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

NCT07179523 | Completed Early Phase 1 DMC

• 1 other identifier: 26522
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ColiSorB

Outcome Measures

Primary Outcomes (2)

• Time to achieve full absorption and hemostasis

  Time (in minutes) from baseline (application of the assigned dressing immediately after tooth extraction) until complete hemostasis is achieved, defined as cessation of visible bleeding at the extraction site.

  Assessed from baseline until hemostasis is achieved (within 1 day).

• Time of placement

  Duration (in minutes) required at baseline to apply the assigned dressing (sponge or standard gauze) at the extraction site, including any pre-wetting step if applicable.

  Assessed at baseline (time of dressing application immediately after tooth extraction).

Secondary Outcomes (1)

• Pain and Healing Scale

  Up to 7 days

Study Arms (3)

Control

NO INTERVENTION

Conventional cotton and gauze were applied with firm pressure on the extraction site

Experimental Comparator Group

ACTIVE COMPARATOR

A commercially available hemostatic sponge was used, namely Cutanplast.

Combination Product: Hemostatic Agent

Experimental Group

EXPERIMENTAL

A newly developed hemostatic gelatin sponge called Colisorb was used

Combination Product: Hemostatic gelatin sponge

Interventions

Hemostatic gelatin sponge COMBINATION_PRODUCT

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.

Experimental Group

Hemostatic Agent COMBINATION_PRODUCT

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.

Also known as: Cutanplast

Experimental Comparator Group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients seeking removal of a wisdom tooth due to:
• Severe decay
• Malposition/misalignment
• Pressure caries affecting adjacent teeth
• Indication for future orthodontic treatment
• Age ≥ 14 years
• Available for at least one postoperative evaluation (scheduled approximately 7 days post-surgery)
• Willing and able to provide informed consent for participation

You may not qualify if:

• Unwillingness to provide informed consent
• Current use of anticoagulant medications (e.g., Aspirin, Coumadin, Plavix) or discontinuation of such medications \< 3 days prior to surgery
• Pregnant, planning pregnancy during the follow-up period, or actively breastfeeding
• Active or suspected infection at the surgical site
• Known sensitivity or allergy to any component of the hemostatic gelatin sponge
• Severe congenital or acquired immunodeficiency
• Undergoing bisphosphonate therapy
• Diabetes with unstable blood glucose levels

Sponsors & Collaborators

• Sara Omar: lead
• Incura Inc.: collaborator

Study Sites (1)

Department of Oral & maxillofacial surgery at Cairo University

Cairo, Giza Governorate, 12613, Egypt

Location

MeSH Terms

Interventions

Hemostasis

Intervention Hierarchy (Ancestors)

Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Researcher

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 18, 2025
• Study Start: September 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)