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

29 luglio 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Intervento / Trattamento

Descrizione dettagliata

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)

Tipo di studio

Osservativo

Iscrizione (Anticipato)

150

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 2 anni a 14 anni (Bambino)

Accetta volontari sani

N/A

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Caries
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Enamel hypoplasia
Lasso di tempo: 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
Lasso di tempo: Five minutes
Clinical examination will be conducted to assess oral candidiasis and recorded by use of Lehner Oral Candidiasis Classification
Five minutes
Gingival overgrowth
Lasso di tempo: Five minutes
Clinical examination will be done to asess gingival overgrowth and recorded by use of Angelopoulos and Goaz index
Five minutes

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 novembre 2019

Completamento primario (Anticipato)

1 dicembre 2019

Completamento dello studio (Anticipato)

1 gennaio 2020

Date di iscrizione allo studio

Primo inviato

29 giugno 2018

Primo inviato che soddisfa i criteri di controllo qualità

16 luglio 2018

Primo Inserito (Effettivo)

18 luglio 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

31 luglio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 luglio 2019

Ultimo verificato

1 luglio 2019

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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