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Rosemary extract is known for its antibacterial, anti-inflammatory and anti-oxidant properties that make it a promising therapeutic aid as a local delivery drug in deep periodontal pockets in adjunct to non-surgical periodontal therapy in management of periodontitis. These properties are due to the high content of phenolic compounds such as carnosic acid, urolic acid, rosmarinic acid or chlorogenic acid. Rosemary extract was previously investigated and proved its effectiveness against periodontopathogens in-vitro. Thus, its selected for this study to be administered in a gel form to assess its efficacy in management of periodontitis.
Forty eight patients with deep periodontal pockets more than 5 mm will be randomly assigned into 2 equal groups. The test group will receive the rosemary extract gel in adjunct to non-surgical periodontal therapy, while the control group will receive placebo gel.
Clinical evaluation of the clinical parameters including probing depth, gingival index, plaque index and clinical attachment level will be recorded.
Microbiological analysis using PCR test will be performed using perio-papers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosemary extract gel | Experimental | rosemary extract gel will be applied in deep periodontal pockets with a concentration 5%. |
|
| placebo gel | Placebo Comparator | a placebo gel will be applied in deep periodontal pockets in stage III periodontitis patients as an adjunct to non-surgical periodontal therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herbal therapy | Drug | rosemary extract gel is used for the first time as a local drug delivery as an adjunct to non-surgical periodontal therapy in management of stage III periodontitis patients. |
| Measure | Description | Time Frame |
|---|---|---|
| probing depth | Will be measured from the gingival margin to the bottom of the periodontal pocket to the nearest mm. with use of UNC 15 periodontal probe. | change from baseline at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| clinical attachment level, plaque index and gingival index | - Clinical attachment level (CAL): Will be measured from the CEJ to the depth of the periodontal pocket in millimeters.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nevine Hassan Kheir El Din, Professor | Faculty of Dentistry - Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry - Ain Shams University | Cairo | 02 | Egypt |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010514 | Periodontal Pocket |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D008517 | Phytotherapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| Placebo Drug | Drug | a placebo gel will be applied in deep pockets (>5mm) in stage III periodontitis patients as an adjunct to non-surgical periodontal therapy |
|
| change from baseline at 3 months |
| microbiological analysis | Microbiological analysis to evaluate the antibacterial effect of rosemary extract gel on quantitative change of P.gingivalis and A.actinomycetemcomitans in the gingival crevicular fluid (GCF) using perio-papers. Analyzed samples will be done using real time PCR technique. | The bacterial load in the GCF sample will be assessed at baseline, 1 week and 1 month post-operatively. |