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Oral Findings in a Group of Egyptian Pediatric Patients at Endstage Renal Disease

29. juli 2019 oppdatert av: Rahma Ali Saber Ali, Cairo University

Oral Findings in a Group of Egyptian Pediatric Patients at Endstage Renal Disease Either on Haemodialysis or After Renal Transplantation

In Egypt, the prevalence of end stage renal disease in pediatric population has never been estimated on a national scale. The patients at end stage renal disease encounter oral and dental problems that emphasize regular and careful screening . In Egypt, the prevalence of oral findings is not studied so we conduct this study to study the oral findings among a group of pediatric patients at end stage renal disease either on haemodialysis or after kidney transplantation.

Studieoversikt

Status

Ukjent

Intervensjon / Behandling

Detaljert beskrivelse

Study setting:

  • The study will be held at the center of Pediatric Nephrology and transplantation, El- Mounira children's hospital (Abu El rish).
  • The data collected through the questionnaire will be obtained through an interview between the investigator and the parent or the legal guardian that's based on WHO guide for health surveys(WHO Oral health surveys, 2013)
  • For patients undergoing dialysis, examination will be performed at the dialysis unit during dialysis session (there is no waiting room for patients before dialysis).
  • For patients who received renal transplantation, examination will be performed at the outpatient nephrology clinic during follow up visits.
  • Clinical examination will be performed for both oral (soft tissue) and dental (hard) tissue.
  • Decayed-Missing-Filled Index ( DMF ) which was introduced by Klein, Palmer and Knutson in 1938 and modified by WHO.

The components are:

D component:

Used to describe (Decayed teeth) which include:

Carious tooth. Filled tooth with recurrent decay. Only the roots are left. Defect filling with caries. Temporary filling. Filled tooth surface with other surface decayed.

M component:

Used to describe (Missing teeth due to caries) other cases should be excluded.

F component:

Used to describe (Filled teeth due to caries). Teeth were considered filled without decay when one or more permanent restorations were present and there was no secondary (recurrent) caries or other area of the tooth with primary caries. A tooth with a crown placed because of previous decay was recorded in this category. Teeth stored for reason other than dental caries should be excluded.

deft / defs , which was introduced by Gruebbel in 1944

d- decayed tooth . e- decayed tooth indicated for extraction . f- filled tooth

• The coding system for the Modified DDE Index has three items of information that will be recorded for each tooth surface. (Clarkson and O'Mullane, 1989)

First, the Type of Defect, codes 0-7, was recorded. Then the Sub-type of that defect was noted, i.e., when a demarcated opacity was present, the Sub-type was either white/cream (code 1) or yellow/brown (code 2), or when a diffuse opacity was present, then six options were possible. Finally, the extent of each defect was recorded. The new additional sub-type (code 3) termed "diffuse confluent opacity" is defined as a diffuse opacity in which any patchiness has merged into a regular condensed chalky white area, and it could cover the entire surface of a tooth or be confined to a localized area of the tooth surface.

  • Oral candidiasis assessment will be based on the Lehner scale (Cleverson et al., 2014)
  • In assessing the degree of gingival hyperplasia we will use the index of Angelopoulos and Goaz, described by Prof. T. Djemileva. (Dencheva et al., 2011)

Studietype

Observasjonsmessig

Registrering (Forventet)

150

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

2 år til 14 år (Barn)

Tar imot friske frivillige

N/A

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

All pediatric patients at end stage renal disease attending at the center of Pediatric Nephrology and transplantation, El- Mounira children's hospital (Abu El rish) will be enrolled in the study in a consecutive order according to inclusion criteria.

Beskrivelse

Inclusion Criteria:

  1. Pediatric patients <15 years old with a diagnosis of end stage renal disease "stage 5" receiving dialysis.
  2. Pediatric Patients < 15 years old with kidney transplantation in the monthly follow up.
  3. Recorded data for every patient. (Glomerular Filtration Rate, Creatinine level, urea level and calcium level).

Exclusion Criteria:

  1. Patients undergoing renal dialysis for reasons other than chronic kidney disease, such as acute renal failure secondary to accidents, trauma, snake poisoning.
  2. Patients undergoing peritoneal dialysis.
  3. Patients not physically able to participate in the examination.
  4. Chronic kidney disease patients at stage 2, 3 and 4.

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
Heamodialysis group
The data will be collected through a questionnaire that will be obtained through an interview between the investigator and the parent or the legal guardian
Kidney transplantation group
The data will be collected through a questionnaire that will be obtained through an interview between the investigator and the parent or the legal guardian

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Caries
Tidsramme: Five minutes
Clinical examination will be done and Caries index will be used ,Unit is the tooth to determine if there is caries or not
Five minutes

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Enamel hypoplasia
Tidsramme: Ten minutes
Clinical examination will be done on each patient to assess enamel hypoplasia and recorded by use of Modified Developmental Defect of Enamel (DDE) Index
Ten minutes
Oral candidiasis
Tidsramme: Five minutes
Clinical examination will be conducted to assess oral candidiasis and recorded by use of Lehner Oral Candidiasis Classification
Five minutes
Gingival overgrowth
Tidsramme: Five minutes
Clinical examination will be done to asess gingival overgrowth and recorded by use of Angelopoulos and Goaz index
Five minutes

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

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. november 2019

Primær fullføring (Forventet)

1. desember 2019

Studiet fullført (Forventet)

1. januar 2020

Datoer for studieregistrering

Først innsendt

29. juni 2018

Først innsendt som oppfylte QC-kriteriene

16. juli 2018

Først lagt ut (Faktiske)

18. juli 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. juli 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. juli 2019

Sist bekreftet

1. juli 2019

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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