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Recruiting NCT07499596

Effect of Morus Nigra Mouthwash on Gingivitis Treatment

No phase Interventional Gingivitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Scaling and Root Planing, Morus Nigra Mouthwash.
Who it may be relevant to
Registry conditions: Gingivitis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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.

Interventions

  • Procedure Scaling and Root Planing
    Mechanical removal of dental plaque and calculus from the tooth surfaces
  • Dietary supplement Morus Nigra Mouthwash
    Morus nigra extract based mouthwash, used 2 times a day for 14 days

Primary outcome measures

  • Changes in Gingival Index (GI) [Time frame: Baseline, 1 month, and 3 months.]
Secondary outcome measures (2)
  • Cytokine levels in Gingival Crevicular Fluid (GCF) [Time frame: Baseline, 1 month, and 3 months]
  • Subgingival Bacterial Load [Time frame: Baseline, 1 month, and 3 months]

Eligibility criteria

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.).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Inonu University Faculty of Dentistry — Battalgazi

Identifiers

NCT: NCT07499596 · 2025/04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗