A Phase 2 interventional study of Herbal therapy and Placebo Drug in Periodontitis (Stage 3) and Periodontal Pocket, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Ain Shams University · Phase 2, Interventional, and Treatment
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 48 is close to the median of 45 across 1,191 interventional studies indexed under Periodontitis.
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Exclusion Criteria:
rosemary extract gel will be applied in deep periodontal pockets with a concentration 5%.
Drug: Herbal therapy
a placebo gel will be applied in deep periodontal pockets in stage III periodontitis patients as an adjunct to non-surgical periodontal therapy.
Drug: Placebo 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.
Also known as: rosemary extract gel, local delivery drug, phytotherapy
a placebo gel will be applied in deep pockets (\>5mm) in stage III periodontitis patients as an adjunct to non-surgical periodontal therapy
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.
Time frame: change from baseline at 3 months
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. * Plaque index: 0 = No plaque in gingival area. 1. = A film of plaque adhering to the free gingival margin and adjacent area of tooth. The plaque may be recognized only by running a probe across the tooth surface. 2. = Moderate accumulation of soft deposit within the gingival pocket and on the gingival pocket and on the gingival margin and/or adjacent tooth surface that can be seen by naked eye. 3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface. * Gingival index: 0 = Normal gingiva 1. = Mild inflammation - slight edema. No bleeding on probing 2. = Moderate inflammation -redness, edema and glazing. Bleeding on probing. 3. = Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding
Time frame: 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.
Time frame: The bacterial load in the GCF sample will be assessed at baseline, 1 week and 1 month post-operatively.
Plan to share: Undecided
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Ain Shams University