Stop Caries Stockholm
| ISRCTN | ISRCTN35086887 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35086887 |
| Secondary identifying numbers | 1 |
- 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
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
Scientific
Dalagatan 11
Stockholm
SE-11324
Sweden
| Phone | +46 8 12316536 |
|---|---|
| margaret.grindefjord@ftv.sll.se |
Study information
| Study design | Cluster-randomised controlled trial with a prospective and longitudinal design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/04/2011 |
| Completion date | 31/03/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 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
SE-11324
Sweden
Sponsor information
Government
Hantverkargatan 11
Stockholm
SE-113 82
Sweden
| Phone | +46 8 12313381 |
|---|---|
| kjell.bjerrehorn@sll.se | |
| Website | http://www.sll.se/ |
"ROR" |
https://ror.org/02zrae794 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Stockholm County Council
- Location
- Sweden
Government organisation / Local government
- Alternative name(s)
- Karolinska Institute, KI
- Location
- Sweden
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
14/11/2016: Publication reference added.
