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

Early Phase 1

Completed

• Conditions: Liver Cirrhosis
• Interventions: Drug: Chitosan; Drug: Ankaferd Blood Stopper; Drug: tranexamic acid

• Registration Number: NCT06457360
• Lead Sponsor: British University In Egypt

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-15
• Study First Submitted: 2023-11-22
• Primary Completion: 2024-01-20
• Study Completion: 2024-05-20
• Study First Submitted QC: 2024-06-09
• Study First Posted: 2024-06-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
group 1 sterile gauze with chitosan	Chitosan	Chitosan-based dressing gauze after extraction in patients with end stage liver disease
group 2 sterile gauze with ankaferd blood stopper	Ankaferd Blood Stopper	ankaferd blood stopper dressing gauze after extraction in patients with end stage liver disease
group 3 sterile gauze with tranexamic acid	tranexamic acid	tranexamic acid dressing gauze after extraction in patients with end stage liver disease

Primary Outcome Measures

Name	Time	Method
To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases	30 minutes	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

Secondary Outcome Measures

Name	Time	Method
pain score assessment	7 days	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

Trial Locations

Locations (1)

British University in Egypt; 🇪🇬 Cairo, Egypt