Prevalence of Chronic Oral Graft Versus Host Disease Risk Factors in Pediatric Patients

Study Overview
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Brief Summary
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our aim is estimating the Prevalence and predicting risk factors for developing chronic oral graft versus host disease in pediatric patients subjected to hematopoietic stem cells transplantation

Detailed Description
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The study will be held in Children's Cancer Hospital Egypt for pediatric patients who underwent bone marrow transplantation. this study describes oral conditions, detect possible oral pathological manifestations and evaluate their prevalence as well as correlating it to assumed risk factor as age, sex, type of the transplant , previous acute attack of graft versus host disease and other organ involvement . A standardized Transplant Database Questionnaire will be completed Clinical examination will be performed then findings will be recorded for oral mucosal lesions , salivary flow rate in milliliter , mouth opening in milliimeter. Sample size estimation : The aim of this study is to screen pediatric patients at least three months after they undergo allogeneic hematopoietic stem cells transplantation to detect any risk factors for developing oral manifestations of chronic graft versus host disease during this period. Every patient fulfilling inclusion criteria in the hospital will be recruited consecutively in a period of six months starting from April 2019.

Official Title
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Cross Sectional Study Estimating the Prevalence and Predicting Risk Factors for Developing Chronic Oral Graft Versus Host Disease in Pediatric Patients Subjected to Hematopoietic Stem Cells Transplantation

Conditions
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Oral Disease, Graft-versus-host-disease, Stem Cell Transplant Complications, Pediatric Disorder

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients aged between 3 and 13 who underwent bone marrow transplantation at least 3 months ago. Neoplastic or non- neoplastic diseases. Patient receiving any protocol of GVHD prophylactic treatment. Exclusion Criteria: Patients who do not approve to join the study. Patient receiving chemo or radiotherapy .

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| stem cells transplanted pediatric patients<br>screen pediatric patients at least 3 months after they undergo allogeneic hematopoietic stem cells transplantation to detect any risk factors for developing oral manifestations of chronic graft -versus-host disease during this period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oral mucosal alterations - Comprehensive intraoral clinical examination for the soft tissue under good lightening condition to detect any abnormalities (yes/no) | Clinical examination - Comprehensive intraoral clinical examination for the soft tissue under good lightening condition to detect any abnormalities (yes/no) . | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| salivary gland function | resting and stimulated saliva flow examination | 10 minutes | 
| sclerotic disease assessed | inter incisional distance | 2 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral GVHD, Pediatric