Effect of Morus Nigra Mouthwash on Gingivitis Treatment

April 8, 2026 updated by: Ömer Alperen Kırmızıgül, Inonu University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Patients in this group receive scaling and root planing (SRP) only.
Procedure: Scaling and Root Planing
Mechanical removal of dental plaque and calculus from the tooth surfaces
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 month, and 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 month, and 3 months
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
Baseline, 1 month, and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2026

Primary Completion (Actual)

February 15, 2026

Study Completion (Estimated)

July 15, 2026

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected individual participant data after de-identification (clinical indices, cytokine levels, and microbiological data)

IPD Sharing Time Frame

Starting 6 months after publication and for up to 5 years

IPD Sharing Access Criteria

Data will be available to researchers who provide a methodologically sound proposal to achieve aims in the approved proposal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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