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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Dental Caries

Intervention / Treatment
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* Dietary Supplement: Effect of Stevioside and Rebaudioside on plaque pH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: good general health, normal salivary secretion rate, normal buffer capacity Exclusion Criteria: systemic diseases, salivary secretion reduction, reduced buffer capacity

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stevioside extract<br>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<br>* 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.<br>|
| Experimental: Rebauside extract<br>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<br>* 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.<br>|
| Sham Comparator: Saccarosio<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental caries, Stevioside, Rebaudioside, plaque pH, Streptococcus mutans