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NCT Number: NCT07499596

Effect of Morus Nigra Mouthwash on Gingivitis Treatment

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.

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University Faculty of Dentistry

Battalgazi, Malatya, 44300, Turkey (Türkiye)

Location status: Recruiting

Location contact

Omer Alperen Kırmızıgul

CONTACT

[email protected]

+905073951987

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Scaling and Root Planing

Procedure

Mechanical removal of dental plaque and calculus from the tooth surfaces

Morus Nigra Mouthwash

Dietary Supplement

Morus nigra extract based mouthwash, used 2 times a day for 14 days

Primary outcomes

  1. 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

  1. Cytokine levels in Gingival Crevicular Fluid (GCF)

    Time frame: Baseline, 1 month, and 3 months

    Evaluation of TNF-alpha, IL-1beta, and IL-10 levels in GCF using ELISA method.

  2. Subgingival Bacterial Load

    Time frame: Baseline, 1 month, and 3 months

    Detection and quantification of total bacterial load and specific periodontopathogenic bacteria using Real-time PCR

Study contacts

Contact information is provided by the study sponsor or research team.

Burak Koçak, Dds

CONTACT

[email protected]

+9005446609444

Omer Alperen Kırmızıgul, Assistant Professor

CONTACT

[email protected]

+905073951987

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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