- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07607639
Evaluation of Gingival Crevicular Fluid Cytokine Profiles in Children and Young Adults With Gingivitis
Comparison of Gingival Crevicular Fluid Biomarkers Between Childhood Gingivitis and Adolescent Gingivitis
This prospective observational case-control study aims to compare gingival crevicular fluid (GCF) biomarker profiles between children and young adults diagnosed with gingivitis. A total of approximately 80 systemically healthy participants will be recruited and divided into two groups: children aged 8-12 years and young adults aged 15-24 years. Individuals aged 13-14 years will be excluded as they represent a transitional pubertal period characterized by significant hormonal fluctuations that may influence inflammatory responses and confound biomarker levels.
Clinical periodontal parameters including gingival index, plaque index, bleeding on probing, and probing depth will be recorded. In addition, GCF samples will be collected from a standardized tooth and analyzed for levels of IL-1β, TNF-α, IL-10, and MMP-8 using enzyme-linked immunosorbent assay (ELISA).
The primary objective of the study is to evaluate and compare inflammatory and anti-inflammatory cytokine profiles between the two age groups. The findings may contribute to understanding age-related differences in gingival inflammatory responses and the potential role of hormonal transition in periodontal disease expression during childhood and early adulthood.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Gingivitis is the most common reversible periodontal disease in children and young adults and is characterized by gingival inflammation without periodontal attachment loss. Gingival crevicular fluid (GCF) contains inflammatory mediators and biomarkers that reflect periodontal tissue response and disease activity.
This prospective observational case-control study aims to compare GCF biomarker profiles between children and young adults diagnosed with gingivitis. Approximately 80 systemically healthy participants will be recruited and divided into two groups: children aged 8-12 years and young adults aged 15-24 years. Individuals aged 13-14 years will be excluded due to pubertal hormonal variability that may affect inflammatory biomarker levels.
Clinical periodontal parameters including Gingival Index, Plaque Index, Bleeding on Probing, and Probing Depth will be recorded. GCF samples will be collected from tooth #31 using standardized paper strips and analyzed for IL-1β, TNF-α, IL-10, and MMP-8 levels using ELISA.
The findings may contribute to understanding age-related differences in gingival inflammatory responses and biomarker expression in gingivitis.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Aycan Dal Dönertaş
- Номер телефона: +903382252595
- Электронная почта: aycandal@outlook.com
Учебное резервное копирование контактов
- Имя: Selcen Özcan Bulut
- Электронная почта: selcen_ozcan@hotmail.com
Места учебы
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Niğde, Турция (Туркие), 51240
- Рекрутинг
- Niğde Ömer Halisdemir University Faculty of Dentistry
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Контакт:
- Merdan Doğan
- Номер телефона: 905422076565
- Электронная почта: merdan@ohu.edu.tr
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Individuals aged 8-12 years (child group) or 15-24 years (young adult group)
- Clinical diagnosis of gingivitis
- Presence of fully erupted tooth #31 with closed apex
- Systemically healthy individuals
- No history of periodontal treatment in the last 3 months
- No antibiotic or anti-inflammatory drug use in the last 3 months
- Good cooperation and willingness to participate
- Written informed consent from participants or legal guardians (for minors)
Exclusion Criteria:
- Age 13-14 years (transitional pubertal period)
- Presence of periodontitis or other periodontal diseases
- Systemic, genetic, or immunological diseases
- Acute oral infections or conditions requiring emergency treatment
- Orthodontic appliances in the sampling region
- Smokers
- Pregnant or lactating individuals
- Individuals with cognitive, psychological, or physical disabilities affecting cooperation
- Inadequate eruption or incomplete root development of tooth #31
- Refusal to participate or withdrawal of consent
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
Childhood gingivitis group
Systemically healthy children aged 8-12 years diagnosed with gingivitis who will undergo clinical periodontal examination and gingival crevicular fluid biomarker analysis.
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Gingival crevicular fluid (GCF) samples will be collected from a standardized tooth (#31) using sterile absorbent paper strips (Periopaper®). Samples will be obtained after isolation and drying of the sampling site to avoid saliva contamination. Each strip will be placed gently in the gingival sulcus until mild resistance is felt and maintained for 30 seconds. Collected samples will be immediately stored at -80°C until laboratory analysis. Levels of inflammatory and anti-inflammatory biomarkers including IL-1β, TNF-α, IL-10, and MMP-8 will be quantified using enzyme-linked immunosorbent assay (ELISA) kits according to manufacturer instructions. This procedure is non-invasive and performed for diagnostic and comparative biomarker analysis purposes only. |
|
Young adult gingivitis group
Systemically healthy young adults aged 15-24 years diagnosed with gingivitis who will undergo clinical periodontal examination and gingival crevicular fluid biomarker analysis.
|
Gingival crevicular fluid (GCF) samples will be collected from a standardized tooth (#31) using sterile absorbent paper strips (Periopaper®). Samples will be obtained after isolation and drying of the sampling site to avoid saliva contamination. Each strip will be placed gently in the gingival sulcus until mild resistance is felt and maintained for 30 seconds. Collected samples will be immediately stored at -80°C until laboratory analysis. Levels of inflammatory and anti-inflammatory biomarkers including IL-1β, TNF-α, IL-10, and MMP-8 will be quantified using enzyme-linked immunosorbent assay (ELISA) kits according to manufacturer instructions. This procedure is non-invasive and performed for diagnostic and comparative biomarker analysis purposes only. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Gingival crevicular fluid TNF-α levels
Временное ограничение: Baseline
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Baseline
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Gingival crevicular fluid IL-1β levels
Временное ограничение: Baseline
|
Baseline
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Gingival crevicular fluid IL-10 levels
Временное ограничение: Baseline
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Baseline
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Gingival crevicular fluid MMP-8 levels
Временное ограничение: Baseline
|
Baseline
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Gingival Index
Временное ограничение: Baseline
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Gingival inflammation will be assessed using the Löe and Silness Gingival Index. Each surface will be scored between 0 and 3: 0 = normal gingiva
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Baseline
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Plaque Index
Временное ограничение: Baseline
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Dental plaque accumulation will be evaluated using the Silness and Löe Plaque Index. Each surface will be scored between 0 and 3: 0 = no plaque
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Baseline
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Bleeding on Probing Scores Assessed by Periodontal Probing
Временное ограничение: Baseline
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Bleeding on probing will be evaluated using a periodontal probe after gentle probing of the gingival sulcus. Bleeding presence will be recorded dichotomously: 0 = absence of bleeding 1 = presence of bleeding Higher scores indicate greater gingival inflammation. |
Baseline
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Periodontal Probing Depth Measurements Assessed With Williams Periodontal Probe
Временное ограничение: Baseline
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Periodontal probing depth will be measured in millimeters using a Williams periodontal probe at six sites per tooth.
Higher values indicate deeper periodontal pockets and worse periodontal condition.
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Baseline
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Соавторы и исследователи
Спонсор
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- NigdeOHU-GingivitisDOS
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.
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