Early Diagnosis of Leukemic Children Patients Based on Clinical, Age Estimation and Radiographical Evaluation of Oral Affection

Leukemia Clinical Trial

Official title:

Early Diagnosis of Leukemic Children Patients Based on Clinical, Age Estimation and Radiographical Evaluation of Oral Affection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04756258
• Other study ID #: 222
• Status: Completed
• Start date: January 30, 2020
• Est. completion date: October 22, 2020

Study information

• Verified date: February 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Early diagnosis of leukemia which is malignant tumor affecting bone especially in children is import to allow early intervention improving prognosis. It is known that leukemic patients suffer from clinical signs as anemia, thrombocytopenia, and pronounced hepatosplenomegaly or lymphadenopathy. However, sometimes these clinical signs may be not clearly manifested and may look like anemia. The early diagnosis could be achieved through dentist by accessing clinical and radiographical signs such as oral masses, gingival bleeding /or enlargement and oral ulceration with radiographical features including focal or generalized osteolysis of bone with presence of moth eating appearance and even with abnormal teeth chronology regarding teeth morphology, germ formation of permanent teeth and their sequence of eruption. Therefore, accessing of these special clinical and radiographical features by the dentist could help in early diagnosis of leukemic children patients

Description:

Ten children patients suffer from leukemia selected after initial diagnosis from hematology unit of faculty of medicine, Tanta university based on their clinical signs such as; bone pain, fatigability, lymph node enlargement…etc., with abnormal CBC revealing anemia or abnormal WBCs. These patients accessed clinically for oral signs and accessed radiographically using panoramic radiographs and cone beam computed tomography (CBCT) to evaluate chronology and bone density.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 22, 2020
• Est. primary completion date: October 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

Inclusion Criteria:

1-Children will be aged from 6-10 years 2 Children diagnosed with leukemia but they don't start treatment yet -

Exclusion Criteria:

1. Children below or above the age

2. Children already diagnosed by leukemia and started treatment

3. Children diagnosed by other bone lesions showing osteolytic bone or anemia as thalassemia or sickle cell anemia or any other bone pathology

Related Conditions & MeSH terms

• Leukemia

Locations

Country	Name	City	State
Egypt	Rehab Fouad Ghouraba	Tanta	Grabia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to diagnose leukemic child patients who don't have manifesting systemic clinical signs from their clinical and radiographical oral signs	theses leukemic child patients could be diagnosed based on observation of oral signs such as oral masse, ulcers lake normal red hallow, bone loss around teeth without presence of local factors, abnormal teeth chronology regarding teeth morphology and eruption, germ formation of permanent teeth and their sequence of eruption and abnormal bone density through panoramic and CBCT images	one year