- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07562295
Periodontal Health Among Cigarette, Electronic Cigarettes, and Narghile Smokers
Evaluation of Periodontal Health Among Cigarette, Electronic Cigarettes, and Narghile Smokers Among a Sample of Alhawsh Private University Students
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
The emergence of e-cigarettes and the increasing popularity of hookah smoking, alongside traditional cigarette use, have created a complex health landscape, particularly regarding periodontal health. Despite growing global awareness of smoking-related dangers, particularly among young people due to marketing of "safer" alternatives, there is a lack of research directly comparing the effects of these three smoking methods on periodontal tissues.
While research extensively covers the impact of smoking on periodontal tissues, despite the individual studies on each type of smoking, no study has directly compared the effects of cigarettes, e-cigarettes, and hookah on periodontal health in the same population.
Aim: study and compare the different effects of traditional cigarettes, e-cigarettes, and narghile on periodontal health among a sample of students at Al-Hawash Private University.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
-
-
Homs Governorate
-
Homs, Homs Governorate, Сирия, 0000
- Al-Hawash Private University
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Cigarette smokers: Individuals who have smoked five or more cigarettes per day for at least one year.
- E-cigarette smokers: Individuals who have smoked e-cigarettes one or more times per day for at least one year.
- narghile smokers: Individuals who have used a hookah one or more times per day for at least one year.
Exclusion Criteria:
- Non-smokers
- Ages older than 25 years
- Dual smokers: Individuals who smoke two or more types of tobacco.
- Individuals with systemic diseases, such as diabetes, heart disease, liver problems, and kidney disease
- Individuals who reported using antibiotics, steroids, or NSAIDs within the past month
- Individuals who have received periodontal treatment at least six months ago
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
Cigarette Smokers
|
Неинтервенционное исследование
|
|
E-cigarette Smokers
|
Неинтервенционное исследование
|
|
Narghile Smokers
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Неинтервенционное исследование
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Plaque Index (PI)
Временное ограничение: At enrollment
|
Plaque Index (PI) The PI was evaluated according to the Silness and Löe (1964) system. This system assesses the plaque thickness at the tooth cervical margin (closest to the gum) and has four scores: 0: no plaque;
|
At enrollment
|
|
Gingival Index (GI)
Временное ограничение: At enrollment
|
The gingival status was evaluated using the method of Löe and Silness (1963). The GI score perfectly evaluates the marginal and inter proximal tissues separately on the basis of the following three criteria (Löe & Silness, 1963): 0: no inflammation, healthy gingiva;
|
At enrollment
|
|
Probing Pocket Depth (PPD)
Временное ограничение: At enrollment
|
PPD is the distance between the gingival margin and the apical depth of the periodontal probe tip penetration.
The depth of the sulci or pockets was probed using a Williams periodontal probe with markings 1, 2, 3, 5,7,8, 9, 10 mm.
The clinical measurements were based on the four sites (buccal, mesial, distal, and lingual) of all the teeth, except the third molars (Natto et al., 2005b).
|
At enrollment
|
|
Clinical Attachment Level (CAL)
Временное ограничение: At enrollment
|
Clinical attachment level (CAL) is measured from the cementoenamel junction to the bottom of the sulcus or pocket at the four sites.
The mean is then calculated for each patient.
|
At enrollment
|
|
Bleeding On Probing (BOP)
Временное ограничение: At enrollment
|
The bleeding on probing was assessed through gentle probing of the orifice of the gingival crevice .If bleeding occurs within 10 seconds, a positive finding was established and the number of positive sites was recorded and then expressed as the percentage of the number of sites examined.
|
At enrollment
|
|
Tooth Mobility (TM)
Временное ограничение: At enrollment
|
Tooth mobility, was performed by alternatively pressing on the tooth buccal and lingual surfaces using one finger and one metallic instrument Tooth mobility was recorded (Fleszar et al., 1980) as follows: 0: physiologic mobility, firm tooth;
|
At enrollment
|
|
Gingival Recession (GR)
Временное ограничение: At enrollment
|
Gingival recession is measured by measuring the distance from the cementoenamel junction to the free gingival margin at the midpoint of the buccal surface.
|
At enrollment
|
|
Furcation Involvement ( FI)
Временное ограничение: At enrollment
|
Furcation involvement, is investigated clinically with a probe and classified according to the Hamp's classification system: Class 0 = no horizontal loss of periodontal tissue support (apart from the original scoring scale). Class I ≤3mm horizontal loss of periodontal tissue support. Class II > 3 mm horizontal loss of periodontal tissue support, no through-and-through furcation Class III through-and-through furcation (required to see the tip of the probe at the contralateral furcation opening) and additionally |
At enrollment
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 15-6-2025
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .