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

NCT06703554 | Completed DMC

• 1 other identifier: Sage Extract
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Caries,Dental; Dental Caries; Dental Diseases

Keywords

High caries risk; Chlorohexidine; Real-time PCR

Outcome Measures

Primary Outcomes (8)

• real-time PCR

  S. Mutans, Gtf B, Gtf D

  1 week

• real-time PCR

  S. Mutans, Gtf B, Gtf D

  2 weeks

• real-time PCR

  S. Mutans, Gtf B, Gtf D

  3 weeks

• real-time PCR

  S. Mutans, Gtf B, Gtf D

  4 weeks

• Gene Expression

  S. Mutans, Gene Expression

  1 week

• Gene Expression

  S. Mutans, Gene Expression

  2 weeks

• Gene Expression

  S. Mutans, Gene Expression

  3 weeks

• Gene Expression

  S. Mutans, Gene Expression

  4 weeks

Study Arms (2)

Sage oil mouthwash

EXPERIMENTAL

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

Chlorohexidine Mouthwash

ACTIVE COMPARATOR

0.12% chlorhexidine gluconate in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, and sodium saccharin

Biological: Chlorohexidine Mouthwash

Interventions

Sage Oil Mouthwash OTHER

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

Also known as: Natural product

Sage oil mouthwash

Chlorohexidine Mouthwash BIOLOGICAL

0.12% chlorhexidine gluconate in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, and sodium saccharin

Also known as: CHX mouthwash

Chlorohexidine Mouthwash

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• medically free, high caries patient with DMFT

You may not qualify if:

• pregnant and smokers

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Caries; Stomatognathic Diseases

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: same bottles dark in color was used
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at Conservative Department

Model Details: Sage Extract Natural product

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 25, 2024
• Study Start: January 2, 2024
• Primary Completion: May 20, 2024
• Study Completion: June 25, 2024
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)