Efficacy of Locally Delivered Rosemary Extract Gel in Management of Periodontitis

NCT ID: NCT06601608

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-06-30

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.

Conditions

Periodontitis (stage 3); Periodontal Pocket

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rosemary extract gel

rosemary extract gel will be applied in deep periodontal pockets with a concentration 5%.

Group Type: EXPERIMENTAL

Herbal therapy

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Placebo Drug

Intervention Type: DRUG

a placebo gel will be applied in deep pockets (\>5mm) in stage III periodontitis patients as an adjunct to non-surgical periodontal therapy

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

rosemary extract gel; local delivery drug; phytotherapy

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Roba abdelhamid mohamed elhady

Resident dentist at department of oral medicine and periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nevine Hassan Kheir El Din, Professor

Role: STUDY_DIRECTOR

Faculty of Dentistry - Ain Shams University

Locations

Faculty of Dentistry - Ain Shams University

Cairo, , Egypt

Countries

Egypt

Central Contacts

Roba Abdelhamid Elhady, Resident dentist

Role: CONTACT

rabi.elhady.std@dent.asu.edu.eg

+20 1011479533

Hadeel Gamal Elmalahy, Lecturer

Role: CONTACT

dr.hadeel@dent.asu.edu.eg

Other Identifiers

FDASU-Rec IM122331

Identifier Type: -

Identifier Source: org_study_id