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

NCT ID: NCT07179523

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2023-10-01

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.

Detailed Description

ColiSorB® is a novel biomimetic adhesive, coagulant-free hemostatic sponge engineered for dental and surgical applications. Unlike conventional hemostatic methods that rely on mechanical compression or exogenous coagulation agents, ColiSorB® mimics the body's natural adhesive and clot-stabilization mechanisms. Its architecture replicates the fibrin mesh, forming a bio-adhesive matrix at the application site to achieve rapid hemostasis, minimize patient discomfort, and reduce postoperative complications such as persistent bleeding and alveolar osteitis (dry socket).

The material is composed of a gelatin-based, non-pyrogenic, absorbable polysaccharide that is both cost-effective and adaptable. By eliminating the need for coagulants, ColiSorB® offers a simplified, biocompatible approach to bleeding control in dental extractions.

This study aimed to evaluate the safety and effectiveness of ColiSorB® sponges in patients undergoing molar extraction, with direct comparison to both a widely used commercial reference product (Cutanplast®) and the conventional method of gauze or cotton under pressure. The primary endpoint was the achievement of post-extraction hemostasis, while secondary endpoints included assessment of postoperative pain and wound healing.

Study Groups

Participants were randomized into three equal groups (n = 10 per arm):

1. Test group: ColiSorB® hemostatic sponge.

2. Comparator group: Cutanplast®, a commercially available gelatin-based hemostatic product.

3. Control group: Conventional method using sterile gauze under biting pressure.

A total of 30 extraction sites were evaluated, with each group receiving its designated hemostatic intervention immediately following extraction.

Application and Assessments

• Hemostatic efficacy: Time to complete hemostasis was recorded, with success rates measured at 3 and 10 minutes.
• Bleeding assessment: Bleeding severity was scored using a visual analogue scale (VAS).
• Safety outcomes: Postoperative complications (e.g., infection, dry socket, persistent bleeding), periodontal integrity, and radiographic findings were monitored on postoperative days 1 and 7.
• Pain outcomes: Postoperative pain was evaluated using VAS scores at days 1 and 7.

The study protocol was approved by the Research Ethics Committee, and informed consent was obtained from all participants.

Conditions

Molar Extraction Socket

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental Comparator Group

A commercially available hemostatic sponge was used, namely Cutanplast.

Group Type: ACTIVE_COMPARATOR

Hemostatic Agent

Intervention Type: 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.

Experimental Group

A newly developed hemostatic gelatin sponge called Colisorb was used

Group Type: EXPERIMENTAL

Hemostatic gelatin sponge

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Cutanplast

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incura Inc.

OTHER

Sponsor Role: collaborator

Sara Omar

OTHER

Sponsor Role: lead

Responsible Party

Sara Omar

Clinical Researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Oral & maxillofacial surgery at Cairo University

Cairo, Giza Governorate, Egypt

Countries

Egypt

Other Identifiers

26522

Identifier Type: -

Identifier Source: org_study_id