- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03590067
Oral Findings in a Group of Egyptian Pediatric Patients at Endstage Renal Disease
Oral Findings in a Group of Egyptian Pediatric Patients at Endstage Renal Disease Either on Haemodialysis or After Renal Transplantation
Visão geral do estudo
Descrição detalhada
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 de estudo
Inscrição (Antecipado)
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Pediatric patients <15 years old with a diagnosis of end stage renal disease "stage 5" receiving dialysis.
- Pediatric Patients < 15 years old with kidney transplantation in the monthly follow up.
- Recorded data for every patient. (Glomerular Filtration Rate, Creatinine level, urea level and calcium level).
Exclusion Criteria:
- Patients undergoing renal dialysis for reasons other than chronic kidney disease, such as acute renal failure secondary to accidents, trauma, snake poisoning.
- Patients undergoing peritoneal dialysis.
- Patients not physically able to participate in the examination.
- Chronic kidney disease patients at stage 2, 3 and 4.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Caries
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Enamel hypoplasia
Prazo: 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
Prazo: Five minutes
|
Clinical examination will be conducted to assess oral candidiasis and recorded by use of Lehner Oral Candidiasis Classification
|
Five minutes
|
Gingival overgrowth
Prazo: Five minutes
|
Clinical examination will be done to asess gingival overgrowth and recorded by use of Angelopoulos and Goaz index
|
Five minutes
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Antecipado)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CEBD-CU-2018-06-26
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .