The Effect of Stevia Rebaudiana Extracts on Different Variables Related to Caries: an in Vitro and in Vivo Evaluation.
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.
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2012
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 22, 2012
CompletedFirst Posted
Study publicly available on registry
December 31, 2012
CompletedJanuary 15, 2013
January 1, 2013
2 months
December 22, 2012
January 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plaque-pH modification
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
Study Arms (3)
Stevioside extract
EXPERIMENTALAfter 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
EXPERIMENTALAfter 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 COMPARATORAfter 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.
Interventions
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 Criteria
You may qualify if:
- good general health, normal salivary secretion rate, normal buffer capacity
You may not qualify if:
- systemic diseases, salivary secretion reduction, reduced buffer capacity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Università degli Studi di Sassarilead
- University of Milancollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Laura Strohmenger, MD
WHO Collaborating Centre for Community Dentistry and Oral Epidemiology University of Milan
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Community Dentistry
Study Record Dates
First Submitted
December 22, 2012
First Posted
December 31, 2012
Study Start
March 1, 2012
Primary Completion
May 1, 2012
Study Completion
June 1, 2012
Last Updated
January 15, 2013
Record last verified: 2013-01