Dental CariesPhase 2NCT01757990
The Effect of Stevia Rebaudiana Extracts on Different Variables Related to Caries: an in Vitro and in Vivo Evaluation.
A Phase 2 study testing Effect of Stevioside and Rebaudioside on plaque pH in people with Dental Caries, run by Università degli Studi di Sassari.
Trial summary
The aim of the present investigation was to evaluate the effect of stevioside and rebaudioside on several variables related to caries development. Two approaches were performed: an in vitro evaluation of the growth of a culture of mutans streptococci and in vivo randomized study on the effect of a single rinse… Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Effect of Stevioside and Rebaudioside on plaque pH
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Jun 2012
- Phase
- Phase 2
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- good general health, normal salivary secretion rate, normal buffer capacity
Who cannot join
- systemic diseases, salivary secretion reduction, reduced buffer capacity
About this study
Official title: A Comparative Clinical Evaluation of the Effect of Stevia Rebaudiana Extracts and Sucrose on Dental Plaque pH (Stephan Curve Trend) Using a Microtouch Electrode in Healthy Volunteers. A Phase II Study.
The aim of the present investigation was to evaluate the effect of stevioside and rebaudioside on several variables related to caries development. Two approaches were performed: an in vitro evaluation of the growth of a culture of mutans streptococci and in vivo randomized study on the effect of a single rinse containing stevioside and rebaudioside on plaque-pH.
- Conditions
- Dental Caries
- Being tested
- Effect of Stevioside and Rebaudioside on plaque pH
- Keywords
- dental caries, Stevioside, Rebaudioside, plaque pH, Streptococcus mutans
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of Stevioside and Rebaudioside on plaque pHDietary supplement
After measuring baseline plaque pH, the subjects rinsed for 1 minute with the sucrose solution. Plaque pH was then measured at 5, 10, 15, 30, 45 and 60 min after the mouth rinse.
| Study group | Role | What they receive |
|---|---|---|
| Stevioside extract | Experimental | After measuring baseline plaque pH, the subjects rinsed for 1 minute with the solution containing Stevioside extract. Plaque pH was then measured at 5, 10, 15, 30, 45 and 60 min after the mouth rinse. Receives: Dietary Supplement: Effect of Stevioside and Rebaudioside on plaque pH |
| Rebauside extract | Experimental | After measuring baseline plaque pH, the subjects rinsed for 1 minute with the solution containing Rebaudioside extract. Plaque pH was then measured at 5, 10, 15, 30, 45 and 60 min after the mouth rinse. Receives: Dietary Supplement: Effect of Stevioside and Rebaudioside on plaque pH |
| Saccarosio | Sham comparator | After measuring baseline plaque pH, the subjects rinsed for 1 minute with the sucrose solution. Plaque pH was then measured at 5, 10, 15, 30, 45 and 60 min after the mouth rinse. Receives: Dietary Supplement: Effect of Stevioside and Rebaudioside on plaque pH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque-pH modification
Plaque pH was measured at baseline and 5, 10, 15, 30, 45 and 60 minutes after each mouth rinse
Measured: 5, 10, 15, 30, 45, 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Sassari
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan
- Responsible party
- Principal investigator, Guglielmo Campus, Università degli Studi di Sassari
- Investigators
- Laura Strohmenger, MD, Study chair, WHO Collaborating Centre for Community Dentistry and Oral Epidemiology University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757990
- Sponsor's protocol ID
- SS_2012_10
- Status last verified
- Jan 2013
- First submitted
- 22 Dec 2012
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Clinical Evaluation of the Effect of Stevia Rebaudiana Extracts and Sucrose on Dental Plaque pH (Stephan Curve Trend) Using a Microtouch Electrode in Healthy Volunteers. A Phase II Study.
- ClinicalTrials.gov ID
- NCT01757990
- Acronym / sponsor ID
- SS_2012_10
- Conditions
- Dental Caries
- Keywords
- dental caries, Stevioside, Rebaudioside, plaque pH, Streptococcus mutans
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Università degli Studi di SassariUniversity, hospital or other
- Collaborators
- University of Milan
- Study start
- Mar 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 31 Dec 2012 (estimated)
- 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.
The aim of the present investigation was to evaluate the effect of stevioside and rebaudioside on several variables related to caries development. Two approaches were performed: an in vitro evaluation of the growth of a culture of mutans streptococci and in vivo randomized study on the effect of a single rinse containing stevioside and rebaudioside on plaque-pH.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stevioside extract | Experimental | Dietary Supplement: Effect of Stevioside and Rebaudioside on plaque pHAfter measuring baseline plaque pH, the subjects rinsed for 1 minute with the solution containing Stevioside extract. Plaque pH was then measured at 5, 10, 15, 30, 45 and 60 min after the mouth rinse. |
| Rebauside extract | Experimental | Dietary Supplement: Effect of Stevioside and Rebaudioside on plaque pHAfter measuring baseline plaque pH, the subjects rinsed for 1 minute with the solution containing Rebaudioside extract. Plaque pH was then measured at 5, 10, 15, 30, 45 and 60 min after the mouth rinse. |
| Saccarosio | Sham comparator | Dietary Supplement: Effect of Stevioside and Rebaudioside on plaque pHAfter measuring baseline plaque pH, the subjects rinsed for 1 minute with the sucrose solution. Plaque pH was then measured at 5, 10, 15, 30, 45 and 60 min after the mouth rinse. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- good general health, normal salivary secretion rate, normal buffer capacity
Key exclusion criteria (1 listed)
- systemic diseases, salivary secretion reduction, reduced buffer capacity
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 |
|---|---|---|
| Effect of Stevioside and Rebaudioside on plaque pHAfter measuring baseline plaque pH, the subjects rinsed for 1 minute with the sucrose solution. Plaque pH was then measured at 5, 10, 15, 30, 45 and 60 min after the mouth rinse. | Dietary supplement | Rebauside extract, Saccarosio, Stevioside extract |
Primary outcome
Plaque-pH modification
Time frame: 5, 10, 15, 30, 45, 60 minutes
Plaque pH was measured at baseline and 5, 10, 15, 30, 45 and 60 minutes after each mouth rinse
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 15 Jan 2013.
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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.
Laura Strohmenger, MD study chair
WHO Collaborating Centre for Community Dentistry and Oral Epidemiology University of Milan
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Effect of Stevioside and Rebaudioside on plaque pH in people with Dental Caries, run by Università degli Studi di Sassari.
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 15 Jan 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Plaque-pH modification (time frame: 5, 10, 15, 30, 45, 60 minutes). 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 15 Jan 2013.