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

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 1, 2023

Primary Completion Date

October 1, 2023

Study Completion Date

October 1, 2023

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."

Trial Locations (1)

12613

Department of Oral & maxillofacial surgery at Cairo University, Cairo

All Listed Sponsors
collaborator

Incura Inc.

OTHER

lead

Sara Omar

OTHER

NCT07179523 - Clinical Evaluation of the Effectiveness of Biomimetic Hemostatic Sponges ColiSorB Following Dental Extraction | Biotech Hunter | Biotech Hunter