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Completed

NCT Number: NCT06457360

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

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

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

British University in Egypt

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with end stage liver disease that need dental extraction before liver transplant
  • Patients aged between 4 and 9 years old
  • Patients having international normalized ratio (INR) values ≤ 4 (i.e. 1-4)

Exclusion criteria

  • Patients with allergy to sea food because chitosan- based dressing is manufactured from freeze-dried chitosan, derived from shrimp shell.
  • Patients having genetic bleeding disorders
  • Patients with renal diseases

Treatment and study plan

Tranexamic Acid

Drug

Application of sterile gauze after extraction for hemostasis

Ankaferd Blood Stopper

Drug

Application of sterile gauze after extraction for hemostasis

Chitosan

Drug

Application of sterile gauze after extraction for hemostasis

Primary outcomes

  1. To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases

    Time frame: 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 outcomes

  1. pain score assessment

    Time frame: 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

Sponsors and collaborators

Lead sponsor

British University In Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 13, 2024
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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