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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Patients in this group receive scaling and root planing (SRP) only. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scaling and Root Planing | Procedure | Mechanical removal of dental plaque and calculus from the tooth surfaces |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cytokine levels in Gingival Crevicular Fluid (GCF) | Evaluation of TNF-alpha, IL-1beta, and IL-10 levels in GCF using ELISA method. | Baseline, 1 month, and 3 months |
| Subgingival Bacterial Load | Detection and quantification of total bacterial load and specific periodontopathogenic bacteria using Real-time PCR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omer Alperen Kırmızıgul, Assistant Professor | Contact | +905073951987 | alperen.kirmizigul@inonu.edu.tr | |
| Burak Koçak, Dds | Contact | +9005446609444 | kocakburak44@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inonu University Faculty of Dentistry | Recruiting | Battalgazi | Malatya | 44300 | Turkey (Türkiye) |
All collected individual participant data after de-identification (clinical indices, cytokine levels, and microbiological data)
Starting 6 months after publication and for up to 5 years
Data will be available to researchers who provide a methodologically sound proposal to achieve aims in the approved proposal
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
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| Morus Nigra Mouthwash | Dietary Supplement | Morus nigra extract based mouthwash, used 2 times a day for 14 days |
|
| Baseline, 1 month, and 3 months |
| D009057 |
| Stomatognathic Diseases |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |