- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04861675
Assessment of Changes in Oral Health-related Quality of Life , Oral Hygiene Status and Body Growth in CSHCN Following Dental Treatment Under General Anaesthesia
26. april 2021 oppdatert av: Mahy Abdel Raouf Aly Kamar, Cairo University
Assessment of Changes in Oral Health-related Quality of Life , Oral Hygiene Status and Body Growth in Egyptian Children With Special Health Care Needs Following Dental Treatment Under General Anaesthesia
evaluation of the impact of dental treatment under GA on oral health-related quality of life (OHRQoL) in children with SHCN with severe dental caries with Assessment in change in oral health status and the impact on children's weight (Wt), height (Ht), Body Mass Index (BMI).
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
The study consisted of clinical dental examinations performed at the time of DGA and at the six-month recall, along with OHRQoL questionnaires and data drawn from the patients' files.
- OHRQoL will be assessed with the early childhood oral health impact scale (ECHOIS) that is composed of items which assess the effect of oral health condition on different aspects of life of the patient .
- Children with Mental special health care needs will be recruited from G.A unit in department of pediatric dentistry , faculty of oral and dental medicine cairo university.
- Data will be collected for each of the study participants included age, gender ,Medical (type of disability and history of disability) , dental histories and clinical findings were correlated accordingly together with determining the type of disability, anthropometric measures (HT, WT,BMI) that will be measured at baseline and after 3 to 6 months from dental treatment under general anesthesia.
- The parent or the care giver will be taken as a surrogate measure that will self-complete (ECOHIS) Before and after treatment with follow up after 3 & 6 months to assess and evaluate children's OHRQoL and anthropometric measures update.
- Each GA session included a comprehensive clinical dental examination and full dental rehabilitation. The Silness-Loe plaque index (PI) was used to assess oral hygiene status. That was measured in the four levels of distal facial, mesial-facial, facial, and lingual of first molars, first premolar and central in each quadrant using mirror and probe.
- The plaque index was obtained by adding the figures of the four above-mentioned areas of each teeth and dividing it by 4 before recording it in the examination form
- Parents/ caregiver will be asked to consider the last 6 months when responding the questions After ttt , Examine effect of oral rehabilitation under GA and its effect on improving quality of life ( pain , eating problems, sleeping problems ,growth parameters as (Wt, Ht, BMI) and any postoperative complications as postoperative pain and pharynx discomfort or fever
Studietype
Observasjonsmessig
Registrering (Forventet)
10
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
3 år til 9 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Children with Mental special health care needs undergoing oral rehabilitation under general anaesthesia.
Beskrivelse
Inclusion Criteria:
- Intellectual disabled children with carious teeth
Exclusion Criteria:
- Healthy children
- children with physical special needs.
- Refusal of participation.
- Participation in any other concurrent clinical trials.
- Presence of any serious medical condition or transmissible diseases such as hepatitis , AIDS or malignancies.
- Children whose parents refuse to sign the consent or have no phone no. to enable post-operative contact.
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 |
|---|---|
|
Prospective follow up cohort study
Assessment of Changes in Oral Health-related Quality of Life , Oral Hygiene status and Body Growth in Egyptian Children with Special Health Care Needs following Dental Treatment under General Anaesthesia
|
Assessment of change in oral health related quality of life , body growth status and oral hygiene status for children with special health care needs after full mouth rehabilitation under general anesethia,
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in oral health related quality of life.
Tidsramme: 6 months
|
Early childhood oral health impact scale , A total score of ECOHIS ranging from 0 to 52 was calculated as a simple sum of the responses.
Higher scores representing a greater oral health impact and/or poorer OHRQoL.
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Oral hygiene status
Tidsramme: 6 months
|
Plaquei ndex (Löe and Silness, 1963)
|
6 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Body mass index
Tidsramme: 6 months
|
weight and height will be combined to report BMI in kg/m^2
|
6 months
|
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 (Forventet)
1. juli 2021
Primær fullføring (Forventet)
1. januar 2022
Studiet fullført (Forventet)
1. juli 2022
Datoer for studieregistrering
Først innsendt
22. april 2021
Først innsendt som oppfylte QC-kriteriene
26. april 2021
Først lagt ut (Faktiske)
27. april 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. april 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. april 2021
Sist bekreftet
1. april 2021
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 14422019465983
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .