Clinical trial NCT06601608: Efficacy of Locally Delivered Rosemary Extract Gel in Management of Periodontitis
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Periodontitis (stage 3)
Periodontal Pocket
Keywords: Periodontitis
local delivery drug
microbiological analysis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 16
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: probing depth
timeFrame: change from baseline at 3 months
Secondary outcomes:
measure: clinical attachment level, plaque index and gingival index
timeFrame: change from baseline at 3 months
measure: microbiological analysis
timeFrame: The bacterial load in the GCF sample will be assessed at baseline, 1 week and 1 month post-operatively.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry - Ain Shams University
Study officials:
affiliation: Faculty of Dentistry - Ain Shams University
name: Nevine Hassan Kheir El Din, Professor
role: STUDY_DIRECTOR
References: