Periodontal PocketclinicalNCT06900517
The Efficacy of Salvia Officinalis Gel in the Treatment of Periodontitis CLINICAL TRIAL
A study testing Salvia officinalis Gel in people with Periodontal Pocket, run by University of Baghdad.
Trial summary
From each participant, two sites of periodontal pockets ( ≥ 5 mm ) were selected and randomly allocated to either the test site (treated with scaling and RSD with S. officinalis gel) or the control site (treated with scaling and RSD alone). Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Periodontal Pocket
- What is being tested?
- Salvia officinalis Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with periodontitis had at least 20 natural teeth, with probing pocket depth (PPD) ≥ 5 mm and attachment loss ≥ 4 mm
Who cannot join
- Exclusion criteria were pregnancy, lactation, smoking, and any systemic disease that might affect periodontal disease progression or require antibiotic usage. Likewise, patients who had received anti-inflammatory medications or antibiotics in the preceding three months were excluded.
About this study
Official title: The Efficacy of Salvia Officinalis Gel in the Treatment of Periodontitis by Monitoring Gingival Crevicular Fluid Volume and Interleukin 17 Concentration
From each participant, two sites of periodontal pockets ( ≥ 5 mm ) were selected and randomly allocated to either the test site (treated with scaling and RSD with S. officinalis gel) or the control site (treated with scaling and RSD alone).
Read the detailed description
Background: Phytotherapy relies on the use of extracts derived from plants in pharmaceutical form. Herbal products have been effective in reducing periodontal diseases, as stated by many studies. Gingival crevicular fluid volume and concentrations of certain cytokines are precise and objective parameters in evaluating periodontitis treatment.
Aim of the study: Assessment of local application of Salvia officinalis (S. officinalis) gel as an adjunctive to scaling and root surface debridement (RSD) in the management of periodontitis.
Methods: A randomized clinical trial of split-mouth design for twenty-three subjects with periodontitis was assessed in this study. From each participant, two sites of periodontal pockets ( ≥ 5 mm ) were selected and randomly allocated to either the test site (treated with scaling and RSD with S. officinalis gel) or the control site (treated with scaling and RSD alone). A highly sensitive enzyme-linked immunosorbent assay (ELISA) was used to determine the concentration of interleukin 17 (IL-17) in gingival crevicular fluid (GCF).
- Conditions
- Periodontal Pocket
- Being tested
- Salvia officinalis Gel
- Medical subject headings
- Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salvia officinalis GelDietary supplement
Also called Scaling and root planing
From each participant, two sites of periodontal pockets ( ≥ 5 mm ) were selected and randomly allocated to either the test site (treated with scaling and RSD with S. officinalis gel) or the control site (treated with scaling and RSD alone).
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | will be treated with scaling and root planing alone Receives: Dietary Supplement: Salvia officinalis Gel |
| Test | Experimental | Will be treated by scaling and root plaing with the addition of Salvia officinalis Gel locally Receives: Dietary Supplement: Salvia officinalis Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCF volume
assessment the volume of GCF
Measured: 1 month
Secondary outcomes (1)
IL-17
Assessment of IL-17
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal PocketStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- From each participant, two sites of periodontal pockets ( ≥ 5 mm ) were selected and randomly allocated to either the test site (treated with scaling and RSD with S. officinalis gel) or the control site (treated with scaling and RSD alone).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Alrihaymee, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900517
- Sponsor's protocol ID
- 1/3/2025
- Acronym
- clinical
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Salvia Officinalis Gel in the Treatment of Periodontitis by Monitoring Gingival Crevicular Fluid Volume and Interleukin 17 Concentration
- ClinicalTrials.gov ID
- NCT06900517
- Acronym / sponsor ID
- clinical / 1/3/2025
- Conditions
- Periodontal Pocket
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 28 Mar 2025 (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.
From each participant, two sites of periodontal pockets ( ≥ 5 mm ) were selected and randomly allocated to either the test site (treated with scaling and RSD with S. officinalis gel) or the control site (treated with scaling and RSD alone).
Detailed description
Background: Phytotherapy relies on the use of extracts derived from plants in pharmaceutical form. Herbal products have been effective in reducing periodontal diseases, as stated by many studies. Gingival crevicular fluid volume and concentrations of certain cytokines are precise and objective parameters in evaluating periodontitis treatment.
Aim of the study: Assessment of local application of Salvia officinalis (S. officinalis) gel as an adjunctive to scaling and root surface debridement (RSD) in the management of periodontitis.
Methods: A randomized clinical trial of split-mouth design for twenty-three subjects with periodontitis was assessed in this study. From each participant, two sites of periodontal pockets ( ≥ 5 mm ) were selected and randomly allocated to either the test site (treated with scaling and RSD with S. officinalis gel) or the control site (treated with scaling and RSD alone). A highly sensitive enzyme-linked immunosorbent assay (ELISA) was used to determine the concentration of interleukin 17 (IL-17) in gingival crevicular fluid (GCF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- From each participant, two sites of periodontal pockets ( ≥ 5 mm ) were selected and randomly allocated to either the test site (treated with scaling and RSD with S. officinalis gel) or the control site (treated with scaling and RSD alone).
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Dietary Supplement: Salvia officinalis Gelwill be treated with scaling and root planing alone |
| Test | Experimental | Dietary Supplement: Salvia officinalis GelWill be treated by scaling and root plaing with the addition of Salvia officinalis Gel locally |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients diagnosed with periodontitis had at least 20 natural teeth, with probing pocket depth (PPD) ≥ 5 mm and attachment loss ≥ 4 mm
Key exclusion criteria (1 listed)
- Exclusion criteria were pregnancy, lactation, smoking, and any systemic disease that might affect periodontal disease progression or require antibiotic usage. Likewise, patients who had received anti-inflammatory medications or antibiotics in the preceding three months were excluded.
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 |
|---|---|---|
| Salvia officinalis GelAlso: Scaling and root planingFrom each participant, two sites of periodontal pockets ( ≥ 5 mm ) were selected and randomly allocated to either the test site (treated with scaling and RSD with S. officinalis gel) or the control site (treated with scaling and RSD alone). | Dietary supplement | Control, Test |
Primary outcome
GCF volume
Time frame: 1 month
assessment the volume of GCF
1 secondary outcome
IL-17
Time frame: one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Salvia officinalis Gel in people with Periodontal Pocket, run by University of Baghdad.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
GCF volume (time frame: 1 month). 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 28 Mar 2025.