- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04122508
Are Dental Neglect and the Siblings Risk Factors in Children
9. oktober 2019 oppdatert av: Sema Aydınoglu, Recep Tayyip Erdogan University Training and Research Hospital
Are Dental Neglect and the Presence of Siblings Risk Factors for Oral Health in Children
Neglect insidiously affects a child's overall health in all aspects.
The aim of this study was to determine whether the presence of siblings caused dental neglect, and whether there was a relationship between dental neglect and anxiety.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
Dental neglect is an intentional failure of parents or caregivers to take precautions and fulfil necessary dental treatment, and has a close relationship with dental caries and anxiety.
Oral health status of the children was evaluated using the DMFT/dmft, PUFA/pufa, and OHI-S indices.
In addition, the parents completed the Dental Neglect Scale (DNS) and a questionnaire, and the Modified Child Dental Anxiety Scale (MCDASf) was administered to the children to assess their dental anxiety.
Studietype
Observasjonsmessig
Registrering (Faktiske)
100
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Rize, Tyrkia, 53100
- Recep Tayyip Erdogan University Training and Research Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
6 år til 12 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
children who presented for the first time to the Faculty of Dentistry in Rize
Beskrivelse
Inclusion Criteria:
- Aged between 6 and 12 years old
- Being healthy
- Being volunteer for the study
Exclusion Criteria:
- Systemic and mental disorders
- Syndromes or other major health diseases
- Cooperation problems
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Crossover
- Tidsperspektiver: Tverrsnitt
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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the effects of presence of siblings on dental neglect
Tidsramme: for eight months from the beginning of the study
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The effects of presence of siblings on oral health and dental neglect was assessed using dental neglect scale.
The dental neglect scale for children was originally composed of seven statements, using a Likert scale ranging from one to five .
The total score of DNS can range from 7 to 35, with higher scores representing greater dental neglect.
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for eight months from the beginning of the study
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the effects of presence of siblings on oral health
Tidsramme: for eight months from the beginning of the study
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the effects of presence of siblings on oral health and dental neglect was assessed using oral hygiene index .
The OHI-S has two elements, the Debris Index and the Calculus Index.
The Debris Index and the Calculus Index can range from 0 to 3, the oral hygiene index values from 0 to 6.
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for eight months from the beginning of the study
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the effects of presence of siblings on dental caries
Tidsramme: for eight months from the beginning of the study
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the effects of presence of siblings on oral health and dental neglect was assessed using, DMFT/dmft index.
caries (D/d), missing due to caries (M/m), filling (F/f) teeth were recorded using DMF-T indices for permanent teeth and dmf-t indices for primary teeth.
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for eight months from the beginning of the study
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the effects of presence of siblings on untreated caries
Tidsramme: for eight months from the beginning of the study
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the effects of presence of siblings on oral health and dental neglect was assessed using pufa index.
The index recorded the presence of visible pulp involvement (P/p), mucosal ulceration due to root fragments (U/u), fistulae (F/f) and/or abscessess (A/a).
Higher scores represents worse oral health.
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for eight months from the beginning of the study
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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to evaluate whether there was a correlation between dental neglect and anxiety in children
Tidsramme: for eight months from the beginning of the study
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the relationship between dental neglect and anxiety was evaluated using Modified Child Dental Anxiety Scale (MCDASf).
MCDASf, which is a validated and reliable indicator for the measurement of dental anxiety in children was used.
Children in this study were asked to complete the MCDASf, which covers eight multiple choice statements with five faces ranging from 1 (not anxious), to 5 (extremely anxious).
The total score on the MCDASf was calculated for each subject (ranging from 5: little or no dental anxiety, to 40: severe dental anxiety.
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for eight months from the beginning of the study
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Sema Aydınoglu, Dr, Recep Tayyip Erdogan University Training and Research Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2019
Primær fullføring (Faktiske)
31. juli 2019
Studiet fullført (Faktiske)
30. september 2019
Datoer for studieregistrering
Først innsendt
5. oktober 2019
Først innsendt som oppfylte QC-kriteriene
9. oktober 2019
Først lagt ut (Faktiske)
10. oktober 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. oktober 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. oktober 2019
Sist bekreftet
1. oktober 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 62
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Ja
IPD-planbeskrivelse
De-identified individual participant data for all primary and secondary outcome measures will be made available.
IPD-delingstidsramme
Data will be available 5 years after publication
Tilgangskriterier for IPD-deling
Data access requests will be reviewed by authors.
IPD-deling Støtteinformasjonstype
- Studieprotokoll
- Statistisk analyseplan (SAP)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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