Colibricare Efficacy on Oral Surgical Procedures/Extraction Wound and Gingiva Retraction

June 9, 2026 updated by: Nahla Mahmoud Awad, Cairo University

Evaluating the Hemostatic Efficacy and Comparing the Clinical Performance of Colibricare; A Newly Devel-oped Dental Sponges on Oral Surgical Procedures/Extraction Wound and Gingiva Retraction to Other Conven-tional Products (Randomized Clinical Trail)

In this randomized, three-arm trial, 120 patients undergoing wisdoms' extractions were assigned to control (gauze pressure application), commercial sponge, or Coli-sorb® groups. Outcomes included time to hemostasis, ease of placement, pain (VAS), facial swelling, and wound healing, assessed on days 1, 7, and 6 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Colisorb® is a safe, efficient, and biocompatible hemostatic agent, providing rapid bleeding control, reduced pain, and enhanced healing, outperforming conventional gauze and commercial alternatives.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 12515
        • Cario University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • require wisdoms removal

Exclusion Criteria:

  • systemic diseases affecting healing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Colisorb
study arm
Procedure: wisdoms' surgical extractions
surgical removal of wisdoms
Experimental: gelatin sponge
study
Procedure: wisdoms' surgical extractions
surgical removal of wisdoms
Placebo Comparator: gauze pressure
control arm
Procedure: wisdoms' surgical extractions
surgical removal of wisdoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain
Time Frame: 7 days
VAS visual analogue scale grades (0-10)
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
closure of the wound
Time Frame: 15 days
binary method yes or no
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2022

Primary Completion (Actual)

May 26, 2022

Study Completion (Actual)

May 26, 2026

Study Registration Dates

First Submitted

June 5, 2026

First Submitted That Met QC Criteria

June 5, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cario university

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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