Edulcorants Effect in Caries Risk Schoolchildren (STEVIA)

Effect of a Daily Dose of Snacks Containing Mannitol or Stevia Rebaudiana as Sweeteners in High Caries Risk Schoolchildren

This double-blind RCT aimed to evaluate the effect of sugar-free snacks on caries risk in 6-9 years-old schoolchildren. Considering a 20% difference among groups, the number of subjects needed per group was set in 87. Two-hundred-seventy-one children at risk for caries measured through Cariogram were selected and randomly assigned to three groups consuming twice a day snacks containing Stevia or Maltitol or sugar for 42 days. Parents filled out a standardized questionnaire regarding personal, medical and oral behavioural information. Bleeding on probing, plaque pH and cariogenic microflora were assessed at baseline (t0), after 21 (t1) and 42 days of snacks' use (t2) and 120 days after the end of use (t3). Cariogram was also repeated at t2.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Dietary supplement: delivery of snacks

• Study Type: Interventional
• Enrollment (Actual): 271
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Sassari, Italy
    • Pediatric dentistry dept

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• more than 1 initial carious lesion in the enamel (ICDAS 2-3),
• but no manifest lesion in the dentine,
• a salivary MS concentration ≥10^5 CFU/ml.

Exclusion Criteria:

• Subjects with a history of systemic diseases and antibiotic therapy within 30 days before baseline were excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stevia snacks; Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks.	Dietary supplement: delivery of snacks; Subjects were randomly assigned to three groups (blue, green and yellow), receiving a single type of snack for 42 days. Block randomization ensured similar proportions of participants in each group. All subjects received snack packets (six cookies each) on a weekly basis. Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks. Both participants and investigators were blinded to the treatment assignment.
Active Comparator: Maltitol snacks; Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks.	Dietary supplement: delivery of snacks; Subjects were randomly assigned to three groups (blue, green and yellow), receiving a single type of snack for 42 days. Block randomization ensured similar proportions of participants in each group. All subjects received snack packets (six cookies each) on a weekly basis. Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks. Both participants and investigators were blinded to the treatment assignment.
Placebo Comparator: Sugared snacks; Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks.	Dietary supplement: delivery of snacks; Subjects were randomly assigned to three groups (blue, green and yellow), receiving a single type of snack for 42 days. Block randomization ensured similar proportions of participants in each group. All subjects received snack packets (six cookies each) on a weekly basis. Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks. Both participants and investigators were blinded to the treatment assignment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caries risk reduction	calculation of the carie risk reduct using a standardised method aka "Cariogram"	42 days
reduction of salivary cariogenic bacteria	reduction of salivary cariogenic bacteria of one level eg from 1000000 to 10000 CFU/ml	42 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modification of the plaque-pH	reduction of the Area Under the Curve (AUC) at the critical level of pH of 6.2 and 5.7	42 days

Collaborators and Investigators

• Sponsor: Università degli Studi di Sassari

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): May 8, 2018

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: October 28, 2018
• First Posted (Actual): October 30, 2018

Study Record Updates

• Last Update Posted (Actual): October 30, 2018
• Last Update Submitted That Met QC Criteria: October 28, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 1138/L

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No