Caries,DentalNCT06703554
The Impact of Sage Extract on GTS B and D Gene Expression in S. Mutans
A study testing Sage Oil Mouthwash and Chlorohexidine Mouthwash in people with Caries,Dental and Dental Caries, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental, Dental Caries, Dental Diseases
- What is being tested?
- Sage Oil Mouthwash and Chlorohexidine Mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2024to 25 Jun 2024
- Phase
- Interventional
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- medically free, high caries patient with DMFT
Who cannot join
- pregnant and smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Caries,Dental, Dental Caries, Dental Diseases
- Being tested
- Sage Oil Mouthwash, Chlorohexidine Mouthwash
- Keywords
- High caries risk, Chlorohexidine, Real-time PCR
- Medical subject headings
- Dental Caries, Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sage Oil MouthwashOther
Also called Natural product
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
Chlorohexidine MouthwashBiological
Also called CHX mouthwash
0.12% chlorhexidine gluconate in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, and sodium saccharin
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Biological: Chlorohexidine Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
real-time PCR
- Mutans, Gtf B, Gtf D
Measured: 1 week
real-time PCR
- Mutans, Gtf B, Gtf D
Measured: 2 weeks
real-time PCR
- Mutans, Gtf B, Gtf D
Measured: 3 weeks
real-time PCR
- Mutans, Gtf B, Gtf D
Measured: 4 weeks
Gene Expression
- Mutans, Gene Expression
Measured: 1 week
Gene Expression
- Mutans, Gene Expression
Measured: 2 weeks
Gene Expression
- Mutans, Gene Expression
Measured: 3 weeks
Gene Expression
- Mutans, Gene Expression
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start2 Jan 2024
- Primary completion20 May 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sage Extract Natural product
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Ezz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703554
- Sponsor's protocol ID
- Sage Extract
- Status last verified
- May 2025
- First submitted
- 10 Nov 2024
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06703554
- Acronym / sponsor ID
- Sage Extract
- Conditions
- Caries,Dental, Dental Caries, Dental Diseases
- Keywords
- High caries risk, Chlorohexidine, Real-time PCR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 25 Nov 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Sage Extract Natural product
| Arm | Type | Receives |
|---|---|---|
| Sage oil mouthwash | Experimental | Other: Sage Oil MouthwashSage 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 |
| Chlorohexidine Mouthwash | Active comparator | Biological: Chlorohexidine Mouthwash0.12% chlorhexidine gluconate in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, and sodium saccharin |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- medically free, high caries patient with DMFT
Key exclusion criteria (1 listed)
- pregnant and smokers
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 |
|---|---|---|
| Sage Oil MouthwashAlso: Natural productSage 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 MouthwashAlso: CHX mouthwash0.12% chlorhexidine gluconate in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, and sodium saccharin | Biological | Chlorohexidine Mouthwash |
Primary outcome
real-time PCR
Time frame: 1 week
S. Mutans, Gtf B, Gtf D
real-time PCR
Time frame: 2 weeks
S. Mutans, Gtf B, Gtf D
real-time PCR
Time frame: 3 weeks
S. Mutans, Gtf B, Gtf D
real-time PCR
Time frame: 4 weeks
S. Mutans, Gtf B, Gtf D
Gene Expression
Time frame: 1 week
S. Mutans, Gene Expression
Gene Expression
Time frame: 2 weeks
S. Mutans, Gene Expression
Gene Expression
Time frame: 3 weeks
S. Mutans, Gene Expression
Gene Expression
Time frame: 4 weeks
S. Mutans, Gene Expression
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 7 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sage Oil Mouthwash and Chlorohexidine Mouthwash in people with Caries,Dental and Dental Caries, run by Cairo 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 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: finished, as of the sponsor's last update on 7 May 2025. 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. 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?
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?
real-time PCR (time frame: 1 week). The study lists 8 primary outcomes in all. 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 7 May 2025.