- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03432728
Salivary Antioxidant Capacity Before and After Complete Dental Rehabilitation
Salivary Antioxidant Capacity of Children With Severe Early Childhood Caries (S-ECC) Before and After Complete Dental Rehabilitation
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Background: The association of total salivary antioxidant capacity (TAC) to severe early childhood caries (S-ECC) has been studied in the past. It is not clear if TAC is an indicator of the inflammatory response to the lesion or a marker of the disease.
Aim: This study aimed to measure the salivary TAC levels in children with early childhood caries before and after dental treatment and compare the results to caries free children.
Methodology: Salivary samples were obtained from 20 children in their fifth year of life diagnosed S-ECC and 20 age and gendersex matched controls. Complete dental rehabilitation under general anesthesia was performed for the 20 children with S-ECC, and follow up salivary samples were obtained one week and three months post operatively. The TAC was measured using a commercially available Oxygen Radical Absorbance Antioxidant Assay measurement kit (Zen-Bio ORAC™, AMS Biotechnology, Abington UK).
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Riyadh, Saudi-Arabia
- Riyadh Colleges of Dentistry and Pharmacy
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
- Children who are on long term medications,
- Children with chronic diseases
- Children who have had an infection less than three weeks prior to collection of saliva
Beskrivelse
Inclusion Criteria:
- Medically fit children
- Age below 71 months
- Test group - to be diagnosed with severe ECC
- Control group - to be caries free
Exclusion Criteria:
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
S-ECC
Children in their fifth year of life with severe early childhood caries Children selected will require complete dental rehabilitation under general anesthesia All enrolled children will receive treatment of all dental carious lesions under general anesthesia
|
Dental treatment of all teeth affected by dental caries in a single visit under general anesthesia
|
|
Control
Children age and sex matched with the S-ECC group who are free of dental caries
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in TAC after one week
Tidsramme: One week
|
Change in Total Salivary Antioxidant Capacity of children from baseline to one week after treatment
|
One week
|
|
Change in TAC after Three months
Tidsramme: Three months
|
Change in Total Salivary Antioxidant Capacity of children from baseline to three months after treatment
|
Three months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Sharat C Pani, MDS, Riyadh Colleges of Dentistry and Pharmacy
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FPGRP/ /43435005/126
Plan for individuelle deltakerdata (IPD)
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