GingivitisNCT07499596
Effect of Morus Nigra Mouthwash on Gingivitis Treatment
A study testing Scaling and Root Planing and Morus Nigra Mouthwash in people with Gingivitis, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gingivitis
- What is being tested?
- Scaling and Root Planing and Morus Nigra Mouthwash
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2026to 15 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
- Diagnosis of generalized gingivitis (Gingival Index > 1).
- Presence of at least 20 natural teeth.
- Systemically healthy individuals.
- Ability to provide informed consent.
Who cannot join
- 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.).
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: 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.
Read the 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.
- Conditions
- Gingivitis
- Being tested
- Scaling and Root Planing, Morus Nigra Mouthwash
- Keywords
- Morus nigra, Mouthwash, Cytokines
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and Root PlaningProcedure or surgery
Mechanical removal of dental plaque and calculus from the tooth surfaces
Morus Nigra MouthwashDietary supplement
Morus nigra extract based mouthwash, used 2 times a day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients in this group receive scaling and root planing (SRP) only. Receives: 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 Receives: Procedure: Scaling and Root Planing; Dietary Supplement: Morus Nigra Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Gingival Index (GI)
Gingival inflammation will be assessed using the Loe and Silness Gingival Index. Higher scores indicate more severe inflammation.
Measured: Baseline, 1 month, and 3 months.
Secondary outcomes (2)
Cytokine levels in Gingival Crevicular Fluid (GCF)
Evaluation of TNF-alpha, IL-1beta, and IL-10 levels in GCF using ELISA method.
Measured: Baseline, 1 month, and 3 months
Subgingival Bacterial Load
Detection and quantification of total bacterial load and specific periodontopathogenic bacteria using Real-time PCR
Measured: Baseline, 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start15 Jan 2026
- Primary completion15 Feb 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Alperen Kırmızıgül, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499596
- Sponsor's protocol ID
- 2025/04
- Status last verified
- Nov 2026
- First submitted
- 24 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: All collected individual participant data after de-identification (clinical indices, cytokine levels, and microbiological data)
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
- 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
- ClinicalTrials.gov ID
- NCT07499596
- Acronym / sponsor ID
- 2025/04
- Conditions
- Gingivitis
- Keywords
- Morus nigra, Mouthwash, Cytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 30 Mar 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: Scaling and Root PlaningPatients in this group receive scaling and root planing (SRP) only. |
| Test Group | Experimental | Procedure: Scaling and Root Planing, Dietary Supplement: Morus Nigra MouthwashPatients in this group receive scaling and root planing (SRP) followed by the use of Morus nigra mouthwash twice daily for 14 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of generalized gingivitis (Gingival Index > 1).
- Presence of at least 20 natural teeth.
- Systemically healthy individuals.
- Ability to provide informed consent.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Scaling and Root PlaningMechanical removal of dental plaque and calculus from the tooth surfaces | Procedure or surgery | Control Group, Test Group |
| Morus Nigra MouthwashMorus nigra extract based mouthwash, used 2 times a day for 14 days | Dietary supplement | Test Group |
Primary outcome
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.
2 secondary outcomes
Cytokine levels in Gingival Crevicular Fluid (GCF)
Time frame: Baseline, 1 month, and 3 months
Subgingival Bacterial Load
Time frame: Baseline, 1 month, and 3 months
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. All collected individual participant data after de-identification (clinical indices, cytokine levels, and microbiological data)
Related trials for Gingivitis
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A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
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Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
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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 Scaling and Root Planing and Morus Nigra Mouthwash in people with Gingivitis, 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 4 inclusion and 6 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?
Changes in Gingival Index (GI) (time frame: Baseline, 1 month, and 3 months.). 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.