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School Intervention Study of Nutrition, Wellbeing and Dental Health

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ClinicalTrials.gov Identifier: NCT00530153
Recruitment Status : Unknown
Verified September 2009 by National Institute for Health and Welfare, Finland.
Recruitment status was:  Active, not recruiting
First Posted : September 17, 2007
Last Update Posted : September 30, 2009
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
Eating Oral Health Behavioral: dietary counseling Dietary Supplement: xylitol

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 769 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: School Intervention Study of Nutrition, Wellbeing and Dental Health
Study Start Date : April 2007
Estimated Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health
Drug Information available for: Xylitol
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    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.

Outcome Measures

Primary Outcome Measures :
  1. Dietary intake (eg. sugar, fibre). The presence of active initial caries lesions.

Secondary Outcome Measures :
  1. Nutritional quality of school meals and snacks. Laser fluorescence values of the occlusal surfaces of permanent molar and premolar teeth.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530153


Locations
Finland
National Public Health Institute
Helsinki, Finland, 00300
Sponsors and Collaborators
National Institute for Health and Welfare, Finland
University of Oulu, Department of dental health
Sitra, the Finnish Innovation Fund
Investigators
Principal Investigator: Pirjo Pietinen, Ph. D National Public Health Institute
More Information

ClinicalTrials.gov Identifier: NCT00530153     History of Changes
Other Study ID Numbers: KTL 369-3
First Posted: September 17, 2007    Key Record Dates
Last Update Posted: September 30, 2009
Last Verified: September 2009

Keywords provided by National Institute for Health and Welfare, Finland:
Eating
Food Habits
Adolescent
Dental Research