Condition category
Oral Health
Date applied
19/08/2013
Date assigned
16/12/2013
Last edited
14/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.stopcariesstockholm.se/

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 measures

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

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

http://www.sll.se/

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

Results - basic reporting

Publication summary

2016 results in https://www.ncbi.nlm.nih.gov/pubmed/26795957

Publication citations

Additional files

Editorial Notes

14/11/2016: Publication reference added.