The Impact of Sage Extract on GTS B and D Gene Expression in S. Mutans

May 5, 2025 updated by: Dina Ezz, Cairo University

The Impact of Natural Sage Extract on Glucosyltransferase B and D Gene Expression in Streptococcus Mutans: A Randomized Clinical Trial Using Real Time Polymerase Chain Reaction

Glucosyltransferases (Gtfs) play a crucial role in the pathogenesis of dental caries caused by Streptococcus mutans. Gtfs is recognized as an attractive target for effective therapeutic interventions aimed at inhibiting cariogenic biofilms.

Objective: This study evaluates the antibacterial effects of sage extract compared to chlorhexidine mouthwashes on the expression of Gtf genes in S. mutans from salivary samples of high caries risk patients over a one-month follow-up, utilizing real-time polymerase chain reaction.

Methodology: This clinical trial involves 42 participants with a high risk for caries, who are randomly divided into two groups of 21 subjects each.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Glucosyltransferases (Gtfs) are essential in the development of dental caries caused by Streptococcus mutans. They are currently recognized as promising targets for effective therapeutic strategies aimed at disrupting cariogenic biofilms.

Objective: This study investigates the antibacterial effects of sage extract in comparison to chlorhexidine mouthwashes on the expression of Gtf genes in S. mutans from the saliva of patients at high risk for caries, over a one-month follow-up period, using real-time polymerase chain reaction.

Methodology: This clinical trial includes 42 high caries risk participants, who are randomly assigned to two groups, each consisting of 21 subjects.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • medically free, high caries patient with DMFT

Exclusion Criteria:

  • pregnant and smokers

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sage oil mouthwash
Sage oil obtained from a local market of herbal products in Egypt. In order to identify chemical composition of sage essential oils and overall purity, Gas Chromatography/ Mass Spectrometry analysis (GC/MS) performed
Other: Sage Oil Mouthwash
Sage oil obtained from a local market of herbal products in Egypt. In order to identify chemical composition of sage essential oils and overall purity, Gas Chromatography/ Mass Spectrometry analysis (GC/MS) performed
Other Names:
  • Natural product
Active Comparator: Chlorohexidine Mouthwash
0.12% chlorhexidine gluconate in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, and sodium saccharin
Biological: Chlorohexidine Mouthwash
0.12% chlorhexidine gluconate in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, and sodium saccharin
Other Names:
  • CHX mouthwash

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
real-time PCR
Time Frame: 1 week
S. Mutans, Gtf B, Gtf D
1 week
real-time PCR
Time Frame: 2 weeks
S. Mutans, Gtf B, Gtf D
2 weeks
real-time PCR
Time Frame: 3 weeks
S. Mutans, Gtf B, Gtf D
3 weeks
real-time PCR
Time Frame: 4 weeks
S. Mutans, Gtf B, Gtf D
4 weeks
Gene Expression
Time Frame: 1 week
S. Mutans, Gene Expression
1 week
Gene Expression
Time Frame: 2 weeks
S. Mutans, Gene Expression
2 weeks
Gene Expression
Time Frame: 3 weeks
S. Mutans, Gene Expression
3 weeks
Gene Expression
Time Frame: 4 weeks
S. Mutans, Gene Expression
4 weeks

Collaborators and Investigators

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

Sponsor

Cairo University

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 (Actual)

January 2, 2024

Primary Completion (Actual)

May 20, 2024

Study Completion (Actual)

June 25, 2024

Study Registration Dates

First Submitted

November 10, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Actual)

November 25, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sage Extract

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

No

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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