The objective of this study is to contribute to evidence based intervention to optimize dental care for preschool children, and deliver evidence of feasibility and (cost-)effectiveness of this innovative intervention in which an oral health coach is…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cariës
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study outcome is the oral health of children in terms of cariouslesions
(dmfs/dmft)) at 72 months
Secondary outcome
Secondary outcome measures are: number of inflammations related to
caries-related in the mouth (pufa); change in oral health behavior; cariesfree
survival time; plaque scores and oral health related quality of life at 72
months.
Other outcome measures are process outcomes: caries risk score for each
consultation, duration of consultations, number of visits per child, cost of
care (hours and materials (fluoride, restorations, etc.), time (indirect) costs
that the parent is lost through visits to oral health coach or visit dental
care professionals in practice.
When the child is 24 and 45 months an interim measure will be conducted with
all the above mentioned primary and secondary outcomes.
Background summary
A healthy mouth at young age translates into better overall health. Severe
early childhood caries reduces the overall health, quality of life and hinders
the overall development. The past 25 years no improvement in children's oral
health has occurred. Although dental caries is relatively easy to prevent,
still nearly 50% of Dutch five-year olds suffer from dental caries. The gap in
health between lower and higher socio-economic classes has increased and
problems with oral health are mainly concentrated in lower socio-economic
classes. Primary dental care for children is insured, though, most children
visit a dental care professional too late. Many children already developed
caries before their first dental visit and in case of severe dental caries,
treatment under general anesthesia is often required. At present, treatment of
dental caries is the largest expense of the insured care for children. Despite
the task to promote oral health and refer to dental practices at well-baby
clinics, focus on this topic is missing. There is a lack of effectstudies on
preventive dental care for preschool children, resulting in the fact that
insurers still clinging to curative fees.
Based on the successful Scotisch Chilsmile program, an oral health coach will
be detached at well-baby clinics in order to improve the task of oral health
promotion. The oral health coach will work according to the NOCTP methodology
which has been proven effective to prevent dental caries in schoolchildren.
The central question in this study: Does the implementation of an oral health
coach at well-baby clinics, working according to the NOCTP methodology and
using the Health Action Process Aproach behavior model, lead to behavior
change in parents, better oral health in preschoolchildren and is it feasible
and cost-effective?
Study objective
The objective of this study is to contribute to evidence based intervention to
optimize dental care for preschool children, and deliver evidence of
feasibility and (cost-)effectiveness of this innovative intervention in which
an oral health coach is integrated in primary health care.
Study design
A randomized controlled trial with blinded outcome measures will be performed,
in which the interventiongroup receive oral health care at well-baby clinics
offered by an oral health coach started from the age of six months (eruption
first primary tooth) up to 72 months (last visit well-baby clinic). The control
group will receive usual care. The research is conducted at five well-baby
clinics in Utrecht, Amsterdam, Culemborg, Den Bosch and Tilburg. Well-baby
clinics selected for this study are located in focus districts which are
populated by predominantly lower socio economic classes.
Intervention
At all well-baby clinics both an intervention as a control group is present.
Children in the control group receive usual care, which consist of limited oral
health promotion by health professional at well-baby clinic and referral to
dental clinic from the age of two year. The intervention group receive oral
health care according to the NOCTP method with a tailored risk based interval
combined with usual visits to the well-baby clinic.
Study burden and risks
There are no risks associated with participation in this study. In the
Netherlands oral health care is insured for al children under 18 years of age.
Care provided by the oral health coach as well as the clinical examinations are
comparable with usual care. Children in the interventiongroup may benefit from
participation due to improvement of oral health. The burden for participating
parents and children is minimal. Visits to the oral health coach are combined
with regular well-baby centre visits. Only when a child is at high risk for
developing dental caries, parents are advised to visit the oral health coach
more often. All children included in this study will have two clinical
examinations at 24 months and 45 months (10-20 minutes per examination). All
parents are asked to complete a questionnaire, baseline, 24 and 45 months
(10-15 minutes per questionnaire). At 72 months, parents will be asked for
another questionnaire and clinical examination.
Heidelberglaan 7
Utrecht 3584 CS
NL
Heidelberglaan 7
Utrecht 3584 CS
NL
Listed location countries
Age
Inclusion criteria
first tooth eruption
Exclusion criteria
Parents/caregivers must be able to perform oral health care in their children
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
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CCMO | NL60021.041.17 |