Comparison of the Efficacy of Chlorhexidine and Morus Nigra Mouthwashes in the Treatment of Periodontal Diseases
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Gingival Index (GI)
研究概览
简要总结
This study aims to evaluate and compare the clinical, biochemical, and microbiological effects of chlorhexidine and Morus nigra (blackberry) mouthwashes used as an adjunct to non-surgical periodontal treatment (scaling and root planing - SRP) in patients with periodontal diseases. The participants will be divided into three groups: a control group receiving only SRP, a group receiving SRP combined with chlorhexidine mouthwash, and a group receiving SRP combined with Morus nigra mouthwash. Clinical periodontal parameters, gingival crevicular fluid levels of inflammatory markers (including TNF-a, IL-1b, and IL-10), and subgingival plaque microbiological profiles (such as red complex bacteria and Fusobacterium) will be evaluated at baseline, 1 month, and 3 months after the treatment.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with periodontitis.
- •Systemically healthy individuals.
- •Patients aged between 18 and 65 years.
- •Presence of at least 20 natural teeth.
- •Volunteering to participate in the study and signing the informed consent form.
排除标准
- •Presence of any systemic disease that may affect periodontal health or systemic inflammatory response (e.g., Diabetes Mellitus, immunological disorders).
- •Current smokers or use of any tobacco products.
- •Pregnancy or lactation.
- •Use of systemic antibiotics, anti-inflammatory drugs, or immunosuppressive medications within the last 6 months.
- •Having received any non-surgical or surgical periodontal treatment within the last 6 months.
- •Known allergy or sensitivity to chlorhexidine or Morus nigra (blackberry) extracts.
- •Patients using orthodontic appliances.
研究组 & 干预措施
Control Group
Non-surgical periodontal treatment consisting of full-mouth scaling and root planing (SRP) using ultrasonic and hand instruments.
干预措施: Scaling and Root Planing (SRP) (Procedure)
Chlorhexidine Group
As an adjunct to scaling and root planing, patients will rinse with 15 ml of 0.12% chlorhexidine gluconate mouthwash twice a day (morning and evening) for 1 minute. The duration of the intervention is 14 days.
干预措施: 0.12% Chlorhexidine Gluconate Mouthwash (Drug)
Chlorhexidine Group
As an adjunct to scaling and root planing, patients will rinse with 15 ml of 0.12% chlorhexidine gluconate mouthwash twice a day (morning and evening) for 1 minute. The duration of the intervention is 14 days.
干预措施: Scaling and Root Planing (SRP) (Procedure)
Morus Nigra Group
As an adjunct to scaling and root planing, patients will rinse with 15 ml of a standardized mouthwash containing 5% Morus nigra extract twice a day (morning and evening) for 1 minute. The duration of the intervention is 14 days.
干预措施: 5% Morus Nigra Mouthwash (Drug)
Morus Nigra Group
As an adjunct to scaling and root planing, patients will rinse with 15 ml of a standardized mouthwash containing 5% Morus nigra extract twice a day (morning and evening) for 1 minute. The duration of the intervention is 14 days.
干预措施: Scaling and Root Planing (SRP) (Procedure)
结局指标
主要结局
Gingival Index (GI)
时间窗: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
Evaluation of gingival inflammation using a scale of 0 to 3.
Plaque Index (PI)
时间窗: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
Evaluation of plaque accumulation using a scale of 0 to 3.
Probing Depth (PD)
时间窗: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
Measurement of the distance from the gingival margin to the bottom of the periodontal pocket.
Clinical Attachment Level (CAL)
时间窗: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
Measurement of the distance from the cementoenamel junction to the bottom of the periodontal pocket.
Bleeding on Probing (BOP)
时间窗: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
Evaluation of the presence or absence of bleeding within 30 seconds after probing. The result is recorded as a percentage of sites that bleed.
次要结局
- Change in Gingival Crevicular Fluid (GCF) Inflammatory Markers(At baseline, 1 month, and 3 months after treatment)
- Change in Subgingival Plaque Microbiological Profile(At baseline, 1 month, and 3 months after treatment)
研究者
Burak Koçak
Research Assistant
Inonu University