 42 healthy subjects, 21 control and 21 experimental, will be recruited. To establish the baseline, all subjects will receive dental hygiene service. After 2 weeks, patients will be randomly assigned to either control or intervention group (21 individuals each). Both groups will be asked to brush their teeth once a day but without dental floss, mouth rinse, and gum chewing, throughout the 4 weeks of study period. During the study period, the experimental group will receive COMORAL® treatment three times a day every day for 4 weeks except Saturday and Sunday. Subjects will get evaluated for the oral status(PI, BOP, GI, PD, GR, CAL) and the status of periopathogens on visit 1, visit 2 and visit 3.

Подробное описание

This is a randomized, open-labeled, single-centered clinical study to evaluate COMORAL® the intraoral water-spraying cleaning device that is developed to remove plaque around teeth in the oral cavity. The purpose of this clinical study is to evaluate the safety and effectiveness of COMORAL® the oral irrigation unit in preventing gingivitis and plaque formation in adult patients.

42 patients between 18 to 25 years old who have a periodontal probing depth of 3 mm or less will be recruited. To establish the baseline, all the patients will receive dental hygiene service.

After 2 weeks (Visit 1), patients will be randomly assigned to either control or intervention group (21 individuals each). They will be asked to do the following instruction; Control group (21 total) - The individuals in the control group will be asked to brush their teeth once a day at home throughout the 4 weeks of study period. They will be asked not to use the supplementary oral hygiene products including mouth rinse, dental floss and chewing gum.

Experimental/Intervention group (21 total) - The individuals in this group will be asked to brush their teeth once a day at home throughout the 4 weeks of study period. They will be asked not to use the supplementary oral hygiene products including mouth rinse, dental floss and chewing gum. Instead, they will be asked to come to the clinic to use COMORAL® three times a day, every day except Saturday and Sunday.

Subjects in both groups will be evaluated for clinical indices (PI, BOP, GI, PD, GR, CAL) and the status of periopathogens on visit 1(baseline, visit 2(after 2 weeks), and visit 3(after 4 weeks). To measure the status of periopathogens, 3ml of saliva will be collected from each subject.

Вмешательства

  • Устройство applying COMORAL®
    The individuals in the experimental group will be asked to come to the clinic to use COMORAL® three times a day, every day except Saturday and Sunday.

Первичные конечные точки

  • gingival index (GI) [Срок оценки: Baseline, 2 weeks, 4 weeks]
  • plaque index (PI) [Срок оценки: Baseline, 2 weeks, 4 weeks]
  • bleeding on probing (BOP) [Срок оценки: Baseline, 2 weeks, 4 weeks]
  • pocket depth (PD) [Срок оценки: Baseline, 2 weeks, 4 weeks]
  • gingival recession (GR) [Срок оценки: Baseline, 2 weeks, 4 weeks]
  • clinical attachment loss (CAL) [Срок оценки: Baseline, 2 weeks, 4 weeks]
Вторичные конечные точки (1)
  • Periopathogens (PP) [Срок оценки: Baseline, 2 weeks, 4 weeks]

Критерии участия

Критерии включения

  • Healthy adult patients (ASA 1-2) aged 18 to 25 with a probing depth of 3mm or less
  • Those with 3 or more natural teeth in each quartile
  • Those who can voluntarily sign the consent form

Критерии исключения

  • Existing dental caries
  • Existing periodontitis
  • Other oral diseases

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
Открытое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05031260 · 20-001256

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗