The Effect of Vitamin D Supplementation on the Anti-inflammatory Response in Periodontal Diseases
The Effect of Vitamin D Levels and Supplementation on Anti-inflammatory Response in Periodontal Disease: a Randomized Controlled Clinical Trial
A review of the literature revealed that while there are studies investigating the relationship between vitamin D and periodontal disease, there are no studies investigating the anti-inflammatory effect of vitamin D on periodontal disease. Investigators hypothesized that the increased incidence of periodontal disease in individuals with vitamin D deficiency might be due not only to pro-inflammatory effects but also to impaired bone metabolism and a decrease in the anti- inflammatory mechanism. Investigators aimed to determine this by comparing serum and DOS levels of 1,25-dihydroxyvitamin D (1,25(OH)2D), 25-hydroxyvitamin D (25(OH)D3), Receptor activator nuclear kappa B ligand (RANKL), osteoprotegerin (OPG), Tumor Necrosis Factor Related Apoptosis induced Ligand (TRAIL), Developmental endothelial locus (Del)-1, Lipoxin, Resolvin, interleukin (IL)-10, and transforming growth factor-β (TGF-β).
The study will include 120 individuals who are systemically healthy based on clinical and radiographic examinations and diagnosed with Stage I-II periodontitis, Stage III-IV periodontitis, chronic gingivitis, and periodontally healthy. Periodontal clinical parameters (Probing pocket depth (PPD), Clinical attachment level (CAL), Bleeding on probing (BOP), Plaque index (PI), Gingival index (GI)) will be recorded three times: before treatment, and 6 and 12 weeks after treatment. Gingival crevicular fluid (GCF) and serum samples will be collected from participants at baseline and 12 weeks later for biochemical analysis.
Обзор исследования
Статус
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Hatice Yemenoglu
- Номер телефона: +905052977517
- Электронная почта: htcymnglu@hotmail.com
Места учебы
-
-
-
Rize, Турция (Туркие), 53020
- Рекрутинг
- Recep Tayyip Erdogan University
-
Контакт:
- Hatice Yemenoglu
- Номер телефона: +904642220000
- Электронная почта: htcymnglu@hotmail.com
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Study groups will be formed according to the 2017 Periodontal Disease Classification. Accordingly:
- Periodontally healthy; absence of bleeding on probing, erythema, edema, patient symptoms, attachment, and bone loss
- Gingivitis; patients with an average gingival index ≥0.5 according to Löe and Silness
- Stage I-II periodontitis; patients with CAL 1-2 or 3-4 mm and a maximum PPD ≤5 mm, showing radiographic horizontal bone loss up to the coronal third of the root (15%-33%), but without tooth loss due to periodontitis
- Stage III-IV periodontitis; Stage 3 and 4 patients with ≥15 teeth in their mouth, with CAL ≥5 and PPD ≥6 in at least 6 areas, and radiographic bone loss extending to the middle or apical third of the root.
Exclusion Criteria:
- Individuals who have undergone periodontal treatment in the last 6 months, have systemic diseases (such as diabetes, parathyroid and thyroid-related endocrine diseases) that may affect periodontal status, patients with chronic liver disease, hypoparathyroidism and renal failure, those who have been using medications that may affect periodontal response (aspirin, non-steroidal anti-inflammatory drugs or steroids) for a long time, those who are using additional vitamin D or calcium supplements in the pre-study phase, those who are pregnant or breastfeeding, and those with hypercalcemia and malabsorption syndrome will not be included in the study.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Диагностика
- Распределение: Рандомизированный
- Интервенционная модель: Факторное присвоение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Group 1: Stage I-II periodontitis group with vitamin D deficiency
|
Participants will receive non-surgical periodontal treatment
Participants with vitamin D deficiency will receive supplemental vitamin D as recommended by their doctor
Participants will receive oral hygiene education
|
|
Экспериментальный: Group 2: Stage I-II periodontitis group with vitamin D deficiency
|
Participants will receive non-surgical periodontal treatment
Participants will receive oral hygiene education
|
|
Экспериментальный: Group 3: Stage III-IV periodontitis with vitamin D deficiency
|
Participants will receive non-surgical periodontal treatment
Participants with vitamin D deficiency will receive supplemental vitamin D as recommended by their doctor
Participants will receive oral hygiene education
|
|
Экспериментальный: Group 4: Stage III-IV periodontitis with vitamin D deficiency
|
Participants will receive non-surgical periodontal treatment
Participants will receive oral hygiene education
|
|
Экспериментальный: Group 5: Chronic gingivitis with vitamin D deficiency
|
Participants will receive non-surgical periodontal treatment
Participants with vitamin D deficiency will receive supplemental vitamin D as recommended by their doctor
Participants will receive oral hygiene education
|
|
Экспериментальный: Group 6: Chronic gingivitis with vitamin D deficiency
|
Participants will receive non-surgical periodontal treatment
Participants will receive oral hygiene education
|
|
Экспериментальный: Group 7: Periodontally healthy group with sufficient vitamin D levels
|
Participants will receive oral hygiene education
|
|
Экспериментальный: Group 8: Periodontally healthy group with vitamin D deficiency
|
Participants will receive oral hygiene education
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Probing pocket depth (PPD)
Временное ограничение: These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
|
These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
|
|
Clinical attachment level (CAL)
Временное ограничение: These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
|
These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Collection of gingival crevicular fluid and serum samples
Временное ограничение: These parameters were to be recorded 2 times: before treatment and 12 weeks after treatment
|
These parameters were to be recorded 2 times: before treatment and 12 weeks after treatment
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- KAD-FR-42
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. .