Gezonde Peutermonden

Toddler Oral Health Project - The effect of an oral health coach at health-baby clinics to promote oral health in preschool children from first teeth: a multicenter pragmatic randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25790

Enrollment

400

Registered

2020-06-24

Start date

2017-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental caries

Interventions

At all health-baby clinics both an intervention- and a control group are present. At the age of 8 (± 3) months, preferably with the eruption of the first primary teeth, all parent-child dyads in the

- Oral health risk-assessment to evaluate the previous period and to determine recall interval

- Assessing parents' phase of behavioral change with respect to oral health self-care, analyzing barriers for healthy behavior using psychosocial determinants from the HAPA model

- Make an health plan for the next period

- Upon detection of incipient caries, fluoride is applied to the lesion

- When caries progress and require treatment, referral to a dental office. The oral risk assessment will be based on: Nexø en HAPA: 1. Visible amount

Eligibility

Inclusion criteria

Inclusion criteria: - Children aged 8 (± 3) months; - Both parents (or person with legal parental authority) has signed the informed consent form.

Exclusion criteria

Exclusion criteria: - Children with any medically compromised condition, physical- or mental handicap in need of specialty health care; - Parents who insufficiently speak and understand the Dutch language.

Design outcomes

Primary

Measure	Time frame
The study primary study outcome at the age of 48 (± 3) months is caries experience expressed as the proportion of children with one or more caries lesions and the average number of tooth surfaces affected by caries (ECC-index/modified ICDAS).	—

Secondary

Measure	Time frame
Other outcome measures for this study at the age of 48 (± 3) months are: - Proportion of children with one or more caries-related inflammations (pufa-index); - Behavioral determinants of the parent: knowledge, risk perception, action self-efficacy, intention, action planning, coping planning and coping self-efficacy (HAPA model); - Parental behavior regarding oral health of the child and themselves; - Time to first caries lesion (caries free survival time); - Plaque score (Simplified Oral Hygiene - index; - Oral health related quality of life (ECOHIS).	—

Measure

Time frame

Other outcome measures for this study at the age of 48 (± 3) months are: - Proportion of children with one or more caries-related inflammations (pufa-index); - Behavioral determinants of the parent: knowledge, risk perception, action self-efficacy, intention, action planning, coping planning and coping self-efficacy (HAPA model); - Parental behavior regarding oral health of the child and themselves; - Time to first caries lesion (caries free survival time); - Plaque score (Simplified Oral Hygiene - index; - Oral health related quality of life (ECOHIS).

—

Contacts

Public ContactPeggy van Spreuwel

Hogeschool Utrecht

Peggy.vanspreuwel@hu.nl+31654391441

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)