Efficacy of Locally Delivered Rosemary Extract Gel in Management of Periodontitis

Efficacy of Locally Delivered Rosemary Extract Gel as an Adjunct to Non-Surgical Periodontal Therapy in Management of Periodontitis (A Randomized Controlled Clinical Trial With Microbiological Analysis)

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Pocket; Periodontitis (Stage 3)
• Intervention / Treatment: Drug: Herbal therapy; Drug: Placebo Drug

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Faculty of Dentistry - Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rosemary extract gel; rosemary extract gel will be applied in deep periodontal pockets with a concentration 5%.	Drug: Herbal therapy; 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.; Other Names: rosemary extract gel; local delivery drug; phytotherapy
Placebo Comparator: placebo gel; 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; a placebo gel will be applied in deep pockets (>5mm) in stage III periodontitis patients as an adjunct to non-surgical periodontal therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.; Plaque index:0 = No plaque in gingival area.= 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.= 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.= Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.; Gingival index:0 = Normal gingiva= Mild inflammation - slight edema. No bleeding on probing= Moderate inflammation -redness, edema and glazing. Bleeding on probing.= Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding	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.

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Nevine Hassan Kheir El Din, Professor, Faculty of Dentistry - Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2024
• Primary Completion (Actual): August 2, 2025
• Study Completion (Actual): October 11, 2025

Study Registration Dates

• First Submitted: September 15, 2024
• First Submitted That Met QC Criteria: September 15, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Periodontitis; microbiological analysis; local delivery drug
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis; Periodontal Pocket; Therapeutics; Complementary Therapies; Phytotherapy
• Other Study ID Numbers: FDASU-Rec IM122331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No