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

• Conditions: Pediatric Disorder; Oral Disease; Stem Cell Transplant Complications; Graft-versus-host-disease

• Registration Number: NCT03880214
• Lead Sponsor: yasmeen magdi sholkamy

Brief Summary

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

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 Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-15
• Study First Posted: 2019-03-19
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-20
• Study Start: 2019-04
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Pediatric patients aged between 3 and 13 who underwent bone marrow transplantation at least 3 months ago.
2. Neoplastic or non- neoplastic diseases.
3. Patient receiving any protocol of GVHD prophylactic treatment.

Exclusion Criteria

1. Patients who do not approve to join the study.
2. Patient receiving chemo or radiotherapy .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
oral mucosal alterations - Comprehensive intraoral clinical examination for the soft tissue under good lightening condition to detect any abnormalities (yes/no)	10 minutes	Clinical examination; - Comprehensive intraoral clinical examination for the soft tissue under good lightening condition to detect any abnormalities (yes/no) .

Secondary Outcome Measures

Name	Time	Method
salivary gland function	10 minutes	resting and stimulated saliva flow examination
sclerotic disease assessed	2 minutes	inter incisional distance