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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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OMON |
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Last refreshed on:
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28 February 2024 |
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Main ID: |
NL-OMON20892 |
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Date of registration:
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2015-12-01 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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GigaGaaf!
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Scientific title:
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Healthy teeth: all aboard!
Effectiveness of a community-based
intervention to promote oral health of
preschool children in The Netherlands |
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Date of first enrolment:
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2015-06-15 |
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Target sample size:
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1000 |
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Recruitment status: |
Recruiting |
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URL:
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https://onderzoekmetmensen.nl/en/trial/20892 |
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Study type:
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Interventional |
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Study design:
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Non-randomized controlled trial, Open (masking not used), Placebo, Parallel
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Phase:
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Contacts
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Name:
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D.A.
Verlinden |
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Address:
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9713 AV
Groningen
The Netherlands |
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Telephone:
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+31888660918 |
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Email:
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d.a.verlinden@umcg.nl |
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Affiliation:
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Antonius Deusinglaan
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Name:
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D.A.
Verlinden |
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Address:
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9713 AV
Groningen
The Netherlands |
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Telephone:
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+31888660918 |
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Email:
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d.a.verlinden@umcg.nl |
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Affiliation:
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Antonius Deusinglaan
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Key inclusion & exclusion criteria
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Inclusion criteria: Children aged 4 to 11 months who routinely visit the well-baby clinics in specific deprived areas in the Province of Groningen and specific
deprived areas in the city of The Hague.
Exclusion criteria: Parents who do not have sufficient mastery of the Dutch or English language to fill out the questionnaires.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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caries, tooth brushing, socioeconomic status, diet, bottle feeding, sugar intake.
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Intervention(s)
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The GigaGaaf! intervention consists of 1); A referral from the well-baby clinic physician to a dental clinic for the first preventive dental
appointment between ages 4-12 months and education about the importance of this first appointment and 2) Providing supervision from
an oral health professional who works according to the Non Operative Caries Treatment Programme (NOCTP). NOCTP is an individualized caries prevention program wherein the recall interval is individually assessed based on the risk criteria: 1) caries progression; and 2) parents’ motivation and compliance to favorable behavior regarding oral health regarding brushing teeth with fluoride toothpaste, brushing/additional
brushing by parents, and limiting the frequency of eating and drinking and healthy child nutrition.
Control condition: The control condition consists of care as usual, which is dental care starting at varying ages (but usually not before the age of 2 years), with next mostly visits of the dental clinic once every half year.
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Primary Outcome(s)
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a) Caries experience measured based on the
International Caries Detection and Assessment
System (ICDAS) and Nyvad criteria.
b) Parental knowledge and behavior regarding
oral health of the child.
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Secondary Outcome(s)
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a) Parental attitude regarding oral health of the child
b) Costs
c) Impact of Covid-19 period on parental oral health behavior regarding oral health of the child
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Secondary ID(s)
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- : 200199501
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NL4174
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NTR5587
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Source(s) of Monetary Support
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ZonMw
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Ethics review
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Status: Not applicable
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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