NCT07499596

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Jan 2026Jul 2026

Study Start

First participant enrolled

January 15, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Expected
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

March 24, 2026

Last Update Submit

April 8, 2026

Conditions

Gingivitis

Keywords

Morus nigraMouthwashCytokines

Outcome Measures

Primary Outcomes (1)

  • Changes in Gingival Index (GI)

    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 Outcomes (2)

  • Cytokine levels in Gingival Crevicular Fluid (GCF)

    Baseline, 1 month, and 3 months

  • Subgingival Bacterial Load

    Baseline, 1 month, and 3 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Patients in this group receive scaling and root planing (SRP) only.

Procedure: Scaling and Root Planing

Test Group

EXPERIMENTAL

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 PlaningDietary Supplement: Morus Nigra Mouthwash

Interventions

Scaling and Root PlaningPROCEDURE

Mechanical removal of dental plaque and calculus from the tooth surfaces

Control GroupTest Group
Morus Nigra MouthwashDIETARY_SUPPLEMENT

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

Test Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of generalized gingivitis (Gingival Index \> 1).
  • Presence of at least 20 natural teeth.
  • Systemically healthy individuals.
  • Ability to provide informed consent.

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University Faculty of Dentistry

Battalgazi, Malatya, 44300, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Gingivitis

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Central Study Contacts

Omer Alperen Kırmızıgul, Assistant Professor

CONTACT

+905073951987alperen.kirmizigul@inonu.edu.tr

Burak Koçak, Dds

CONTACT

+9005446609444kocakburak44@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 24, 2026

First Posted

March 30, 2026

Study Start

January 15, 2026

Primary Completion

February 15, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Starting 6 months after publication and for up to 5 years
Access Criteria
Data will be available to researchers who provide a methodologically sound proposal to achieve aims in the approved proposal

Locations

TU(1)