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This randomized controlled clinical study investigates the effectiveness of Spirulina gel and Spirulina nanoparticles gel in treating Stage II Grade B periodontitis. The research aims to compare the two formulations in terms of clinical, radiological, and biochemical outcomes, such as pocket depth reduction, alveolar bone density improvement, and inflammatory marker levels. The study seeks to provide insights into the potential of Spirulina-based therapies for enhancing periodontal health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (control group) | Placebo Comparator | Participants in this arm will receive oral hygiene instruction and full mouth SRP of all teeth plus placebo gel instillation in the pocket. |
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| Group II (experimental I) | Active Comparator | Participants in this arm will receive oral hygiene instruction and full mouth SRP of all teeth followed by insertion of the spirulina gel instillation in the deepest selected periodontal pocket after drying the area around it. |
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| Group III (experimental II) | Experimental | Participants in this arm will receive oral hygiene instruction and full mouth SRP of all teeth followed by insertion of the spirulina nanogel instillation in the deepest selected periodontal pocket after drying the area around it. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo gel | Other | A gel without active Spirulina components applied as a control intervention. |
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Probing Pocket Depth (PPD) | The mean reduction in probing pocket depth in millimeters (mm) at periodontal sites treated with Spirulina gel and Spirulina nanoparticles gel. | at baseline, 1 month , 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Bone Density Improvement | Changes in alveolar bone density measured using radiographic imaging techniques. | at baseline and after 6 months |
| Biochemical Marker Levels | Reduction in inflammatory markers specifically Superoxide dismutase enzyme levels in gingival crevicular fluid. |
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Inclusion criteria:
Patients with good systemic health.
Patients who can maintain good oral hygiene.
Attachment loss 3-4 mm and probing pocket depth ≤ 5mm. Exclusion criteria for this study include: ·
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| Name | Affiliation | Role |
|---|---|---|
| Enas Elgendy, Prof.Dr | Kafrelsheikh University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Doctor Mohamed Samir Periodontal and Implantology Clinic | El-Sheikh Zayed City | Cairo Governorate | 12573 | Egypt |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Participants are randomly assigned to one of three arms: Spirulina Gel, Spirulina Nanoparticles Gel, or control. The interventions are administered over a defined period with radiological and biochemical assessments conducted at baseline and post-treatment.
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| Spirulina Gel | Dietary Supplement | A conventional Spirulina gel formulation applied as a periodontal therapy. |
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| Spirulina Nanoparticles Gel | Dietary Supplement | A novel Spirulina nanoparticles gel formulation applied as a periodontal therapy. |
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| Measured at baseline, 1 month ,3 months, and 6 months |