The Efficacy of Salvia Officinalis Gel in the Treatment of Periodontitis CLINICAL TRIAL (clinical)

March 21, 2025 updated by: Sarah Alrihaymee, University of Baghdad

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

23

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients diagnosed with periodontitis had at least 20 natural teeth, with probing pocket depth (PPD) ≥ 5 mm and attachment loss ≥ 4 mm

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
will be treated with scaling and root planing alone
Dietary supplement: Salvia officinalis Gel
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).
Other Names:
  • Scaling and root planing
Experimental: Test
Will be treated by scaling and root plaing with the addition of Salvia officinalis Gel locally
Dietary supplement: Salvia officinalis Gel
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).
Other Names:
  • Scaling and root planing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GCF volume
Time Frame: 1 month
assessment the volume of GCF
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-17
Time Frame: one month
Assessment of IL-17
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

March 21, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/3/2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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