Plain English Summary
Background and study aims
Inequalities in oral health are related to socioeconomic factors. Stop Caries Stockholm is a study in multicultural less privileged areas which aims to prevent tooth decay in preschool children by introducing a fluoride-based preventive treatment.
Who can participate?
About 4000 children are invited to participate in the study.
What does the study involve?
Children are randomly allocated to one of two groups. One group receives a fluoride varnish application on their teeth when they are 12 months old. The other group receives standard care.
What are the possible benefits and risks of participating?
The benefit is fewer dental caries in the future. No known risks exist with this protocol.
Where is the study run from?
It is a collaborative project between department of Dental Medicine and Centre for Health Equity Studies at Karolinska Institute, Public Dental Service in Stockholm, as well as private clinics.
When is the study starting and how long is it expected to run for?
April 2011 to March 2014.
Who is funding the study?
Stockholm County Council and Karolinska Institute (Sweden)
Who is the main contact?
Dr. Margaret Grindefjord
Margaret.grindefjord@ftv.sll.se
Trial website
Contact information
Type
Scientific
Primary contact
Dr Margaret Grindefjord
ORCID ID
Contact details
Dalagatan 11
Stockholm
SE-11324
Sweden
+46 8 12316536
margaret.grindefjord@ftv.sll.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
A caries prevention program to preschool children living in multicultural, low socio-economic areas of Stockholm
Acronym
SCS
Study hypothesis
Children, 1-year of age, subjected to a fluoride-based preventive program will develop fewer dental caries than children in a control group.
Ethics approval
Regional ethics committee (EPN), January 19, 201, Dnr 2010/1956-31/4.
Study design
Cluster-randomised controlled trial with a prospective and longitudinal design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Dental caries
Intervention
The participants are divided into two treatment arms using a cluster-randomized design. All children have their first examination at 12 month.
Children in the test group clinics receive a fluoride varnish application on their teeth on each visit in an extended program.
In the reference group clinics the children receive examinations according to the standard preventive program in Stockholm.
The examinations are repeated at 24 and 36 month in the reference group clinics and at 18, 24, 30 and 36 month in the test group clinics. Both the test group and the reference group will be examined at 84 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Dental caries - The international caries detection system (ICDAS) is used to diagnose caries.
Measured at baseline, after one year, two years and after six years. In the test group the primary outcome will also be measured after one and a half year and after two and a half year.
Secondary outcome measures
1. Tooth brushing habits
2. Cost effectiveness
3. Caries progression
Measured at baseline, after one year, two years and after six years
Overall trial start date
01/04/2011
Overall trial end date
31/03/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All children born in 2010 living in 23 multicultural low socioeconomic areas of Stockholm are invited to participate in the study.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
4000
Participant exclusion criteria
Does not meet inclusion criteria.
Recruitment start date
01/04/2011
Recruitment end date
31/03/2014
Locations
Countries of recruitment
Sweden
Trial participating centre
Dalagatan 11
Stockholm
SE-11324
Sweden
Sponsor information
Organisation
Stockholm County Council (Sweden)
Sponsor details
Hantverkargatan 11
Stockholm
SE-113 82
Sweden
+46 8 12313381
kjell.bjerrehorn@sll.se
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Stockholm County Council (Sweden)
Alternative name(s)
Stockholm County Council
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Sweden
Funder name
Karolinska Institutet (Sweden)
Alternative name(s)
Karolinska Institute, KI
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Sweden
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 results in https://www.ncbi.nlm.nih.gov/pubmed/26795957