Edulcorants Effect in Caries Risk Schoolchildren

NCT03724864 | Completed

• 1 other identifier: 1138/L
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• modification of the plaque-pH

  42 days

Study Arms (3)

Stevia snacks

EXPERIMENTAL

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

Maltitol snacks

ACTIVE COMPARATOR

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

Sugared snacks

PLACEBO COMPARATOR

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

Interventions

delivery of snacks DIETARY_SUPPLEMENT

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.

Maltitol snacks; Stevia snacks; Sugared snacks

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Subjects with a history of systemic diseases and antibiotic therapy within 30 days before baseline were excluded.

Sponsors & Collaborators

• Università degli Studi di Sassari: lead

Study Sites (1)

Pediatric dentistry dept

Sassari, Italy

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Community Dentistry and Oral Epidemiology

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 30, 2018
• Study Start: February 1, 2017
• Primary Completion: June 30, 2017
• Study Completion: May 8, 2018
• Last Updated: October 30, 2018

Record last verified: 2018-10

Locations

IT (1)