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

October 16, 2024 updated by: British University In Egypt

Comparative Assessment of Chitosan-Based Dressing, Ankaferd and Tranexamic Acid in Achieving Hemostasis and Healing Following 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • British University In Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1 sterile gauze with chitosan
Chitosan-based dressing gauze after extraction in patients with end stage liver disease
Drug: Chitosan
Application of sterile gauze after extraction for hemostasis
Experimental: group 2 sterile gauze with ankaferd blood stopper
ankaferd blood stopper dressing gauze after extraction in patients with end stage liver disease
Drug: Ankaferd Blood Stopper
Application of sterile gauze after extraction for hemostasis
Active Comparator: group 3 sterile gauze with tranexamic acid
tranexamic acid dressing gauze after extraction in patients with end stage liver disease
Drug: tranexamic acid
Application of sterile gauze after extraction for hemostasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British University In Egypt

Investigators

  • Principal Investigator: noha S Kabil, British University In Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Actual)

January 20, 2024

Study Completion (Actual)

May 20, 2024

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

June 9, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

October 18, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PED 20-2D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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