Prevalence of Chronic Oral Graft Versus Host Disease Risk Factors in Pediatric Patients
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|ClinicalTrials.gov Identifier: NCT03880214|
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 20, 2019
|Condition or disease|
|Oral Disease Graft-versus-host-disease Stem Cell Transplant Complications Pediatric Disorder|
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.
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||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|
|Estimated Study Start Date :||April 2019|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
stem cells transplanted pediatric patients
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
- oral mucosal alterations - Comprehensive intraoral clinical examination for the soft tissue under good lightening condition to detect any abnormalities (yes/no) [ Time Frame: 10 minutes ]
- Comprehensive intraoral clinical examination for the soft tissue under good lightening condition to detect any abnormalities (yes/no) .
- salivary gland function [ Time Frame: 10 minutes ]resting and stimulated saliva flow examination
- sclerotic disease assessed [ Time Frame: 2 minutes ]inter incisional distance
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880214
|Contact: yasmeen magdi sholkamy, BDSfirstname.lastname@example.org|
|Contact: wessam abd el email@example.com|
|Study Chair:||basma abd el alim||Lecturer at Department of Oral Medicine and periodontology Cairo University|