NCT07540624

Brief Summary

This study aims to evaluate and compare the clinical, biochemical, and microbiological effects of chlorhexidine and Morus nigra (blackberry) mouthwashes used as an adjunct to non-surgical periodontal treatment (scaling and root planing - SRP) in patients with periodontal diseases. The participants will be divided into three groups: a control group receiving only SRP, a group receiving SRP combined with chlorhexidine mouthwash, and a group receiving SRP combined with Morus nigra mouthwash. Clinical periodontal parameters, gingival crevicular fluid levels of inflammatory markers (including TNF-a, IL-1b, and IL-10), and subgingival plaque microbiological profiles (such as red complex bacteria and Fusobacterium) will be evaluated at baseline, 1 month, and 3 months after the treatment.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
May 2025Jul 2026

Study Start

First participant enrolled

May 8, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

March 23, 2026

Last Update Submit

April 14, 2026

Conditions

PeriodontitisPeriodontal Disease

Keywords

ChlorhexidineMorus nigraMouthwashScaling and Root Planing

Outcome Measures

Primary Outcomes (5)

  • Gingival Index (GI)

    Evaluation of gingival inflammation using a scale of 0 to 3.

    Baseline (Day 0), 1 month, and 3 months after periodontal treatment.

  • Plaque Index (PI)

    Evaluation of plaque accumulation using a scale of 0 to 3.

    Baseline (Day 0), 1 month, and 3 months after periodontal treatment.

  • Probing Depth (PD)

    Measurement of the distance from the gingival margin to the bottom of the periodontal pocket.

    Baseline (Day 0), 1 month, and 3 months after periodontal treatment.

  • Clinical Attachment Level (CAL)

    Measurement of the distance from the cementoenamel junction to the bottom of the periodontal pocket.

    Baseline (Day 0), 1 month, and 3 months after periodontal treatment.

  • Bleeding on Probing (BOP)

    Evaluation of the presence or absence of bleeding within 30 seconds after probing. The result is recorded as a percentage of sites that bleed.

    Baseline (Day 0), 1 month, and 3 months after periodontal treatment.

Secondary Outcomes (2)

  • Change in Gingival Crevicular Fluid (GCF) Inflammatory Markers

    At baseline, 1 month, and 3 months after treatment

  • Change in Subgingival Plaque Microbiological Profile

    At baseline, 1 month, and 3 months after treatment

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Non-surgical periodontal treatment consisting of full-mouth scaling and root planing (SRP) using ultrasonic and hand instruments.

Procedure: Scaling and Root Planing (SRP)

Chlorhexidine Group

EXPERIMENTAL

As an adjunct to scaling and root planing, patients will rinse with 15 ml of 0.12% chlorhexidine gluconate mouthwash twice a day (morning and evening) for 1 minute. The duration of the intervention is 14 days.

Drug: 0.12% Chlorhexidine Gluconate MouthwashProcedure: Scaling and Root Planing (SRP)

Morus Nigra Group

EXPERIMENTAL

As an adjunct to scaling and root planing, patients will rinse with 15 ml of a standardized mouthwash containing 5% Morus nigra extract twice a day (morning and evening) for 1 minute. The duration of the intervention is 14 days.

Drug: 5% Morus Nigra MouthwashProcedure: Scaling and Root Planing (SRP)

Interventions

0.12% Chlorhexidine Gluconate MouthwashDRUG

As an adjunct to SRP, patients were instructed to rinse with 15 ml of 0.12% chlorhexidine gluconate mouthwash twice daily (morning and evening) for 1 minute. The treatment duration was 14 days.

Chlorhexidine Group
5% Morus Nigra MouthwashDRUG

As an adjunct to SRP, patients were instructed to rinse with 15 ml of a standardized mouthwash containing 5% Morus nigra extract twice daily (morning and evening) for 1 minute. The treatment duration was 14 days.

Morus Nigra Group
Scaling and Root Planing (SRP)PROCEDURE

All patients in the study underwent non-surgical periodontal therapy consisting of full-mouth scaling and root planing (SRP) using both ultrasonic devices and hand instruments.

Chlorhexidine GroupControl GroupMorus Nigra Group

Eligibility Criteria

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

You may qualify if:

  • Patients diagnosed with periodontitis.
  • Systemically healthy individuals.
  • Patients aged between 18 and 65 years.
  • Presence of at least 20 natural teeth.
  • Volunteering to participate in the study and signing the informed consent form.

You may not qualify if:

  • Presence of any systemic disease that may affect periodontal health or systemic inflammatory response (e.g., Diabetes Mellitus, immunological disorders).
  • Current smokers or use of any tobacco products.
  • Pregnancy or lactation.
  • Use of systemic antibiotics, anti-inflammatory drugs, or immunosuppressive medications within the last 6 months.
  • Having received any non-surgical or surgical periodontal treatment within the last 6 months.
  • Known allergy or sensitivity to chlorhexidine or Morus nigra (blackberry) extracts.
  • Patients using orthodontic appliances.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University Faculty of Dentistry

Battalgazi, Malatya, 44300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PeriodontitisPeriodontal Diseases

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

March 23, 2026

First Posted

April 20, 2026

Study Start

May 8, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

De-identified individual participant data that underlie the results reported in the published article will be shared

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available beginning 6 months and ending 36 months following article publication.
Access Criteria
Data will be shared with researchers who provide a methodologically sound proposal. Requests for data sharing should be directed to the principal investigator via email

Locations

TU(1)