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Cow collagen sponge stops bleeding in dental surgery

NCT ID NCT05171231

Disease control Sponsor: Septodont Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well a sponge made from cow collagen, called HEMOCOLLAGENE®, stops bleeding after oral surgery. 125 patients who had bleeding after dental procedures were treated with the sponge. The main goal was to see if bleeding stopped within 5 minutes. The study also checked for side effects and how well the wound healed over one month.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HEMOCOLLAGENE® (absorbable collagen sponge made from bovine collagen)
What this could lead to
If successful, this could confirm HEMOCOLLAGENE® as a safe and effective option for controlling bleeding after dental surgery.
What could go wrong
This is a small, completed observational study without a comparison group, so results may not apply to all patients. The sponge is made from cow collagen, which could cause allergic reactions in some people.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

125 people

The number who actually took part.

Started

Nov 2021

Finished

Mar 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population is made with the recruitment of participating centers which included at least one patient. The analysis will be carried out on the patients included with evaluable observation sheets . The evaluability of a form will be defined during the development of the analysis plan according to the number of missing data and the nature of missing data. The analysis sets are defined below: * Intented-to-treat (ITT) population: The ITT population consists of all subjects not opposed to the use of their clinical data and implanted by the HEMOCOLLAGENE® medical device. This population will be the primary population analysis for safety and efficacy. * Per Protocol (PP): The PP population includes all the patients implanted by the medical device HEMOCOLLAGENE® without any major deviation from the protocol. Protocol violations will be graded (major / minor) when reviewing data before database lock. This population will be the secondary population analysis.

Ages

10 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient requiring oral surgery * Patient with a bleeding requiring the use of an adjuvant hemostatic * Patient implanted with HEMOCOLLAGENE® in dental surgery. * Patient who signed his informed consent form Exclusion Criteria: * Inform Consent not signed * Patients with acute oral infection. * Patients with an unstable hemodynamic state (acute and/or chronic cardiovascular pathology, low arterial pressure, cardiac rhythm problem) * Pregnant and / or breastfeeding patients. * Patient with hypersensitivity or allergy to bovine collagen

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Conditions

The condition(s) this trial relates to.

Oral Hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Oral hemorrhage

Contacts and locations

Locations

  • APHP- Hôpital de la Pitié Salpetrière

    Paris, 75004, France

  • Cabinet Dentaire

    Brussels, 1180, Belgium

  • Cabinet Dento Médical, cabinet de Nivelles

    Baulers, 4 B-1401, Belgium

  • Cabinet Medical

    Lyon, 69003, France

  • Cabinet dentaire

    Chassieu, 69680, France

  • Cabinet dentaire

    Roanne, 42300, France

  • Cabinet dentaire

    Villefranche-sur-Saône, 69400, France

  • Cabinet dentaire Grange-Blanche

    Lyon, 69008, France

  • HCL-Hospices Civil de Lyon

    Lyon, 69007, France

  • SCM Chirurgie Dentaire Opéra

    Lyon, 69001, France