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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03880214

Enrollment

250

Registered

2019-03-19

Start date

2019-04-30

Completion date

2019-10-31

Last updated

2019-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

oral GVHD, Pediatric

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.

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

3 Years to 13 Years

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 .

Design outcomes

Primary

Measure	Time frame	Description
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

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

Contacts

Primary Contactyasmeen magdi sholkamy, BDS

yasmeen_sholkamy17@yahoo.com01069144373

Backup Contactwessam abd el moneim

wesammhs@yahoo.com01207033303

Outcome results