The Effect of Stevia Rebaudiana Extracts on Different Variables Related to Caries: an in Vitro and in Vivo Evaluation.

January 12, 2013 updated by: Guglielmo Campus, Università degli Studi di Sassari

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

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

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

good general health, normal salivary secretion rate, normal buffer capacity

Exclusion Criteria:

systemic diseases, salivary secretion reduction, reduced buffer capacity

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: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stevioside extract
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.
Dietary supplement: Effect of Stevioside and Rebaudioside on plaque pH
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.
Experimental: Rebauside extract
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.
Dietary supplement: Effect of Stevioside and Rebaudioside on plaque pH
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.
Sham Comparator: Saccarosio
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.
Dietary supplement: Effect of Stevioside and Rebaudioside on plaque pH
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5, 10, 15, 30, 45, 60 minutes

Collaborators and Investigators

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

Sponsor

Università degli Studi di Sassari

Collaborators

University of Milan

Investigators

  • Study Chair: Laura Strohmenger, MD, WHO Collaborating Centre for Community Dentistry and Oral Epidemiology University of Milan

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

March 1, 2012

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

December 22, 2012

First Submitted That Met QC Criteria

December 22, 2012

First Posted (Estimate)

December 31, 2012

Study Record Updates

Last Update Posted (Estimate)

January 15, 2013

Last Update Submitted That Met QC Criteria

January 12, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SS_2012_10

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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