Efficacy of Locally Delivered Rosemary Extract Gel in Management of Periodontitis

NCT06601608 | Completed Phase 2 DMC

• 1 other identifier: FDASU-Rec IM122331
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis (Stage 3); Periodontal Pocket

Keywords

Periodontitis; local delivery drug; microbiological analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• clinical attachment level, plaque index and gingival index

  change from baseline at 3 months

• microbiological analysis

  The bacterial load in the GCF sample will be assessed at baseline, 1 week and 1 month post-operatively.

Study Arms (2)

Rosemary extract gel

EXPERIMENTAL

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

Drug: Herbal therapy

placebo gel

PLACEBO COMPARATOR

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

Interventions

Herbal therapy 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

Rosemary extract gel

Placebo Drug DRUG

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

placebo gel

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both genders aged between 25-45 years.
• Healthy adult patients as evidenced by Burket's oral medicine health history questionnaire.
• 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.
• Patients ready to comply with oral hygiene measures.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry - Ain Shams University

Cairo, 02, Egypt

Location

MeSH Terms

Conditions

Periodontitis; Periodontal Pocket

Interventions

Phytotherapy

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Nevine Hassan Kheir El Din, Professor

  Faculty of Dentistry - Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident dentist at department of oral medicine and periodontology

Study Record Dates

• First Submitted: September 15, 2024
• First Posted: September 19, 2024
• Study Start: October 20, 2024
• Primary Completion: August 2, 2025
• Study Completion: October 11, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

EG (1)