- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07540624
Efficacy of Chlorhexidine and Morus Nigra Mouthwashes After Periodontal Treatment
April 14, 2026 updated by: Burak Koçak, Inonu University
Comparison of the Efficacy of Chlorhexidine and Morus Nigra Mouthwashes in the Treatment of Periodontal Diseases
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.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
48
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 Locations
-
-
Malatya
-
Battalgazi, Malatya, Turkey (Türkiye), 44300
- Inonu University Faculty of Dentistry
-
-
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:
- 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.
Exclusion Criteria:
- 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.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
Non-surgical periodontal treatment consisting of full-mouth scaling and root planing (SRP) using ultrasonic and hand instruments.
|
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.
|
|
Experimental: Chlorhexidine Group
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.
|
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.
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.
|
|
Experimental: Morus Nigra Group
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gingival Index (GI)
Time Frame: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
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)
Time Frame: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
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)
Time Frame: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
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)
Time Frame: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
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)
Time Frame: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Gingival Crevicular Fluid (GCF) Inflammatory Markers
Time Frame: At baseline, 1 month, and 3 months after treatment
|
Analysis of TNF-a, IL-1b, and IL-10 levels in the gingival crevicular fluid using ELISA (or specific biochemical assay) to evaluate the local inflammatory response
|
At baseline, 1 month, and 3 months after treatment
|
|
Change in Subgingival Plaque Microbiological Profile
Time Frame: At baseline, 1 month, and 3 months after treatment
|
Evaluation of subgingival plaque samples to determine the levels of red complex bacteria and Fusobacterium nucleatum using PCR (Polymerase Chain Reaction) analysis
|
At baseline, 1 month, and 3 months after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 8, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
July 1, 2026
Study Registration Dates
First Submitted
March 23, 2026
First Submitted That Met QC Criteria
April 14, 2026
First Posted (Actual)
April 20, 2026
Study Record Updates
Last Update Posted (Actual)
April 20, 2026
Last Update Submitted That Met QC Criteria
April 14, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INONU-2025/04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data that underlie the results reported in the published article will be shared
IPD Sharing Time Frame
Data will be available beginning 6 months and ending 36 months following article publication.
IPD Sharing 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
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.
Clinical Trials on Periodontitis
-
Mahsa UniversityRecruitingPeriodontitis | Periodontitis Chronic Generalized Moderate | Periodontitis (Stage 3) | Periodontitis, Adult | Periodontitis Chronic Generalized Severe | Periodontitis, Chronic | Periodontitis Stage II | Periodontitis Chronic Localized Slight | Periodontitis Stage IIIMalaysia
-
Shanghai Ninth People's Hospital Affiliated to...Not yet recruitingPeriodontitis Stage II | Periodontitis Stage III | Periodontitis Stage IV
-
Misr University for Science and TechnologyCompletedPeriodontitis | Periodontitis Stage I | Periodontitis Stage II | Periodontitis Stage IIIEgypt
-
Cairo UniversityRecruitingPeriodontitis | Periodontitis Stage II | Periodontitis Stage IIIEgypt
-
Ataturk UniversityCompletedPeriodontitis | Periodontitis Stage I | Periodontitis Stage IITurkey (Türkiye)
-
Al-Azhar UniversityNot yet recruitingStage IV Periodontitis | Advanced Periodontitis | Stage III PeriodontitisEgypt
-
Panineeya Mahavidyalaya Institute of Dental Sciences...Research Institute for Genetic and Human TherapyUnknownGeneralized Adult Periodontitis
-
Duygu DegirmenciogluNot yet recruitingApical PeriodontitisTurkey (Türkiye)
-
University of ZagrebActive, not recruitingApical PeriodontitisCroatia
-
Hilal Çuhadar BeşiroğluCompletedApical PeriodontitisTurkey (Türkiye)
Clinical Trials on Scaling and Root Planing (SRP)
-
University of PisaCompletedObesity | Periodontal DiseasesItaly
-
University of PisaCompletedHypertension | PeriodontitisItaly
-
Panineeya Mahavidyalaya Institute of Dental Sciences...CompletedInflammation | Periodontitis | Menopause | Plaque
-
Masonic Cancer Center, University of MinnesotaWithdrawnAML | Acute Myelogenous Leukemia
-
University of Nove de JulhoCompletedGingivitis | Orthodontic Appliance Complication | Photodynamic TherapyBrazil
-
Postgraduate Institute of Dental Sciences RohtakRecruitingPeriodontitis | BruxismIndia
-
Universidad Complutense de MadridSunstar, Inc.RecruitingDiabetes | PeriodontitisSpain
-
King Saud UniversityZiauddin UniversityUnknownChronic Periodontitis
-
Postgraduate Institute of Dental Sciences RohtakRecruiting
-
KLOX Technologies Inc.CompletedModerate to Severe Chronic PeriodontitisCanada