Effect of a Daily Dose of Snacks Containing Mannitol or Stevia Rebaudiana as Sweeteners in High Caries Risk Schoolchildren
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 271
- Locations
- 1
- Primary Endpoint
- Caries risk reduction
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Stevia snacks
Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks.
Intervention: delivery of snacks (Dietary Supplement)
Maltitol snacks
Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks.
Intervention: delivery of snacks (Dietary Supplement)
Sugared snacks
Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks.
Intervention: delivery of snacks (Dietary Supplement)
Outcomes
Primary Outcomes
Caries risk reduction
Time Frame: 42 days
calculation of the carie risk reduct using a standardised method aka "Cariogram"
reduction of salivary cariogenic bacteria
Time Frame: 42 days
reduction of salivary cariogenic bacteria of one level eg from 1000000 to 10000 CFU/ml
Secondary Outcomes
- modification of the plaque-pH(42 days)
Investigators
Guglielmo Campus
Associate Professor of Community Dentistry and Oral Epidemiology
Università degli Studi di Sassari