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Completed

NCT Number: NCT03724864

Edulcorants Effect in Caries Risk Schoolchildren

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric dentistry dept

Sassari, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Caries risk reduction

    Time frame: 42 days

    calculation of the carie risk reduct using a standardised method aka "Cariogram"

  2. reduction of salivary cariogenic bacteria

    Time frame: 42 days

    reduction of salivary cariogenic bacteria of one level eg from 1000000 to 10000 CFU/ml

Secondary outcomes

  1. modification of the plaque-pH

    Time frame: 42 days

    reduction of the Area Under the Curve (AUC) at the critical level of pH of 6.2 and 5.7

Sponsors and collaborators

Lead sponsor

Università degli Studi di Sassari

Other

Registry information

Official study title

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

Acronym: STEVIA

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Oct 30, 2018
Registry last updated
Oct 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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