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

NCT ID: NCT01757990

Last Updated: 2013-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-06-30

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.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Effect of Stevioside and Rebaudioside on plaque pH

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: EXPERIMENTAL

Effect of Stevioside and Rebaudioside on plaque pH

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: SHAM_COMPARATOR

Effect of Stevioside and Rebaudioside on plaque pH

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

systemic diseases, salivary secretion reduction, reduced buffer capacity

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Milan

OTHER

Sponsor Role: collaborator

Università degli Studi di Sassari

OTHER

Sponsor Role: lead

Responsible Party

Guglielmo Campus

Associate Professor of Community Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Strohmenger, MD

Role: STUDY_CHAIR

WHO Collaborating Centre for Community Dentistry and Oral Epidemiology University of Milan

Other Identifiers

SS_2012_10

Identifier Type: -

Identifier Source: org_study_id