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GigaGaaf!


- candidate number23445
- NTR NumberNTR5587
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-dec-2015
- Secondary IDs200199501 
- Public TitleGigaGaaf!
- Scientific TitleHealthy teeth: all aboard!
- ACRONYMHTAA
- hypothesisChildren aged 5 years in the intervention group who received the GigaGaaf! intervention have a better oral health than children aged 5 years from the control group who received care as usual.
- Healt Condition(s) or Problem(s) studiedCaries, Diet
- Inclusion criteriachildren aged 6 months who visit the well-baby clinic in Oldambt, The Hague-Paviljoensgracht and The Hague-Zonneoord. Children aged 4, 6 and 11 months in Veendam. Control group: Children aged 6 months who visit the well-baby clinic in Stadskanaal, The Hague-Segbroek and The Hague-Laak. Children aged 4,6 and 11 months who visit the well-baby clinic in Hoogezand.
- Exclusion criteriaNone
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 15-jun-2015
- planned closingdate21-mrt-2021
- Target number of participants500
- InterventionsGigaGaaf! will target young children and their parents by means of 1) extensive dissemination of the preventive messages: brushing teeth with fluoride toothpaste, brushing/additional brushing by parents, and limiting the frequency of eating and drinking and 2) getting supervision into place at a very young age from an oral health professional who informs and helps the parents and, if necessary, offers additional support. The oral health professional will carry out the Non Operative Caries Treatment Programme (NOCTP).
- Primary outcomea)clinical oral health
b) knowledge and behavior regarding oral health
c) cost-effectiveness
d) process outcomes
- Secondary outcomea) age child
b) age mother
c) socioeconomic status mother
d) ethnicity
e) children in household
- Timepointschildren in the intervention- and control group aged 6 months (2015-2016), 2 years (2017-2018) and 5 years (2020-2021).
- Trial web sitewww.kindergebit.umcg.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMsc. D.A. Verlinden
- CONTACT for SCIENTIFIC QUERIESMsc. D.A. Verlinden
- Sponsor/Initiator University Medical Center Groningen (UMCG), TNO, Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsNone
- Brief summary“Healthy teeth: all aboard!” with East Groningen and The Hague as pilot regions for better oral health in young children has been granted by ZonMw!

The purpose of “Healthy teeth: all aboard!” is to evaluate a community-based (Combas) approach to promote oral health of young children wherein oral health professionals, obstetricians (planned), pediatricians and nurses working together through referral from the health (co)workers to the oral health professionals. The oral health professionals follow the Non Operative Caries Treatment Program (NOCTP). Participants are young children and their parents in the province of Groningen (mainly low socioeconomic status, Dutch origin) and in The Hague (mainly low socioeconomic status, different ethnicities), where both intervention- and control-group will be composed. Children in the intervention-group receive the Combas approach and children in the control-group receive care as usual.

The study consists of:
1 ) an effect evaluation relating to oral health of children and the knowledge and behavior of the parents,
2 ) a cost-effectiveness analysis, and
3 ) a process evaluation.
- Main changes (audit trail)16-nov-2017 -IK:

Inclusion criteria:
children aged 6 months who visit the well-baby clinic in Oldambt, The Hague-Paviljoensgracht and The Hague-Zonneoord. Children aged 4, 6 and 11 months in Veendam.
Control group: Children aged 6 months who visit the well-baby clinic in Stadskanaal, The Hague-Segbroek and The Hague-Laak. Children aged 4,6 and 11 months who visit the well-baby clinic in Hoogezand.

replaced by

children aged 6 months who visit the well-baby clinic in Oldambt, The Hague-Paviljoensgracht and The Hague-Zonneoord. Children aged 4, 6 and 11 months in Veendam and Coevorden.
Control group: Children aged 6 months who visit the well-baby clinic in Stadskanaal, Delfzijl, Appingedam, Loppersum, The Hague- Segbroek and The Hague-Laak. Children aged 4,6 and 11 months who visit the well-baby clinic in Hoogezand.


Timepoints:
children in the intervention- and control group aged 6 months (2015-2016), 2 years (2017-2018) and 5 years (2020-2021).

replaced by

children in the intervention- and control group aged 6 months (2015-2016), 2 years (2017- 2018) and 5 years (2020-2021).children aged 5 years in control region Delfzijl, Hoogezand and Appingedam (2017).
- RECORD1-dec-2015 - 16-nov-2017


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