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
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Inonu University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Changes in Gingival Index (GI)
Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of generalized gingivitis (Gingival Index \> 1).
- •Presence of at least 20 natural teeth.
- •Systemically healthy individuals.
- •Ability to provide informed consent.
Exclusion Criteria
- •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.).
Arms & Interventions
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
Intervention: Scaling and Root Planing (Procedure)
Control Group
Patients in this group receive scaling and root planing (SRP) only.
Intervention: 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
Intervention: Morus Nigra Mouthwash (Dietary Supplement)
Outcomes
Primary Outcomes
Changes in Gingival Index (GI)
Time Frame: Baseline, 1 month, and 3 months.
Gingival inflammation will be assessed using the Loe and Silness Gingival Index. Higher scores indicate more severe inflammation.
Secondary Outcomes
- Cytokine levels in Gingival Crevicular Fluid (GCF)(Baseline, 1 month, and 3 months)
- Subgingival Bacterial Load(Baseline, 1 month, and 3 months)
Investigators
Ömer Alperen Kırmızıgül
Assistant Professor
Inonu University