Back to resultsThe Effect of Stevia Rebaudiana Extracts on Different Variables Related to Caries: an in Vitro and in Vivo Evaluation.
Primary Purpose
Dental Caries
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Effect of Stevioside and Rebaudioside on plaque pH
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries focused on measuring dental caries, Stevioside, Rebaudioside, plaque pH, Streptococcus mutans
Eligibility Criteria
Inclusion Criteria:
good general health, normal salivary secretion rate, normal buffer capacity
Exclusion Criteria:
systemic diseases, salivary secretion reduction, reduced buffer capacity
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
Stevioside extract
Rebauside extract
Saccarosio
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Plaque-pH modification
Plaque pH was measured at baseline and 5, 10, 15, 30, 45 and 60 minutes after each mouth rinse
Secondary Outcome Measures
Full Information
NCT ID
NCT01757990
First Posted
December 22, 2012
Last Updated
January 12, 2013
Sponsor
Università degli Studi di Sassari
Collaborators
University of Milan
1. Study Identification
Unique Protocol Identification Number
NCT01757990
Brief Title
The Effect of Stevia Rebaudiana Extracts on Different Variables Related to Caries: an in Vitro and in Vivo Evaluation.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Sassari
Collaborators
University of Milan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 containing stevioside and rebaudioside on plaque-pH.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
dental caries, Stevioside, Rebaudioside, plaque pH, Streptococcus mutans
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stevioside extract
Arm Type
Experimental
Arm Description
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.
Arm Title
Rebauside extract
Arm Type
Experimental
Arm Description
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.
Arm Title
Saccarosio
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Effect of Stevioside and Rebaudioside on plaque pH
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plaque-pH modification
Description
Plaque pH was measured at baseline and 5, 10, 15, 30, 45 and 60 minutes after each mouth rinse
Time Frame
5, 10, 15, 30, 45, 60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
good general health, normal salivary secretion rate, normal buffer capacity
Exclusion Criteria:
systemic diseases, salivary secretion reduction, reduced buffer capacity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Strohmenger, MD
Organizational Affiliation
WHO Collaborating Centre for Community Dentistry and Oral Epidemiology University of Milan
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
The Effect of Stevia Rebaudiana Extracts on Different Variables Related to Caries: an in Vitro and in Vivo Evaluation.
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