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School Intervention Study of Nutrition, Wellbeing and Dental Health

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by National Institute for Health and Welfare, Finland.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00530153
First Posted: September 17, 2007
Last Update Posted: September 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Oulu, Department of dental health
Sitra, the Finnish Innovation Fund
Information provided by:
National Institute for Health and Welfare, Finland
  Purpose
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 Intervention
Eating Oral Health Behavioral: dietary counseling Dietary Supplement: xylitol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: School Intervention Study of Nutrition, Wellbeing and Dental Health

Resource links provided by NLM:


Further study details as provided by National Institute for Health and Welfare, Finland:

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

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

Enrollment: 769
Study Start Date: April 2007
Estimated Study Completion Date: May 2008
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: September 14, 2007
First Posted: September 17, 2007
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