Status:
COMPLETED
Clinical Evaluation of the Effectiveness of Biomimetic Hemostatic Sponges ColiSorB Following Dental Extraction
Lead Sponsor:
Sara Omar
Collaborating Sponsors:
Incura Inc.
Conditions:
Molar Extraction Socket
Eligibility:
All Genders
14+ years
Phase:
EARLY_PHASE1
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 qualifi...
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 o...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07179523
Start Date
September 1 2023
End Date
October 1 2023
Last Update
September 25 2025
Active Locations (1)
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1
Department of Oral & maxillofacial surgery at Cairo University
Cairo, Giza Governorate, Egypt, 12613