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NCT06457360 Clinical Trial

Comparison of Chitosan, Ankaferd and Tranexamic Acid in Dental Extraction in Liver Pre-Transplant Children

Liver Cirrhosis Clinical Trial

Official title:
Comparative Assessment of Chitosan-Based Dressing, Ankaferd and Tranexamic Acid in Achieving Hemostasis and Healing Following Dental Extraction in Liver Pre-Transplant Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06457360
Other study ID # PED 20-2D
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date November 15, 2023
Est. completion date May 20, 2024

Study information
Verified date March 2024
Source British University In Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the present study is: To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases where the: • Primary objective: is to evaluate which of the previous materials will be the most effective as a hemostatic agent

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date May 20, 2024
Est. primary completion date January 20, 2024
Accepts healthy volunteers No
Gender All
Age group 4 Years to 9 Years
Eligibility Inclusion Criteria: 1. Patients with end stage liver disease that need dental extraction before liver transplant 2. Patients aged between 4 and 9 years old 3. Patients having international normalized ratio (INR) values = 4 (i.e. 1-4) Exclusion Criteria: 1. Patients with allergy to sea food because chitosan- based dressing is manufactured from freeze-dried chitosan, derived from shrimp shell. 2. Patients having genetic bleeding disorders 3. Patients with renal diseases

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• tranexamic acid
Application of sterile gauze after extraction for hemostasis
• Ankaferd Blood Stopper
Application of sterile gauze after extraction for hemostasis
• Chitosan
Application of sterile gauze after extraction for hemostasis

Locations
Country Name City State
Egypt British University in Egypt Cairo

Sponsors (1)
Lead Sponsor Collaborator
British University In Egypt

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases evaluation of the previous materials which will be the most effective as a hemostatic agent by measuring blood loss after dental extraction after 30 minutes by the weight difference between the gauze preoperatively and postoperatively using fine electronic measurement weight device 30 minutes
Secondary pain score assessment Pain scores will be assessed using Visual Analog Scale (VAS) from 0 to 10 pain score for seven days following extraction 7 days
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