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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- ISRCTNISRCTN no longer applicable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!
Effectiveness of a community-based intervention to promote oral health of preschool children in The Netherlands
- ACRONYMHTAA
- hypothesisChildren aged 4 to 6 years in the intervention group who have received the GigaGaaf! intervention have a different oral health than children aged 4 to 6 years from the control group who have received care as usual. Parents of the children aged 4 to 6 years who have received the GigaGaaf! intervention have different knowledge and behavior regarding oral health of their child than parents of children aged 4 to 6 years who have received care as usual group.
- 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 closingdate10-jul-2022
- Target number of participants1000
- 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, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsNone
- Brief summaryThe purpose of the study is to evaluate the effect of a community-based intervention named “GigaGaaf!”. The intervention aims to promote oral health of children aged 4 to 11 months to 4-6 years. Participants are children aged 4 to 11 months and their parents in two regions, i.e. the province of Groningen (mainly low socioeconomic status, Dutch origin) and the city of The Hague (mainly low socioeconomic status, varying ethnic background). In both regions, both intervention- and control-group will be composed. Children in the intervention-group receive the GigaGaaf! Intervention and children in the control-group receive care as usual. The follow-up is until ages 4 to 6 years.

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.

Care as usual 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.

The evaluation consists of:
1 ) an effect evaluation relating to caries experience of children measured by ICDAS and Nyvad criteria at the age of 4 to 6 years and parental knowledge and behavior regarding oral health measured by a questionnaire at the ages of 6 months, 2 years, and 4 to 6 years to explore if there is a difference between the intervention and control group;
2 ) a cost-effectiveness analysis.
- 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).



15-mei-2018 -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 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."

replaced by

"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:
"None"

replaced by

"Parents who do not have sufficient mastery of the Dutch or English language to fill out the questionnaires."


Intervention:
"GigaGaaf! 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)."

replaced by

"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."


Primary outcome:
"a)clinical oral health
b) knowledge and behavior regarding oral health
c) cost-effectiveness
d) process outcomes"

replaced by

"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."


Secondary outcome:
"a) age child
b) age mother
c) socioeconomic status mother
d) ethnicity
e) children in household"

replaced by

"a) Parental attitude regarding oral health of the child
b) Costs"


Timepoints:
"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)."

replaced by

"Measurements (of knowledge/behavior) at child ages 6 months (T1: 2015-2016), 2 years (T2: 2017-2018) and 4 to 6 years (T3: 2020). Caries experience measurements at 4 to 6 years (T3: 2020)."
- RECORD1-dec-2015 - 16-mei-2018


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