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Набор скоро начнётся NCT06997770

Association Between Grade(B/C)of Stage III and IV Periodontitis and High Sensitivity C Reactive Protein Level in Serum and Oral Rinse Sample

— Наблюдательное hsCRP

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: hsCRP. Базовые параметры: 18 лет — 50 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
Индия
Следующий шаг
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Официальное название

Association Between Grade (B/C)of Stage III and Stage IV Periodontitis and High Sensitivity C Reactive Protein Levels in Serum and Oral Rinse Sample :A Cross Sectional Study

Обзор

According to 2017 World Workshop of Periodontology , the level of high sensitivity C reactive protein has been assumed to increase according to the grade of periodontitis, however, specific evidence regarding this is lacking at present. Hence, measuring high sensitivity C reactive protein in serum and oral rinse samples in systemically healthy individuals with periodontitis could be potentially useful in gaining insight on the systemic burden of periodontal disease.

Подробное описание

According to 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions , the level of high sensitivity c reactive protein has been assumed to increase according to the grade of periodontitis, however, specific evidence regarding this is lacking at present. Moreover, no information is currently available regarding the feasibility of detecting high sensitivity in oral rinse samples, which are relatively easy to collect and store, as compared to more commonly investigated oral fluids like saliva and gingival crevicular fluid Previous literature reports that saliva and gingival crevicular fluid levels of high sensitivity C reactive protein correlate with serum high sensitivity C reactive protein levels, therefore, there is a possibility that high sensitivity C reactive protein in oral rinse samples might also be correlated with serum high sensitivity C reactive protein levels. Measuring high sensitivity C reactive protein in serum and oral rinse samples in systemically healthy individuals with periodontitis could be potentially useful in providing easily accessible information about the systemic burden of periodontal inflammation as well as regarding detection of subclinical systemic inflammation.

Первичные конечные точки

  • Evaluation of hscrp level in oral rinse samples and serum in 3 groups of systemically healthy individuals [Срок оценки: 12-14 months]
Вторичные конечные точки (2)
  • Correlation of Probing pocket depth (PPD)and Clinical attachment level (CAL) with level of hsCRP in oral rinse and serum samples. [Срок оценки: 12-14 months]
  • Correlation of Bleeding on probing (BOP%) [Срок оценки: 12-14 months]

Критерии участия

Критерии включения

  • Patients in the age group of (18-50 years)
  • Presence of ≥ 20 natural teeth
  • Ability and willingness to give written informed consent
  • Patients belonging to 3 groups -periodontally healthy, stage III and stage IV grade B periodontitis, and stage III and stage IV grade C periodontitis .

Критерии исключения

  • • Patients with chronic inflammatory disease such as nephrotic syndrome, chronic renal failure, significant cardiovascular disease, established type 1 or type 2 diabetes mellitus, or active cancer within the past 5 years
  • Smokers and alcoholics
  • Pregnant females
  • Presence of xerostomia
  • Patients undergoing radiotherapy
  • Having received professional periodontal treatment within the previous 6 months
  • Having received antibiotic medication 3 months prior to study
  • Periapical pathology or other oral inflammatory conditions
  • Cognitive disability (interfering with ability to give sample)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Индия · 1 центр
  • PGIDS — Rohtak

Идентификаторы

NCT: NCT06997770 · Neha Sahjlan PeriodonticsPGIDS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗