Efficacy of Locally Delivered Rosemary Extract Gel in Management of Periodontitis

Ain Shams University

Status and phase: Not yet enrolling; Phase 2

Conditions: Periodontal Pocket; Periodontitis (stage 3)

Treatments: Drug: Placebo Drug; Drug: Herbal therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06601608

FDASU-Rec IM122331

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups, including a placebo group

Rosemary extract gel

Experimental group

Description:

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

Treatment:

Drug: Herbal therapy

placebo gel

Placebo Comparator group

Description:

a placebo gel will be applied in deep periodontal pockets in stage III periodontitis patients as an adjunct to non-surgical periodontal therapy.

Treatment:

Drug: Placebo Drug