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Clinical Evaluation of the Effectiveness of Biomimetic Hemostatic Sponges ColiSorB Following Dental Extraction

NCT07179523 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-25

No results posted yet for this study

Summary

This study tested three different treatment groups in a fair and organized way. It included people who came to Cairo University's Dental Department to have a back tooth (molar) removed and who qualified to join.

Out of 40 people who were checked, 8 did not meet the requirements, and 2 others did not return for check-up visits.

The study followed all ethical rules and was approved by the Research Ethics Committee at Cairo University's Faculty of Oral and Dental Medicine.

Conditions

  • Molar Extraction Socket

Interventions

COMBINATION_PRODUCT

Hemostatic gelatin sponge

Colisorb® exhibits optimal pore structure, number and size, which results in its structure being highly porous with low density. In addition, Colisorb® possesses optimal mechanical integrity allowing it to swell to its maximal absorption capacity while maintaining mechanical stability. The sponge can absorb fluids in the blood resulting in prompt recruitment of clotting factors, hence accelerating the body's natural blood clotting cascade. Colisorb® was configured in a way to imitate natural adhesive mechanism without the use of co-agulants, it provides a safer and a more efficient alternative for minimizing post-operative complications and enhancing recovery. Upon performing the tooth extraction, oral surgeon instantly applied the sponge. Patients were prescribed, antibiotics, and antacid, if needed, for 3 days and analgesics for 5 days, followed by a mouth wash routine of warm water with salt to enhance healing outcomes. Patients visited the clinic three days after surgery.

COMBINATION_PRODUCT

Hemostatic Agent

Gelatin sponge that may be soaked with sterile physiological solution. Biocompatible and easy to use for 5 to 10 minute bleeding control rate. Upon performing the tooth extraction, oral surgeon instantly applied the sponge in the socket where the tooth was extracted to facilitate hemostasis. Patients were prescribed, antibiotics, and antacid, if needed, for 3 days and analgesics for 5 days, followed by a mouth wash routine of warm water with salt to enhance healing outcomes. Patients visited the clinic three days after surgery.

Sponsors & Collaborators

  • Incura Inc.

    collaborator OTHER

  • Sara Omar

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2023-10-01
Completion
2023-10-01

Countries

  • Egypt

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07179523 on ClinicalTrials.gov