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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45730

Enrollment

250

Registered

2017-08-07

Start date

2017-08-30

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

caries caries dental decay

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results