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CompletedNCT01757990Updated Jan 15, 2013

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

A Phase 2 interventional study of Effect of Stevioside and Rebaudioside on plaque pH in Dental Caries, sponsored by Università degli Studi di Sassari. Completed. Open to participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-15.

Sponsored by Università degli Studi di Sassari · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dental Caries

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Keywords

  • dental caries
  • Stevioside
  • Rebaudioside
  • plaque pH
  • Streptococcus mutans
03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's enrollment of 20 is below the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Università degli Studi di Sassari is the lead sponsor of 27 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

systemic diseases, salivary secretion reduction, reduced buffer capacity

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
20 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • Dietary supplementEffect 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.

06

What researchers measure

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

    Time frame: 5, 10, 15, 30, 45, 60 minutes

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01757990
Lead sponsor
Università degli Studi di Sassari
Collaborators
University of Milan
Responsible party
Guglielmo Campus (Associate Professor of Community Dentistry, Università degli Studi di Sassari) — Principal investigator
First posted
Dec 31, 2012
Start date
Mar 2012
Primary completion
May 2012
Completion
Jun 2012
Last update
Jan 15, 2013

Study contacts

Laura Strohmenger, MD
study chair · WHO Collaborating Centre for Community Dentistry and Oral Epidemiology University of Milan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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