NCT01757990CompletedPhase 2
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.
Università degli Studi di Sassari0 sites20 target enrollmentStarted: March 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Primary Endpoint
- Plaque-pH modification
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •good general health, normal salivary secretion rate, normal buffer capacity
Exclusion Criteria
- •systemic diseases, salivary secretion reduction, reduced buffer capacity
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Guglielmo Campus
Associate Professor of Community Dentistry
Università degli Studi di Sassari
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