Back to resultsEdulcorants Effect in Caries Risk Schoolchildren (STEVIA)
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
delivery of snacks
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries
Eligibility Criteria
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.
Sites / Locations
- Pediatric dentistry dept
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Stevia snacks
Maltitol snacks
Sugared snacks
Arm Description
Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks.
Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks.
Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks.
Outcomes
Primary Outcome Measures
Caries risk reduction
calculation of the carie risk reduct using a standardised method aka "Cariogram"
reduction of salivary cariogenic bacteria
reduction of salivary cariogenic bacteria of one level eg from 1000000 to 10000 CFU/ml
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03724864
First Posted
October 25, 2018
Last Updated
October 28, 2018
Sponsor
Università degli Studi di Sassari
1. Study Identification
Unique Protocol Identification Number
NCT03724864
Brief Title
Edulcorants Effect in Caries Risk Schoolchildren
Acronym
STEVIA
Official Title
Effect of a Daily Dose of Snacks Containing Mannitol or Stevia Rebaudiana as Sweeteners in High Caries Risk Schoolchildren
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
May 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Sassari
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
271 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stevia snacks
Arm Type
Experimental
Arm Description
Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks.
Arm Title
Maltitol snacks
Arm Type
Active Comparator
Arm Description
Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks.
Arm Title
Sugared snacks
Arm Type
Placebo Comparator
Arm Description
Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks.
Intervention Type
Dietary Supplement
Intervention Name(s)
delivery of snacks
Intervention Description
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.
Primary Outcome Measure Information:
Title
Caries risk reduction
Description
calculation of the carie risk reduct using a standardised method aka "Cariogram"
Time Frame
42 days
Title
reduction of salivary cariogenic bacteria
Description
reduction of salivary cariogenic bacteria of one level eg from 1000000 to 10000 CFU/ml
Time Frame
42 days
Secondary Outcome Measure Information:
Title
modification of the plaque-pH
Description
reduction of the Area Under the Curve (AUC) at the critical level of pH of 6.2 and 5.7
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Pediatric dentistry dept
City
Sassari
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Edulcorants Effect in Caries Risk Schoolchildren
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