Periodontitis (Stage 3)Phase 2NCT06601608
Efficacy of Locally Delivered Rosemary Extract Gel in Management of Periodontitis
A Phase 2 study testing Herbal therapy in people with Periodontitis (Stage 3) and Periodontal Pocket, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Periodontitis (Stage 3), Periodontal Pocket
- What is being tested?
- Herbal therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2024to 11 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Periodontitis (Stage 3), Periodontal Pocket
- Being tested
- Herbal therapy, Placebo Drug
- Keywords
- Periodontitis, local delivery drug, microbiological analysis
- Medical subject headings
- Periodontitis, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal therapyDrug
Also called rosemary extract gel, local delivery drug, phytotherapy
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 DrugDrug
a placebo gel will be applied in deep pockets (\>5mm) in stage III periodontitis patients as an adjunct to non-surgical periodontal therapy
| Study group | Role | What they receive |
|---|---|---|
| Rosemary extract gel | Experimental | rosemary extract gel will be applied in deep periodontal pockets with a concentration 5%. Receives: 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. Receives: Drug: Placebo Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline at 3 months
Secondary outcomes (2)
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
Measured: 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.
Measured: The bacterial load in the GCF sample will be assessed at baseline, 1 week and 1 month post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Oct 2024
- Primary completion2 Aug 2025
- Study completion11 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis (Stage 3)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roba abdelhamid mohamed elhady, Ain Shams University
- Investigators
- Nevine Hassan Kheir El Din, Professor, Study director, Faculty of Dentistry - Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601608
- Sponsor's protocol ID
- FDASU-Rec IM122331
- Status last verified
- Apr 2026
- First submitted
- 15 Sep 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06601608
- Acronym / sponsor ID
- FDASU-Rec IM122331
- Conditions
- Periodontitis (Stage 3), Periodontal Pocket
- Keywords
- Periodontitis, local delivery drug, microbiological analysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 2 Aug 2025 (actual)
- Study completion
- 11 Oct 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosemary extract gel | Experimental | Drug: Herbal therapyrosemary extract gel will be applied in deep periodontal pockets with a concentration 5%. |
| placebo gel | Placebo comparator | Drug: Placebo Druga placebo gel will be applied in deep periodontal pockets in stage III periodontitis patients as an adjunct to non-surgical periodontal therapy. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal therapyAlso: rosemary extract gel, local delivery drug, phytotherapyrosemary 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. | Drug | Rosemary extract gel |
| Placebo Druga placebo gel will be applied in deep pockets (\>5mm) in stage III periodontitis patients as an adjunct to non-surgical periodontal therapy | Drug | placebo gel |
Primary outcome
probing depth
Time frame: change from baseline at 3 months
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.
2 secondary outcomes
clinical attachment level, plaque index and gingival index
Time frame: change from baseline at 3 months
microbiological analysis
Time frame: The bacterial load in the GCF sample will be assessed at baseline, 1 week and 1 month post-operatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nevine Hassan Kheir El Din, Professor study director
Faculty of Dentistry - Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Herbal therapy in people with Periodontitis (Stage 3) and Periodontal Pocket, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
probing depth (time frame: change from baseline at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.