Edulcorants Effect in Caries Risk Schoolchildren

Dental Caries Clinical Trial

— STEVIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03724864
• Other study ID #: 1138/L
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: May 8, 2018

Study information

• Verified date: October 2018
• Source: Università degli Studi di Sassari
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: May 8, 2018
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries

Intervention

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.

Locations

Country	Name	City	State
Italy	Pediatric dentistry dept	Sassari

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Sassari

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caries risk reduction	calculation of the carie risk reduct using a standardised method aka "Cariogram"	42 days
Primary	reduction of salivary cariogenic bacteria	reduction of salivary cariogenic bacteria of one level eg from 1000000 to 10000 CFU/ml	42 days
Secondary	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