PeriodontitisNCT07540624
Efficacy of Chlorhexidine and Morus Nigra Mouthwashes After Periodontal Treatment
A study testing 0.12% Chlorhexidine Gluconate Mouthwash, 5% Morus Nigra Mouthwash and Scaling and Root Planing (SRP) in people with Periodontitis and Periodontal Disease, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis, Periodontal Disease
- What is being tested?
- 0.12% Chlorhexidine Gluconate Mouthwash, 5% Morus Nigra Mouthwash and Scaling and Root Planing (SRP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 May 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University Faculty of Dentistry
Battalgazi, Malatya, 44300
About this study
Official title: 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.
- Conditions
- Periodontitis, Periodontal Disease
- Being tested
- 0.12% Chlorhexidine Gluconate Mouthwash, 5% Morus Nigra Mouthwash, Scaling and Root Planing (SRP)
- Keywords
- Chlorhexidine, Morus nigra, Mouthwash, Scaling and Root Planing
- Medical subject headings
- Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Scaling and Root Planing (SRP)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Non-surgical periodontal treatment consisting of full-mouth scaling and root planing (SRP) using ultrasonic and hand instruments. Receives: 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. Receives: Drug: 0.12% Chlorhexidine Gluconate Mouthwash; Procedure: 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. Receives: Drug: 5% Morus Nigra Mouthwash; Procedure: Scaling and Root Planing (SRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Index (GI)
Evaluation of gingival inflammation using a scale of 0 to 3.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
Secondary outcomes (2)
Change in Gingival Crevicular Fluid (GCF) Inflammatory Markers
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
Measured: At baseline, 1 month, and 3 months after treatment
Change in Subgingival Plaque Microbiological Profile
Evaluation of subgingival plaque samples to determine the levels of red complex bacteria and Fusobacterium nucleatum using PCR (Polymerase Chain Reaction) analysis
Measured: At baseline, 1 month, and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start8 May 2025
- Primary completion1 Jun 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Koçak, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540624
- Sponsor's protocol ID
- INONU-2025/04
- Status last verified
- Nov 2026
- First submitted
- 23 Mar 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in the published article will be shared
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Chlorhexidine and Morus Nigra Mouthwashes in the Treatment of Periodontal Diseases
- ClinicalTrials.gov ID
- NCT07540624
- Acronym / sponsor ID
- INONU-2025/04
- Conditions
- Periodontitis, Periodontal Disease
- Keywords
- Chlorhexidine, Morus nigra, Mouthwash, Scaling and Root Planing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: Scaling and Root Planing (SRP)Non-surgical periodontal treatment consisting of full-mouth scaling and root planing (SRP) using ultrasonic and hand instruments. |
| Chlorhexidine Group | Experimental | Drug: 0.12% Chlorhexidine Gluconate Mouthwash, Procedure: Scaling and Root Planing (SRP)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. |
| Morus Nigra Group | Experimental | Drug: 5% Morus Nigra Mouthwash, Procedure: Scaling and Root Planing (SRP)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.12% Chlorhexidine Gluconate MouthwashAs 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. | Drug | Chlorhexidine Group |
| 5% Morus Nigra MouthwashAs 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. | Drug | Morus Nigra Group |
| Scaling and Root Planing (SRP)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. | Procedure or surgery | Chlorhexidine Group, Control Group, Morus Nigra Group |
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
Change in Gingival Crevicular Fluid (GCF) Inflammatory Markers
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in the published article will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.12% Chlorhexidine Gluconate Mouthwash, 5% Morus Nigra Mouthwash and Scaling and Root Planing (SRP) in people with Periodontitis and Periodontal Disease, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival Index (GI) (time frame: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.