Efficacy of Locally Delivered Rosemary Extract Gel in Management of Periodontitis

Phase 2

Not yet recruiting

• Conditions: Periodontitis (stage 3); Periodontal Pocket
• Interventions: Drug: Herbal therapy; Drug: Placebo Drug

• Registration Number: NCT06601608
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

Sixteen 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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-15
• Study First Submitted QC: 2024-09-15
• Last Update Submitted: 2024-09-15
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Study Start: 2024-10
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Both genders aged between 25-45 years.
2. Healthy adult patients as evidenced by Burket's oral medicine health history questionnaire.
3. Stage III grade B periodontitis with at least two non-adjacent sites in posterior teeth with PD ≥ 6 mm, CAL ≥ 5 mm showing BOP and ≤ 4 teeth lost due to periodontitis.
4. Patients ready to comply with oral hygiene measures.

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Exclusion Criteria

1. Smokers.
2. Pregnant or lactating females.
3. Drug abusers.
4. Patients taking antibiotics or performed any periodontal treatment in the previous 6 months.
5. Patients who have a known allergy or hypersensitivity to rosemary, its constituents, or other members of the Lamiaceae family.
6. Patients with parafunctional habits.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosemary extract gel	Herbal therapy	rosemary extract gel will be applied in deep periodontal pockets with a concentration 5%.
placebo gel	Placebo Drug	a placebo gel will be applied in deep periodontal pockets in stage III periodontitis patients as an adjunct to non-surgical periodontal therapy.

Primary Outcome Measures

Name	Time	Method
probing depth	change from baseline at 3 months	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.

Secondary Outcome Measures

Name	Time	Method
clinical attachment level, plaque index and gingival index	change from baseline at 3 months	- 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
microbiological analysis	The bacterial load in the GCF sample will be assessed at baseline, 1 week and 1 month post-operatively.	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.

Trial Locations

Locations (1)

Faculty of Dentistry - Ain Shams University; 🇪🇬 Cairo, Egypt