Impact of Guided Biofilm Therapy on Gingival Crevicular Fluid Epithelial and Mesenchymal Biomarkers in Periodontitis Patients: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in probing pocket depth (PPD)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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. -
结局指标
主要结局
Change in probing pocket depth (PPD)
时间窗: 3 months
After treatment completion PPD ≤4mm with no BOP at 4mm pockets
次要结局
- Clinical attachment level (CAL)(3 months)
- Bleeding on probing (BOP)(3 months)
- Plaque index (PI)(3 months)
- Levels of gingival crevicular fluid (GCF) biomarkers(3 months)
研究者
Ibrahim Haider Sadeq
Dentist
University of Baghdad