PREP-cariesrisk-study;Prevalence of vitamin D deficiency, enamel composition and associations with dental demineralisations in high caries-risk children treated under ambulatory anesthesia

Completed

Conditions: caries
dental decay

Registration Number: NL-OMON45730

Lead Sponsor: Meander Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 250

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameters/outcome of the study: primarily the study will focus<br /><br>on the caries score and hypomineralisations. The caries status is done with the<br /><br>ICDAS score, a Likert type score with clinical endpoints (Healthy: ICDAS 0;<br /><br>Initial lesion: ICDAS 1 or2; Medium lesion: ICDAS 3 OR 4; Serious lesion: ICDAS<br /><br>5 or 6). Also the total number of decayed teeth is assessed using the dmf-t<br /><br>score. Using ICDAS a validated oral health outcome is assessed. Separately<br /><br>enamel disturbances are scored on a scoring list (Elfrink et. al. 2010) to<br /><br>support further research on hypomineralisations in deciduous teeth (Ghanim et<br /><br>al 2015).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/outcome of the study (if applicable): Mainly health<br /><br>related variables related to environmental variables and vitamin D.<br /><br>Questionnaires will provide information on date of birth, sex, parental<br /><br>education, housing and schooltype just as data on sun exposure, vitamin D<br /><br>intake (in foods and supplementation), food pattern. Correlations between all<br /><br>possible caries and health variables will be calculated whenever possible.</p><br>