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

Sara Omar

Status and phase: Completed; Early Phase 1

Conditions: Molar Extraction Socket

Treatments: Combination Product: Hemostatic gelatin sponge; Combination Product: Hemostatic Agent

Study type: Interventional

Funder types: Other

Identifiers

NCT07179523

26522

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Control

No Intervention group

Description:

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

Experimental Comparator Group

Active Comparator group

Description:

A commercially available hemostatic sponge was used, namely Cutanplast.

Treatment:

Combination Product: Hemostatic Agent

Experimental Group

Experimental group

Description:

A newly developed hemostatic gelatin sponge called Colisorb was used

Treatment:

Combination Product: Hemostatic gelatin sponge