Impact of Guided Biofilm Therapy on Epithelial and Mesenchymal Biomarkers in Periodontitis Patients

Официальное название

Impact of Guided Biofilm Therapy on Gingival Crevicular Fluid Epithelial and Mesenchymal Biomarkers in Periodontitis Patients: A Randomized Controlled Clinical Trial

Обзор

The goal of this clinical trial is to investigate the clinical and biochemical effects of the guided biofilm therapy protocol as an alternative to the conventional non-surgical periodontal therapy in patients with periodontitis. The main question it aims to answer is: Does the guided biofilm therapy (GBT) protocol have an impact on gingival crevicular fluid (GCF) epithelial and mesenchymal biomarkers in patients with periodontitis? All patients will be instructed to brush their teeth twice daily and will be supplied with the same type of toothpaste and toothbrush, with suitable interdental aids. All patients will be instructed to attend again after 7 days. At baseline, full-mouth periodontal charting and radiographs will be obtained and after 1-hour, GCF samples will be collected from both test and control groups. Sites allocated to control group will undergo supragingival debridement by using ultrasonic device. After one week, the control group will receive RSD using area specific (Gracey) curettes (Medesy, Italy) according to the 24-hours protocol and will receive teeth polishing by using rubber polishing cups and tooth polishing paste, while the test group will receive a full GBT protocol which includes eight steps: (1) ASSESS, (2) DISCLOSE, (3) MOTIVATE, (4) AIRFLOW, (5) PERIOFLOW, (6) PIEZON PS\*, (7) CHECK, and (8) RECALL. After finishing the treatment session, the patients will be asked to attend for follow up, clinical evaluation of PI, BOP, PPD, and CAL, and GCF samples collection after 1 month and 3 months.

Вмешательства

• Процедура Root surface debridement
  Control group sites that will receive conventional NSPT will undergo supragingival debridement by using ultrasonic device at baseline. After one week, sites will receive root surface debridement (RSD) using area specific (Gracey) curettes (Medesy, Italy) according to the 24-hours protocol.
• Устройство Guided Biofilm Therapy
  Test group sites will receive guided biofilm therapy (GBT) protocol using the Airflow Prophylaxis Master device by EMS which includes EMS DISCLOSING AGENT making the biofilm visible, EMS AIRFLOW combined with PLUS erythritol powder for removing biofilm, discoloration, and early calculus, PERIOFLOW removing the biofilm in deep periodontal pockets gently and thoroughly, and finally PIEZON PS for removing the remaining calculus.

Первичные конечные точки

• Change in probing pocket depth (PPD) [Срок оценки: 3 months]

Вторичные конечные точки (4)

• Clinical attachment level (CAL) [Срок оценки: 3 months]
• Bleeding on probing (BOP) [Срок оценки: 3 months]
• Plaque index (PI) [Срок оценки: 3 months]
• Levels of gingival crevicular fluid (GCF) biomarkers [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Adult subjects (>18 years).
• Subjects are not currently under active periodontal therapy or joining other trial in the last 3 months.
• Patients must be diagnosed with generalized unstable periodontitis with bilateral, symmetrical distribution of PPD ≥ 4mm and positive BOP.

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Критерии исключения

• Patients not diagnosed with periodontitis.
• Patients consuming antibiotics.
• Regular users of nonsteroidal anti-inflammatory drugs (NSAIDs).
• Patients receiving periodontal treatment 3-months prior to the study.
• Pregnant or mothers in a breastfeeding period.
• Third molars and teeth with furcation involvement.
• Patients taking antioxidant supplements.
• Patients with heavy calculus that would prevent PerioPaper strips entrance to the periodontal pocket.
• Patient with pulmonary diseases and with a history of allergy to erythritol.
• Patients not willing to participate. -

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Ирак · 1 центр

• College of Dentistry, University of Baghdad — Baghdad

Идентификаторы

NCT: NCT07286916 · 1108625

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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