The aim of this study is to assess the vitamin D (25(OH)D3) level in 3 and 4 years old high caries risk children. These children are referred to Dutch secondary dental care clinics for restorative treatment. Subject will be selected from children…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
caries
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters/outcome of the study: primarily the study will focus
on the caries score and hypomineralisations. The caries status is done with the
ICDAS score, a Likert type score with clinical endpoints (Healthy: ICDAS 0;
Initial lesion: ICDAS 1 or2; Medium lesion: ICDAS 3 OR 4; Serious lesion: ICDAS
5 or 6). Also the total number of decayed teeth is assessed using the dmf-t
score. Using ICDAS a validated oral health outcome is assessed. Separately
enamel disturbances are scored on a scoring list (Elfrink et. al. 2010) to
support further research on hypomineralisations in deciduous teeth (Ghanim et
al 2015).
Secondary outcome
Secondary study parameters/outcome of the study (if applicable): Mainly health
related variables related to environmental variables and vitamin D.
Questionnaires will provide information on date of birth, sex, parental
education, housing and schooltype just as data on sun exposure, vitamin D
intake (in foods and supplementation), food pattern. Correlations between all
possible caries and health variables will be calculated whenever possible.
Background summary
In 2009 the Dutch research institute TNO stressed the importance of a large
study on the vitamin D status of young children since this might be a possibly
underestimated problem. Recent dental literature came up with clear indications
that a child*s vitamin D status can be a determinant in the child*s caries
risk. When and if this might indicate that vitamin D suppletion next to oral
hygiene instructions and supervising a toothfriendly diet might be beneficial
for improving a child*s oral health, this can be an important point of
attention in the near future.
Study objective
The aim of this study is to assess the vitamin D (25(OH)D3) level in 3 and 4
years old high caries risk children. These children are referred to Dutch
secondary dental care clinics for restorative treatment. Subject will be
selected from children that are treated in full anesthesia (convenience
sample). The results of this study will improve the knowledge on the relation
between the severity of dental decal and the prevalence of vitamin D deficiency
in children. Health support and information on dental decay can be combined
with general health information. Moreover correlations can be studied on the
relation between vitamin D status on one hand and sun exposure, skin
pigmentation, feeding patterns and vitamin D suppletion on the other. This
study can focus on the vitamin D status of high caries risk toddlers and can be
the starting point of a new focus on preventive dental health education.
Study design
This study has a crossectional observational design. It is based on health
questionnaires, filled out by the parents and a detailed caries assessment by
the operating dentist. Also, during the full anesthesia treatment (see aim) a
few drops of blood will be drawn with a fingerstick to assess the vitamin D
blood level. Measurements will take place in the period march/april and
september/oktober 2017. In this period approx. 320 children will be treated in
full anesthesia in the related secondary dental care clinics.
Study burden and risks
None other than the treatment routine.
Maatweg 3
Amersfoort 3813TZ
NL
Maatweg 3
Amersfoort 3813TZ
NL
Listed location countries
Age
Inclusion criteria
Age: children of 3 and 4 years
Sample from patients of the participating secondary dental care practices
See protocol page 18.
Exclusion criteria
Malabsorption because of celiac disease, cystic fibrosis or inflammatory bowel diseases
Chronic liver or renal diseases
Use of medication influencing the vitamin D metabolism such as oral glucocorticosteroids (prenison tablets) and anticonvulsants
Contra-indication for blood sampling such as known coagulation disorder
Reduced immune status, HIV/AIDS/TBC
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 |
|---|---|
| CCMO | NL59723.100.16 |