Edulcorants Effect in Caries Risk Schoolchildren

NCT ID: NCT03724864

Last Updated: 2018-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

271 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-05-08

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Stevia snacks

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

Group Type EXPERIMENTAL

delivery of snacks

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

delivery of snacks

Intervention Type 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.

Sugared snacks

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

Group Type PLACEBO_COMPARATOR

delivery of snacks

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Università degli Studi di Sassari

OTHER

Sponsor Role lead

Responsible Party

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Guglielmo Campus

Associate Professor of Community Dentistry and Oral Epidemiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pediatric dentistry dept

Sassari, , Italy

Site Status

Countries

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Italy

Other Identifiers

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1138/L

Identifier Type: -

Identifier Source: org_study_id

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