NCT03724864

Edulcorants Effect in Caries Risk Schoolchildren

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: Università degli Studi di Sassari · Academic / Other
• Sex: All
• Age: 6 Years – 8 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Caries

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-02-01
• Primary completion: 2017-06-30
• Completion: 2018-05-08
• First posted: 2018-10-30
• Last updated: 2018-10-30

Locations

1 site across 1 country: Italy