Stop Caries Stockholm

ISRCTN	ISRCTN35086887
DOI	https://doi.org/10.1186/ISRCTN35086887
Protocol serial number	1
Sponsor	Stockholm County Council (Sweden)
Funders	Stockholm County Council (Sweden), Karolinska Institutet (Sweden)

Submission date: 19/08/2013
Registration date: 16/12/2013
Last edited: 14/11/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Margaret Grindefjord
Scientific

Dalagatan 11
Stockholm
SE-11324
Sweden

Phone	+46 8 12316536
Email	margaret.grindefjord@ftv.sll.se

Study information

Primary study design	Interventional
Study design	Cluster-randomised controlled trial with a prospective and longitudinal design
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A caries prevention program to preschool children living in multicultural, low socio-economic areas of Stockholm
Study acronym	SCS
Study objectives	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(s)	Regional ethics committee (EPN), January 19, 201, Dnr 2010/1956-31/4.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	1. Tooth brushing habits 2. Cost effectiveness 3. Caries progression Measured at baseline, after one year, two years and after six years
Completion date	31/03/2014

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	4000
Key inclusion criteria	All children born in 2010 living in 23 multicultural low socioeconomic areas of Stockholm are invited to participate in the study.
Key exclusion criteria	Does not meet inclusion criteria.
Date of first enrolment	01/04/2011
Date of final enrolment	31/03/2014

Locations

Countries of recruitment

Sweden

Study participating centre

Dalagatan 11

Stockholm
SE-11324
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/11/2016: Publication reference added.