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NCT00530153 Clinical Trial

School Intervention Study of Nutrition, Wellbeing and Dental Health

Oral Health Clinical Trial

Official title:
School Intervention Study of Nutrition, Wellbeing and Dental Health

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00530153
Other study ID # KTL 369-3
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 14, 2007
Last updated September 29, 2009
Start date April 2007
Est. completion date May 2008

Study information
Verified date September 2009
Source National Institute for Health and Welfare, Finland
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects of an intervention programme on dietary intake and dental health of 8th grade students.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 769
Est. completion date May 2008
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 13 Years to 14 Years
Eligibility Inclusion Criteria:

- 7th grade students from the participating schools, written informed consent both from the student and the parent

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• dietary counseling
Various activities and materials for teachers, students, parents and school catering personnel aiming at increasing their awareness and knowledge of good nutrition.
Dietary Supplement:
• xylitol
Delivery of xylitol lozenges (about 1 g xylitol/student/school day) and guidance on tooth brushing.

Locations
Country Name City State
Finland National Public Health Institute Helsinki

Sponsors (3)
Lead Sponsor Collaborator
National Institute for Health and Welfare, Finland Sitra, the Finnish Innovation Fund, University of Oulu, Department of dental health

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dietary intake (eg. sugar, fibre). The presence of active initial caries lesions.
Secondary Nutritional quality of school meals and snacks. Laser fluorescence values of the occlusal surfaces of permanent molar and premolar teeth.
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