Edulcorants Effect in Caries Risk Schoolchildren

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.

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

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Dietary Supplement: delivery of snacks


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 8 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stevia snacks<br>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<br>* 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.<br>|
| Active Comparator: Maltitol snacks<br>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<br>* 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.<br>|
| Placebo Comparator: Sugared snacks<br>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<br>* 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.<br>|

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 |