Edulcorants Effect in Caries Risk Schoolchildren (STEVIA)

Università degli Studi di Sassari

Status: Completed

Conditions: Dental Caries

Treatments: Dietary Supplement: delivery of snacks

Study type: Interventional

Funder types: Other

Identifiers

NCT03724864

1138/L

Details and patient eligibility

About

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.

Enrollment: 271 patients

Sex: All

Ages: 6 to 8 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

271 participants in 3 patient groups, including a placebo group

Stevia snacks

Experimental group

Description:

Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks.

Treatment:

Dietary Supplement: delivery of snacks

Maltitol snacks

Active Comparator group

Description:

Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks.

Treatment:

Dietary Supplement: delivery of snacks

Sugared snacks

Placebo Comparator group

Description:

Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks.

Treatment:

Dietary Supplement: delivery of snacks