BleedingNCT07638930
Colibricare Efficacy on Oral Surgical Procedures/Extraction Wound and Gingiva Retraction
A study testing wisdoms' surgical extractions in people with Bleeding and Pain, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- What is being tested?
- wisdoms' surgical extractions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteEgypt
- Study dates
- 26 May 2022to 26 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- require wisdoms removal
Who cannot join
- systemic diseases affecting healing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- wisdoms' surgical extractions
- Keywords
- gelatin sponge, surgical tooth extraction;, hemostasis, pain, randomized clinical trial.
- Medical subject headings
- Hemorrhage, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wisdoms' surgical extractionsProcedure or surgery
surgical removal of wisdoms
| Study group | Role | What they receive |
|---|---|---|
| Colisorb | Experimental | study arm Receives: Procedure: wisdoms' surgical extractions |
| gelatin sponge | Experimental | study Receives: Procedure: wisdoms' surgical extractions |
| gauze pressure | Placebo comparator | control arm Receives: Procedure: wisdoms' surgical extractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
VAS visual analogue scale grades (0-10)
Measured: 7 days
Secondary outcomes (1)
closure of the wound
binary method yes or no
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start26 May 2022
- Primary completion26 May 2022
- Study completion26 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 arm clinical trail
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahla Mahmoud Awad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638930
- Sponsor's protocol ID
- cario university
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07638930
- Acronym / sponsor ID
- cario university
- Keywords
- gelatin sponge, surgical tooth extraction;, hemostasis, pain, randomized clinical trial.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 26 May 2022 (actual)
- Primary completion
- 26 May 2022 (actual)
- Study completion
- 26 May 2026 (actual)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3 arm clinical trail
| Arm | Type | Receives |
|---|---|---|
| Colisorb | Experimental | Procedure: wisdoms' surgical extractionsstudy arm |
| gelatin sponge | Experimental | Procedure: wisdoms' surgical extractionsstudy |
| gauze pressure | Placebo comparator | Procedure: wisdoms' surgical extractionscontrol arm |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- require wisdoms removal
Key exclusion criteria (1 listed)
- systemic diseases affecting healing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wisdoms' surgical extractionssurgical removal of wisdoms | Procedure or surgery | Colisorb, gauze pressure, gelatin sponge |
Primary outcome
pain
Time frame: 7 days
VAS visual analogue scale grades (0-10)
1 secondary outcome
closure of the wound
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wisdoms' surgical extractions in people with Bleeding and Pain, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.