HemostasisNCT07529106
Effective Hemostasis: An Analysis of Hemostatic Sponges Used in Extraction Procedures
A study testing Hemostatic sponge post tooth extraction in people with Hemostasis and Wound Closure, run by Universidad Nacional de Caaguazu at 1 site in Paraguay.
Trial summary
Tooth extraction is a common dental procedure, where hemostasis is crucial for patient recovery. This study evaluates the effectiveness of hemostatic sponges in controlling bleeding and promoting postoperative healing. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hemostasis, Wound Closure, Pain
- What is being tested?
- Hemostatic sponge post tooth extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteParaguay
- Study dates
- 8 Aug 2024to 30 Mar 2025
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients over 18 years of age who underwent tooth extractions at the Santo Tomás de Aquino School of Dentistry clinic.
- Teeth to be extracted, both upper and lower.
- Diagnosis of pulp necrosis or irreversible pulpitis, with no possibility of endodontic treatment, impacted teeth, or periodontal disease.
Who cannot join
- Cancer patients undergoing radiotherapy or chemotherapy.
- Smokers and alcoholics.
- Patients who were uncooperative or did not attend follow-up appointments.
- Patients who did not respond to follow-up calls.
Trial locations and contacts
1 site in 1 country.
Paraguay1 site
Universidad Nacional de Caaguazu
Coronel Oviedo, Caaguazú Department, 33000
About this study
Tooth extraction is a common dental procedure, where hemostasis is crucial for patient recovery. This study evaluates the effectiveness of hemostatic sponges in controlling bleeding and promoting postoperative healing.
Read the detailed description
A non-randomized experimental study was conducted at the Santo Tomás de Aquino School of Dentistry Clinic with 30 patients undergoing tooth extractions. They were divided into two groups: one with hemostatic sponges (experimental) and the other without (control). Variables such as bleeding time, wound depth, pain, and postoperative complications at 1, 8, and 15 days were analyzed.
- Conditions
- Hemostasis, Wound Closure, Pain, Extraction Socket Healing
- Being tested
- Hemostatic sponge post tooth extraction
- Keywords
- hemostatic sponges, tooth extraction, wound healing, postoperative complications, hemostasis
- Medical subject headings
- Pain, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemostatic sponge post tooth extractionProcedure or surgery
Effectiveness of hemostatic sponges in patients undergoing tooth extractions, analyzing immediate hemostasis and scar development at different postoperative times.
| Study group | Role | What they receive |
|---|---|---|
| Hemostatic sponge | Experimental | The colocation of a hemostatic sponge post extraction in the wound Receives: Procedure: Hemostatic sponge post tooth extraction |
| No intervention | No intervention | No colocation of hemostatic sponge in the wound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-tooth extraction hemostasis.
Time measured in minutes from the end of the extraction procedure until complete bleeding cessation, assessed by direct clinical observation.
Measured: From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15
Wound dimensional changes
Measurement of socket length, width, and depth using calibrated periodontal probe. Data will be reported as mean change in millimeters from baseline measurement.
Measured: From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15
Pain intensity
Pain intensity measured using Visual Analog Scale (VAS). Higher scores indicate worse outcome.
Measured: From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15
Edema assessment
Edema assessed by clinical examination using a 4-point scale: 0 = no edema, 1 = mild edema, 2 = moderate edema, 3 = severe edema. Higher scores indicate worse outcome.
Measured: From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15
Tissue color changes evaluation
Evaluation of tissue color changes using a standardized 5-point wound healing color scale: 1 = normal pink, 2 = pale pink, 3 = red, 4 = dark red/purple, 5 = black/necrotic. Higher scores indicate worse healing.
Measured: From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15
Post-extraction complications
Incidence of post-extraction complications including but not limited to: dry socket, infection, delayed healing, excessive bleeding, and nerve damage. Complications will be assessed by clinical examination and participant reporting.
Measured: From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start8 Aug 2024
- Primary completion15 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemostasisStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A sample of 30 patients was selected, divided into two groups of 15 patients each: an experimental group, which received treatment with hemostatic sponges, and a control group, which did not receive such treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Caaguazu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sofia Monzon, DDs, Principal investigator, Universidad Nacional de Caaguazu, Grupo Salud Oral y Biomateriales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529106
- Sponsor's protocol ID
- FOUNCA09/2024
- Status last verified
- Apr 2026
- First submitted
- 8 Dec 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On request
Publications
Mahmoudi A, Ghavimi MA, Maleki Dizaj S, Sharifi S, Sajjadi SS, Jamei Khosroshahi AR. Efficacy of a New Hemostatic Dental Sponge in Controlling Bleeding, Pain, and Dry Socket Following Mandibular Posterior Teeth Extraction-A Split-Mouth Randomized Double-Blind Clinical Trial. J Clin Med. 2023 Jul 10;12(14):4578. doi: 10.3390/jcm12144578.
PubMed 37510692
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Hemostasis: An Analysis of Hemostatic Sponges Used in Extraction Procedures
- ClinicalTrials.gov ID
- NCT07529106
- Acronym / sponsor ID
- FOUNCA09/2024
- Conditions
- Hemostasis, Wound Closure, Pain, Extraction Socket Healing
- Keywords
- hemostatic sponges, tooth extraction, wound healing, postoperative complications, hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Nacional de CaaguazuUniversity, hospital or other
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 14 Apr 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.
Tooth extraction is a common dental procedure, where hemostasis is crucial for patient recovery. This study evaluates the effectiveness of hemostatic sponges in controlling bleeding and promoting postoperative healing.
Detailed description
A non-randomized experimental study was conducted at the Santo Tomás de Aquino School of Dentistry Clinic with 30 patients undergoing tooth extractions. They were divided into two groups: one with hemostatic sponges (experimental) and the other without (control). Variables such as bleeding time, wound depth, pain, and postoperative complications at 1, 8, and 15 days were analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A sample of 30 patients was selected, divided into two groups of 15 patients each: an experimental group, which received treatment with hemostatic sponges, and a control group, which did not receive such treatment.
| Arm | Type | Receives |
|---|---|---|
| Hemostatic sponge | Experimental | Procedure: Hemostatic sponge post tooth extractionThe colocation of a hemostatic sponge post extraction in the wound |
| No intervention | No intervention | –No colocation of hemostatic sponge in the wound |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients over 18 years of age who underwent tooth extractions at the Santo Tomás de Aquino School of Dentistry clinic.
- Teeth to be extracted, both upper and lower.
- Diagnosis of pulp necrosis or irreversible pulpitis, with no possibility of endodontic treatment, impacted teeth, or periodontal disease.
Key exclusion criteria (4 listed)
- Cancer patients undergoing radiotherapy or chemotherapy.
- Smokers and alcoholics.
- Patients who were uncooperative or did not attend follow-up appointments.
- Patients who did not respond to follow-up calls.
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 sponge post tooth extractionEffectiveness of hemostatic sponges in patients undergoing tooth extractions, analyzing immediate hemostasis and scar development at different postoperative times. | Procedure or surgery | Hemostatic sponge |
Primary outcome
Post-tooth extraction hemostasis.
Time frame: From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15
Time measured in minutes from the end of the extraction procedure until complete bleeding cessation, assessed by direct clinical observation.
Wound dimensional changes
Time frame: From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15
Measurement of socket length, width, and depth using calibrated periodontal probe. Data will be reported as mean change in millimeters from baseline measurement.
Pain intensity
Time frame: From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15
Pain intensity measured using Visual Analog Scale (VAS). Higher scores indicate worse outcome.
Edema assessment
Time frame: From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15
Edema assessed by clinical examination using a 4-point scale: 0 = no edema, 1 = mild edema, 2 = moderate edema, 3 = severe edema. Higher scores indicate worse outcome.
Tissue color changes evaluation
Time frame: From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15
Evaluation of tissue color changes using a standardized 5-point wound healing color scale: 1 = normal pink, 2 = pale pink, 3 = red, 4 = dark red/purple, 5 = black/necrotic. Higher scores indicate worse healing.
Post-extraction complications
Time frame: From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15
Incidence of post-extraction complications including but not limited to: dry socket, infection, delayed healing, excessive bleeding, and nerve damage. Complications will be assessed by clinical examination and participant reporting.
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 14 Apr 2026.
- Background: PubMed 37510692Mahmoudi A, Ghavimi MA, Maleki Dizaj S, Sharifi S, Sajjadi SS, Jamei Khosroshahi AR. Efficacy of a New Hemostatic Dental Sponge in Controlling Bleeding, Pain, and Dry Socket Following Mandibular Posterior Teeth Extraction-A Split-Mouth Randomized Double-Blind Clinical Trial. J Clin Med. 2023 Jul 10;12(14):4578. doi: 10.3390/jcm12144578.
- Individual participant dataSharing planned: Yes. On request
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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.
Sofia Monzon, DDs principal investigator
Universidad Nacional de Caaguazu, Grupo Salud Oral y Biomateriales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemostatic sponge post tooth extraction in people with Hemostasis and Wound Closure, run by Universidad Nacional de Caaguazu at 1 site in Paraguay.
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 3 inclusion and 4 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 14 Apr 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 Paraguay. 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.
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?
Post-tooth extraction hemostasis. (time frame: From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07529106, which also lists 1 linked publication.
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 14 Apr 2026.