Evaluation of the Efficacy of Morus Nigra Mouthwash as an Adjunct to Scaling and Root Planing in the Treatment of Gingivitis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in Gingival Index (GI)
研究概览
简要总结
The aim of this study is to evaluate the clinical, microbiological, and biochemical effects of Morus nigra (black mulberry) mouthwash when used as an adjunct to non-surgical periodontal treatment (scaling and root planing - SRP) in patients with generalized gingivitis. Participants will be randomly assigned to two groups: one receiving SRP only, and the other receiving SRP plus Morus nigra mouthwash twice daily for 14 days. Clinical parameters, cytokine levels in gingival crevicular fluid (TNF-alpha, IL-1beta, IL-10), and subgingival bacterial load will be assessed at baseline, 1 month, and 3 months.
详细描述
Gingivitis is a reversible inflammatory disease of the gingiva. While mechanical plaque control (SRP) is the gold standard for treatment, herbal adjuncts like Morus nigra are of interest due to their anti-inflammatory and antioxidant properties. This randomized, controlled clinical trial will include 30 patients diagnosed with generalized gingivitis. The test group will use Morus nigra mouthwash for 14 days following SRP. Clinical indices (Gingival Index, Plaque Index) will be recorded. Biochemical analysis of cytokines (TNF-alpha, IL-1beta, IL-10) will be performed using ELISA, and microbiological analysis of subgingival plaque will be conducted using Real-time PCR.
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
- Double (Participant, 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
- •Diagnosis of generalized gingivitis (Gingival Index > 1).
- •Presence of at least 20 natural teeth.
- •Systemically healthy individuals.
- •Ability to provide informed consent.
排除标准
- •Smoking or use of tobacco products.
- •Presence of periodontitis (no clinical attachment loss).
- •Use of antibiotics or anti-inflammatory drugs in the last 6 months.
- •Pregnancy or lactation.
- •History of allergy to Morus nigra or mouthwash components.
- •Systemic diseases (Diabetes, cardiovascular diseases, etc.).
研究组 & 干预措施
Test Group
Patients in this group receive scaling and root planing (SRP) followed by the use of Morus nigra mouthwash twice daily for 14 days
干预措施: Scaling and Root Planing (Procedure)
Control Group
Patients in this group receive scaling and root planing (SRP) only.
干预措施: Scaling and Root Planing (Procedure)
Test Group
Patients in this group receive scaling and root planing (SRP) followed by the use of Morus nigra mouthwash twice daily for 14 days
干预措施: Morus Nigra Mouthwash (Dietary Supplement)
结局指标
主要结局
Changes in Gingival Index (GI)
时间窗: Baseline, 1 month, and 3 months.
Gingival inflammation will be assessed using the Loe and Silness Gingival Index. Higher scores indicate more severe inflammation.
次要结局
- Cytokine levels in Gingival Crevicular Fluid (GCF)(Baseline, 1 month, and 3 months)
- Subgingival Bacterial Load(Baseline, 1 month, and 3 months)
研究者
Ömer Alperen Kırmızıgül
Assistant Professor
Inonu University