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:
Collaborator:
University of Milan
Information provided by (Responsible Party):
Guglielmo Campus, Università degli Studi di Sassari
ClinicalTrials.gov Identifier:
NCT01757990
First received: December 22, 2012
Last updated: January 12, 2013
Last verified: January 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 Università degli Studi di Sassari:

Primary Outcome Measures:
  • Plaque-pH modification [ Time Frame: 5, 10, 15, 30, 45, 60 minutes ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 22, 2012
Last Updated: January 12, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on April 17, 2014