Molar Extraction SocketEarly Phase 1NCT07179523
Clinical Evaluation of the Effectiveness of Biomimetic Hemostatic Sponges ColiSorB Following Dental Extraction
A Early Phase 1 study testing Hemostatic gelatin sponge and Hemostatic Agent in people with Molar Extraction Socket, run by Sara Omar at 1 site in Egypt.
Trial 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 qualified to join. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Molar Extraction Socket
- What is being tested?
- Hemostatic gelatin sponge and Hemostatic Agent
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Oct 2023
- Phase
- Early Phase 1
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site
Department of Oral & maxillofacial surgery at Cairo University
Cairo, Giza Governorate, 12613
About this study
Official title: Randomized Clinical Evaluation of the Effectiveness of Biomimetic Hemostatic Sponges ColiSorB Following Dental Extraction
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.
Read the 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 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):
- Test group: ColiSorB® hemostatic sponge.
- Comparator group: Cutanplast®, a commercially available gelatin-based hemostatic product.
- 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.
- Conditions
- Molar Extraction Socket
- Being tested
- Hemostatic gelatin sponge, Hemostatic Agent
- Keywords
- ColiSorB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemostatic gelatin spongeCombination product
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.
Hemostatic AgentCombination product
Also called Cutanplast
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Conventional cotton and gauze were applied with firm pressure on the extraction site |
| Experimental Comparator Group | Active comparator | A commercially available hemostatic sponge was used, namely Cutanplast. Receives: Combination Product: Hemostatic Agent |
| Experimental Group | Experimental | A newly developed hemostatic gelatin sponge called Colisorb was used Receives: Combination Product: Hemostatic gelatin sponge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to achieve full absorption and hemostasis
Time (in minutes) from baseline (application of the assigned dressing immediately after tooth extraction) until complete hemostasis is achieved, defined as cessation of visible bleeding at the extraction site.
Measured: Assessed from baseline until hemostasis is achieved (within 1 day).
Time of placement
Duration (in minutes) required at baseline to apply the assigned dressing (sponge or standard gauze) at the extraction site, including any pre-wetting step if applicable.
Measured: Assessed at baseline (time of dressing application immediately after tooth extraction).
Secondary outcomes (1)
Pain and Healing Scale
Patients comfort level is assessed by a verbal inquiry after completion of the operation and dressing application ( post- operation).
Pain scores: Patient-reported pain scores assessed on day 1, and day 7 of post-procedure appointment. Based on a 0 to 10 self-reported pain score basis, with 0 being no pain and 10 being the worst pain the patient had ever experienced.
Healing: Sealing of the wound was assessed on day 1, and day 7 post-operation. Using a modified scale adopted from Landry, Turnbull and Howley healing Index. The parameters based on which the wound sealing is assessed include tissue color, bleeding on palpation, granulation tissue, incision margin and suppuration. The adjusted scale was as follows: 1 (significantly getting worse or very poor), 2 (moderate), and 3 (significantly better or excellent).
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Sep 2023
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Extraction SocketStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Omar
- Sponsor type
- University, hospital or other
- Collaborators
- Incura Inc.
- Responsible party
- Sponsor-investigator, Sara Omar, The American University in Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179523
- Sponsor's protocol ID
- 26522
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared for this study. The data are considered the property of the study sponsor and the collaborator, will remain confidential.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Evaluation of the Effectiveness of Biomimetic Hemostatic Sponges ColiSorB Following Dental Extraction
- ClinicalTrials.gov ID
- NCT07179523
- Acronym / sponsor ID
- 26522
- Conditions
- Molar Extraction Socket
- Keywords
- ColiSorB
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sara OmarUniversity, hospital or other
- Collaborators
- Incura Inc.
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 18 Sep 2025 (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.
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.
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 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):
- Test group: ColiSorB® hemostatic sponge.
- Comparator group: Cutanplast®, a commercially available gelatin-based hemostatic product.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Conventional cotton and gauze were applied with firm pressure on the extraction site |
| Experimental Comparator Group | Active comparator | Combination Product: Hemostatic AgentA commercially available hemostatic sponge was used, namely Cutanplast. |
| Experimental Group | Experimental | Combination Product: Hemostatic gelatin spongeA newly developed hemostatic gelatin sponge called Colisorb was used |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients seeking removal of a wisdom tooth due to:
- Severe decay
- Malposition/misalignment
- Pressure caries affecting adjacent teeth
- Indication for future orthodontic treatment
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Hemostatic gelatin spongeColisorb® 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 | Experimental Group |
| Hemostatic AgentAlso: CutanplastGelatin 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. | Combination product | Experimental Comparator Group |
Primary outcome
Time to achieve full absorption and hemostasis
Time frame: Assessed from baseline until hemostasis is achieved (within 1 day).
Time (in minutes) from baseline (application of the assigned dressing immediately after tooth extraction) until complete hemostasis is achieved, defined as cessation of visible bleeding at the extraction site.
Time of placement
Time frame: Assessed at baseline (time of dressing application immediately after tooth extraction).
Duration (in minutes) required at baseline to apply the assigned dressing (sponge or standard gauze) at the extraction site, including any pre-wetting step if applicable.
1 secondary outcome
Pain and Healing Scale
Time frame: Up to 7 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 25 Sep 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared for this study. The data are considered the property of the study sponsor and the collaborator, will remain confidential.
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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 Early Phase 1 study testing Hemostatic gelatin sponge and Hemostatic Agent in people with Molar Extraction Socket, run by Sara Omar 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 8 inclusion and 8 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 25 Sep 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to achieve full absorption and hemostasis (time frame: Assessed from baseline until hemostasis is achieved (within 1 day).). The study lists 2 primary outcomes in all. 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 25 Sep 2025.