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

Early Phase 1CompletedNCT06457360

British University In Egypt39 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Liver Cirrhosis

Interventions

tranexamic acidDRUG

Application of sterile gauze after extraction for hemostasis

Ankaferd Blood StopperDRUG

Application of sterile gauze after extraction for hemostasis

ChitosanDRUG

Application of sterile gauze after extraction for hemostasis

Eligibility

Sex: ALLMin age: 4 YearsMax age: 9 Years

Medical Language ↔ Plain English

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

Locations (1)

British University in Egypt

Cairo, Egypt

Outcomes

Primary Outcomes

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

Time frame: 30 minutes

Secondary Outcomes

pain score assessment

Pain scores will be assessed using Visual Analog Scale from 0 to 10 pain score for seven days following extraction where 0 is no pain and 10 is maximum pain

Time frame: 7 days

Data from ClinicalTrials.gov

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