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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01757990
First Posted: December 31, 2012
Last Update Posted: January 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Milan
Information provided by (Responsible Party):
Guglielmo Campus, Università degli Studi di Sassari
  Purpose
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.

Condition Intervention Phase
Dental Caries Dietary Supplement: Effect of Stevioside and Rebaudioside on plaque pH Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Guglielmo Campus, Università degli Studi di Sassari:

Primary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: March 2012
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

systemic diseases, salivary secretion reduction, reduced buffer capacity

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757990


Sponsors and Collaborators
Università degli Studi di Sassari
University of Milan
Investigators
Study Chair: Laura Strohmenger, MD WHO Collaborating Centre for Community Dentistry and Oral Epidemiology University of Milan
  More Information

Responsible Party: Guglielmo Campus, Associate Professor of Community Dentistry, Università degli Studi di Sassari
ClinicalTrials.gov Identifier: NCT01757990     History of Changes
Other Study ID Numbers: SS_2012_10
First Submitted: December 22, 2012
First Posted: December 31, 2012
Last Update Posted: January 15, 2013
Last Verified: January 2013

Keywords provided by Guglielmo Campus, Università degli Studi di Sassari:
dental caries
Stevioside
Rebaudioside
plaque pH
Streptococcus mutans

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases