Dental CariesSTEVIANCT03724864
Edulcorants Effect in Caries Risk Schoolchildren
A study testing delivery of snacks in people with Dental Caries, run by Università degli Studi di Sassari at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- delivery of snacks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 271 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2017to 8 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Subjects with a history of systemic diseases and antibiotic therapy within 30 days before baseline were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Daily Dose of Snacks Containing Mannitol or Stevia Rebaudiana as Sweeteners in High 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.
- Conditions
- Dental Caries
- Being tested
- delivery of snacks
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delivery of snacksDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: delivery of snacks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries risk reduction
calculation of the carie risk reduct using a standardised method aka "Cariogram"
Measured: 42 days
reduction of salivary cariogenic bacteria
reduction of salivary cariogenic bacteria of one level eg from 1000000 to 10000 CFU/ml
Measured: 42 days
Secondary outcomes (1)
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
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start1 Feb 2017
- Primary completion30 Jun 2017
- Study completion8 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Sassari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guglielmo Campus, Università degli Studi di Sassari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724864
- Sponsor's protocol ID
- 1138/L
- Acronym
- STEVIA
- Status last verified
- Oct 2018
- First submitted
- 25 Oct 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Daily Dose of Snacks Containing Mannitol or Stevia Rebaudiana as Sweeteners in High Caries Risk Schoolchildren
- ClinicalTrials.gov ID
- NCT03724864
- Acronym / sponsor ID
- STEVIA / 1138/L
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Università degli Studi di SassariUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 8 May 2018 (actual)
- First posted
- 30 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stevia snacks | Experimental | Dietary Supplement: delivery of snacksChildren were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks. |
| Maltitol snacks | Active comparator | Dietary Supplement: delivery of snacksChildren were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks. |
| Sugared snacks | Placebo comparator | Dietary Supplement: delivery of snacksChildren were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects with a history of systemic diseases and antibiotic therapy within 30 days before baseline were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| delivery of snacksSubjects 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. | Dietary supplement | Maltitol snacks, Stevia snacks, Sugared snacks |
Primary outcome
Caries risk reduction
Time frame: 42 days
calculation of the carie risk reduct using a standardised method aka "Cariogram"
reduction of salivary cariogenic bacteria
Time frame: 42 days
reduction of salivary cariogenic bacteria of one level eg from 1000000 to 10000 CFU/ml
1 secondary outcome
modification of the plaque-pH
Time frame: 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing delivery of snacks in people with Dental Caries, run by Università degli Studi di Sassari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries risk reduction (time frame: 42 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018; AzTrials last refreshed its copy on 27 Oct 2026.