Идёт набор NCT06980675

Ozonized Olive Oil in the Treatment of Periodontal Pockets

Без фазы С лечением Periodontal Pocket

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: Activated Ozonized Olive Oil Gel, Placebo gel.
Кому может быть актуально: Состояния в реестре: Periodontal Pocket. Базовые параметры: от 18 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: Италия
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

Clinical and Microbiological Study on Local Application of an Ozonated Olive Oil Gel in the Periodontal Pockets: a Randomized Double-blind Trial.

Обзор

A randomized controlled clinical trial was conducted on 16 patients (8 males and 8 women) who were diagnosed chronic periodontitis. All the patients has been divided by randomization in two groups: control group treated with placebo gel and experimental group treated with gel based on ozonated EVO olive oil. Both group after the evaluation of inclusion and exclusion criteria during the first visit, were subjected to hygiene treatment of removal tartar deposit, considered as standard of therapy for periodontitis. After 15 days the hygiene treatment, patients were been randomized in two groups following the flow chart (t0) starting with: periodontal probing, microbiological samples and the first administration of gel. Next week (t1), has been collected the compliance and did the second administration of gel; the procedures will be the same also for another week (t2), until the last week (t3) when has been registered the second periodontal probing and did the second microbiological samples. Data were collected to software Microsoft Excel and all the data analysis were conducted on this software to highlight significant differences between both groups. As the primary outcome was continuous variable and assuming normal distribution bilateral parametric test T-student was performed. An alpha error of 5% was considered, Beta error was not calculated as this was a pilot study.

Вмешательства

Устройство Activated Ozonized Olive Oil Gel
It is a natural oil which has been ozonized to improve the antimicrobial activity against periodontopathogenic bacterias
Другое Placebo gel
Placebo gel with same texture, color, way of administration and taste of Activated Ozonized Olive Oil Gel

Первичные конечные точки

Difference of Probing Pocket Depth (PPD) [Срок оценки: One measure to assess inclusion, second mesure at randomization and third measure after 21 days]

Вторичные конечные точки (1)

Difference of Total microbial load [Срок оценки: One measure at randomization and second measure after 21 days]

Критерии участия

Критерии включения

Patients with stage II, III, or IV periodontitis according to the new 2017 World Workshop periodontal classification
Patients of either sex and older than 18 years of age
Probing Pocket Depth (PPD) greater than or equal to 4 mm at 3 sites
Patients who have signed consent to the study
Collaborating patients