Oral Health Coaches at Well-Baby Clinics to Promote Oral Health in Preschool Children From the First Erupted Tooth: Protocol for a Multisite, Pragmatic Randomized Controlled Trial
BackgroundEarly childhood caries is considered one of the most prevalent diseases in childhood, affecting almost half of preschool-age children globally. In the Netherlands, approximately one-third of children aged 5 years already have dental caries, and dental care providers...
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| Format: | Article |
| Language: | English |
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JMIR Publications
2022-08-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2022/8/e39683 |
| _version_ | 1797734796004163584 |
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| author | Peggy C J M van Spreuwel Katarina Jerković-Ćosić Cor van Loveren Geert J M G van der Heijden |
| author_facet | Peggy C J M van Spreuwel Katarina Jerković-Ćosić Cor van Loveren Geert J M G van der Heijden |
| author_sort | Peggy C J M van Spreuwel |
| collection | DOAJ |
| description |
BackgroundEarly childhood caries is considered one of the most prevalent diseases in childhood, affecting almost half of preschool-age children globally. In the Netherlands, approximately one-third of children aged 5 years already have dental caries, and dental care providers experience problems reaching out to these children.
ObjectiveWithin the proposed trial, we aim to test the hypothesis that, compared to children who receive usual care, children who receive the Toddler Oral Health Intervention as add-on care will have a reduced cumulative caries incidence and caries incidence density at the age of 48 months.
MethodsThis pragmatic, 2-arm, individually randomized controlled trial is being conducted in the Netherlands and has been approved by the Medical Ethics Research Board of University Medical Center Utrecht. Parents with children aged 6 to 12 months attending 1 of the 9 selected well-baby clinics are invited to participate. Only healthy children (ie, not requiring any form of specialized health care) with parents that have sufficient command of the Dutch language and have no plans to move outside the well-baby clinic region are eligible. Both groups receive conventional oral health education in well-baby clinics during regular well-baby clinic visits between the ages of 6 to 48 months. After concealed random allocation of interventions, the intervention group also receives the Toddler Oral Health Intervention from an oral health coach. The Toddler Oral Health Intervention combines behavioral interventions of proven effectiveness in caries prevention. Data are collected at baseline, at 24 months, and at 48 months. The primary study endpoint is cumulative caries incidence for children aged 48 months, and will be analyzed according to the intention-to-treat principle. For children aged 48 months, the balance between costs and effects of the Toddler Oral Health Intervention will be evaluated, and for children aged 24 months, the effects of the Toddler Oral Health Intervention on behavioral determinants, alongside cumulative caries incidence, will be compared.
ResultsThe first parent-child dyads were enrolled in June 2017, and recruitment was finished in June 2019. We enrolled 402 parent-child dyads.
ConclusionsAll follow-up interventions and data collection will be completed by the end of 2022, and the trial results are expected soon thereafter. Results will be shared at international conferences and via peer-reviewed publication.
Trial RegistrationNetherlands Trial Register NL8737; https://trialsearch.who.int/Trial2.aspx?TrialID=NL8737
International Registered Report Identifier (IRRID)DERR1-10.2196/39683 |
| first_indexed | 2024-03-12T12:49:39Z |
| format | Article |
| id | doaj.art-82ddfb60643141e8b837fa599f6ef293 |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-03-12T12:49:39Z |
| publishDate | 2022-08-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-82ddfb60643141e8b837fa599f6ef2932023-08-28T22:59:02ZengJMIR PublicationsJMIR Research Protocols1929-07482022-08-01118e3968310.2196/39683Oral Health Coaches at Well-Baby Clinics to Promote Oral Health in Preschool Children From the First Erupted Tooth: Protocol for a Multisite, Pragmatic Randomized Controlled TrialPeggy C J M van Spreuwelhttps://orcid.org/0000-0001-6815-5162Katarina Jerković-Ćosićhttps://orcid.org/0000-0001-6921-2798Cor van Loverenhttps://orcid.org/0000-0002-3588-2977Geert J M G van der Heijdenhttps://orcid.org/0000-0003-4979-2099 BackgroundEarly childhood caries is considered one of the most prevalent diseases in childhood, affecting almost half of preschool-age children globally. In the Netherlands, approximately one-third of children aged 5 years already have dental caries, and dental care providers experience problems reaching out to these children. ObjectiveWithin the proposed trial, we aim to test the hypothesis that, compared to children who receive usual care, children who receive the Toddler Oral Health Intervention as add-on care will have a reduced cumulative caries incidence and caries incidence density at the age of 48 months. MethodsThis pragmatic, 2-arm, individually randomized controlled trial is being conducted in the Netherlands and has been approved by the Medical Ethics Research Board of University Medical Center Utrecht. Parents with children aged 6 to 12 months attending 1 of the 9 selected well-baby clinics are invited to participate. Only healthy children (ie, not requiring any form of specialized health care) with parents that have sufficient command of the Dutch language and have no plans to move outside the well-baby clinic region are eligible. Both groups receive conventional oral health education in well-baby clinics during regular well-baby clinic visits between the ages of 6 to 48 months. After concealed random allocation of interventions, the intervention group also receives the Toddler Oral Health Intervention from an oral health coach. The Toddler Oral Health Intervention combines behavioral interventions of proven effectiveness in caries prevention. Data are collected at baseline, at 24 months, and at 48 months. The primary study endpoint is cumulative caries incidence for children aged 48 months, and will be analyzed according to the intention-to-treat principle. For children aged 48 months, the balance between costs and effects of the Toddler Oral Health Intervention will be evaluated, and for children aged 24 months, the effects of the Toddler Oral Health Intervention on behavioral determinants, alongside cumulative caries incidence, will be compared. ResultsThe first parent-child dyads were enrolled in June 2017, and recruitment was finished in June 2019. We enrolled 402 parent-child dyads. ConclusionsAll follow-up interventions and data collection will be completed by the end of 2022, and the trial results are expected soon thereafter. Results will be shared at international conferences and via peer-reviewed publication. Trial RegistrationNetherlands Trial Register NL8737; https://trialsearch.who.int/Trial2.aspx?TrialID=NL8737 International Registered Report Identifier (IRRID)DERR1-10.2196/39683https://www.researchprotocols.org/2022/8/e39683 |
| spellingShingle | Peggy C J M van Spreuwel Katarina Jerković-Ćosić Cor van Loveren Geert J M G van der Heijden Oral Health Coaches at Well-Baby Clinics to Promote Oral Health in Preschool Children From the First Erupted Tooth: Protocol for a Multisite, Pragmatic Randomized Controlled Trial JMIR Research Protocols |
| title | Oral Health Coaches at Well-Baby Clinics to Promote Oral Health in Preschool Children From the First Erupted Tooth: Protocol for a Multisite, Pragmatic Randomized Controlled Trial |
| title_full | Oral Health Coaches at Well-Baby Clinics to Promote Oral Health in Preschool Children From the First Erupted Tooth: Protocol for a Multisite, Pragmatic Randomized Controlled Trial |
| title_fullStr | Oral Health Coaches at Well-Baby Clinics to Promote Oral Health in Preschool Children From the First Erupted Tooth: Protocol for a Multisite, Pragmatic Randomized Controlled Trial |
| title_full_unstemmed | Oral Health Coaches at Well-Baby Clinics to Promote Oral Health in Preschool Children From the First Erupted Tooth: Protocol for a Multisite, Pragmatic Randomized Controlled Trial |
| title_short | Oral Health Coaches at Well-Baby Clinics to Promote Oral Health in Preschool Children From the First Erupted Tooth: Protocol for a Multisite, Pragmatic Randomized Controlled Trial |
| title_sort | oral health coaches at well baby clinics to promote oral health in preschool children from the first erupted tooth protocol for a multisite pragmatic randomized controlled trial |
| url | https://www.researchprotocols.org/2022/8/e39683 |
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