STEVIA: Edulcorants Effect in Caries Risk Schoolchildren

Sponsor

Università degli Studi di Sassari (Other)

Overall Status

Completed

CT.gov ID

NCT03724864

Collaborator

(none)

271

Enrollment

Location

Arms

15.1

Actual Duration (Months)

17.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Dietary Supplement: delivery of snacks	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

271 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 1, 2017

Actual Primary Completion Date :

Jun 30, 2017

Actual Study Completion Date :

May 8, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stevia snacks 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 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.
Active Comparator: Maltitol snacks 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 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.
Placebo Comparator: Sugared snacks 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 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.

Arm

Intervention/Treatment

Experimental: Stevia snacks

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

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.

Active Comparator: Maltitol snacks

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

Placebo Comparator: Sugared snacks

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

Outcome Measures

Primary Outcome Measures

Caries risk reduction [42 days]
calculation of the carie risk reduct using a standardised method aka "Cariogram"
reduction of salivary cariogenic bacteria [42 days]
reduction of salivary cariogenic bacteria of one level eg from 1000000 to 10000 CFU/ml

Secondary Outcome Measures

modification of the plaque-pH [42 days]
reduction of the Area Under the Curve (AUC) at the critical level of pH of 6.2 and 5.7

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pediatric dentistry dept	Sassari		Italy

Sponsors and Collaborators

Università degli Studi di Sassari

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guglielmo Campus, Associate Professor of Community Dentistry and Oral Epidemiology, Università degli Studi di Sassari

ClinicalTrials.gov Identifier:

NCT03724864

Other Study ID Numbers:

1138/L

First Posted:

Oct 30, 2018

Last Update Posted:

Oct 30, 2018

Last Verified:

Oct 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Oct 30, 2018