- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04388098
Oral Health Status of Asthmatic Children
30. juni 2020 oppdatert av: ŞİRİN GÜNER ONUR, Trakya University
Oral Health Status of Asthmatic Children and Adolescents
This study aimed to investigate the dental caries experience, periodontal health and salivary properties of asthmatic and non-asthmatic children ⁄ adolescents.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
A total of 108 children aged from 7 to 16 years old were included in this study and equally divided into two groups: Group I (asthmatic children) and Group II (healthy control).
All the children were clinically examined to assess their dental caries experience and periodontal health condition.
A trained and calibrated examiner (kappa = 0.95) performed the dental caries examination according to World Health Organization (WHO) criteria.
Dental caries status was recorded using the number of decayed, missing or filled teeth (dmft/DMFT) and decayed, missing or filled surface (dmfs/DMFS) indices.
Periodontal health was assessed by gingival index [GI] and plaque index(PI).
An interview was conducted with parents/guardians and a structured questionnaire was employed to parents in addition to medical records.
Stimulated salivary samples were collected and assessed for salivary flow rate, salivary pH and buffering capacity.
Studietype
Observasjonsmessig
Registrering (Faktiske)
108
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
7 år til 16 år (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
A total of 108 children aged from 7 to 16 years old were included in this study and equally divided into two groups: Group I (asthmatic children) and Group II (healthy control).
Beskrivelse
Inclusion Criteria:
- Aged between 7-16
- Asthma diagnosis
- Asthma treatment for at least 1 year
- Under asthma medication
- Healthy controls without any systemic condition
Exclusion Criteria:
- Asthma diagnosis less than a year
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Asthmatic children
Asthmatic children were clinically examined to assess their dental caries experience and periodontal health condition.
Stimulated salivary samples were collected and assessed for salivary flow rate, salivary pH and buffering capacity.
|
|
Non-asthmatic children
Non-asthmatic children were clinically examined to assess their dental caries experience and periodontal health condition.
Stimulated salivary samples were collected and assessed for salivary flow rate, salivary pH and buffering capacity.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Oral health status
Tidsramme: During examination 1 day
|
Caries experience of asthmatic and non-asthmatic children was recorded using the number of decayed, missing or filled teeth (dmft/DMFT) and decayed, missing or filled surface (dmfs/DMFS) indices.
The gingival index (GI) was used to assess the gingival condition according to the criteria of Loe and Silness as follows: no gingival inflammation (<0.1), mild inflammation (0.1-1.0), moderate inflammation (1.1-1.9), and severe inflammation in case of marked gingival redness and edema with spontaneous bleeding and ulceration (2.0-3.0)
Plaque index(PI) was used to assess the amount of dental plaque.The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth: A film of plaque adhering to the free gingival margin and adjacent area of the tooth.
|
During examination 1 day
|
salivary flow rate -Salivary characteristics
Tidsramme: 5 minutes after saliva collection
|
Stimulated salivary samples were collected and assessed for salivary flow rate.
Saliva check buffer kit was used for the measurements according to instructions described on the user guide.
|
5 minutes after saliva collection
|
salivary pH - Salivary characteristics
Tidsramme: 5 minutes after saliva collection
|
Stimulated salivary samples were collected and assessed for salivary pH GC saliva check buffer kit was used for the measurements according to instructions described on the user guide.
|
5 minutes after saliva collection
|
buffering capacity - Salivary characteristics
Tidsramme: 5 minutes after saliva collection
|
Stimulated salivary samples were collected and assessed for buffering capacity.
GC saliva check buffer kit was used for the measurements according to instructions described on the user guide.
|
5 minutes after saliva collection
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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. september 2016
Primær fullføring (Faktiske)
1. mai 2018
Studiet fullført (Faktiske)
1. juni 2019
Datoer for studieregistrering
Først innsendt
11. mai 2020
Først innsendt som oppfylte QC-kriteriene
13. mai 2020
Først lagt ut (Faktiske)
14. mai 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. juli 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. juni 2020
Sist bekreftet
1. juni 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2017/210
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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