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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06457360
Enrollment
39
Registered
2024-06-13
Start date
2023-11-15
Completion date
2024-05-20
Last updated
2024-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis

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

Interventions

DRUGtranexamic acid

Application of sterile gauze after extraction for hemostasis

DRUGAnkaferd Blood Stopper

Application of sterile gauze after extraction for hemostasis

DRUGChitosan

Application of sterile gauze after extraction for hemostasis

Sponsors

British University In Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
4 Years to 9 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To assess the hemostatic effect of chitosan-based dressing, Ankaferd and Tranexamic acid after extraction in children with end stage liver diseases30 minutesevaluation 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

MeasureTime frameDescription
pain score assessment7 daysPain 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026