Tooth AvulsionNCT05174858
Efficacy of a Collagen Hemostatic Dressing After Tooth Extraction
A study testing Hemostatic dressing ETIK COLLAGENE and Comparator in people with Tooth Avulsion, run by ACTEON Group at 2 sites in France.
Trial summary
This study is a multicentric randomised (2 groups, ratio 1:1) Post Market Clinical Follow-up trial. 38 subjects (teeth) requiring a simple tooth extraction or multiple tooth extraction on the same quadrant and taking curative or preventive antithrombotic treatment will be included (19 in each group). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Avulsion
- What is being tested?
- Hemostatic dressing ETIK COLLAGENE and Comparator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Jan 2022to 20 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age > 18 years old,
- Patient undergoing a simple tooth extraction or multiple tooth extraction on the same quadrant,
- Patient taking curative or preventive antithrombotic treatment or patient with a moderate thrombocytopenia,
- Patient reachable after surgery,
- Signed informed consent form,
- Subject affiliated to a health insurance system, or is a beneficiary.
Who cannot join
- Known allergy to bovine collagen,
- Preoperative INR<1.5 or >3 or instable,
- Patient with high risk of bleeding, history of postoperative hemorrhagic complication,
- Treatment with bone resorption inhibitor, or patient irradiated at the cervico-facial level,
- Contraindication to anesthesia using articaine with 1:200,000 epinephrine,
- Clinical follow-up expected to be difficult,
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- Presence of uncontrolled hypertension, uncompensated diabetes or other clinically relevant systemic alterations,
- Current participation in another clinical trial or subject still within the exclusion period of a previous clinical trial,
- Vulnerable subjects.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Faculté d'odontologie du CHU Nantes
Nantes, 44000
CSD Rennes
Rennes, 35000
About this study
Official title: Efficacy of a Collagen Topical Hemostatic Agent After Tooth Extraction: a Comparative Randomized Clinical Trial
This study is a multicentric randomised (2 groups, ratio 1:1) Post Market Clinical Follow-up trial. 38 subjects (teeth) requiring a simple tooth extraction or multiple tooth extraction on the same quadrant and taking curative or preventive antithrombotic treatment will be included (19 in each group).
The aim of the study is to assess the efficacy of ETIK COLLAGENE (Topical hemostatic collagen-product) on the hemostasis (time to stop bleeding) after tooth extraction.
Read more
The hemostasis is measured by assessing the presence of bleeding within the first 8 minutes post-extraction.
Group 1: intra-alveolar placement of ETIK COLLAGENE immediately after tooth extraction.
Group 2: the alveolus is left empty after tooth extraction (the use of ETIK COLLAGENE is delayed 8 minutes after tooth extraction, before suture).
Subjects will be followed-up to 7 days.
- Conditions
- Tooth Avulsion
- Being tested
- Hemostatic dressing ETIK COLLAGENE, Comparator
- Keywords
- Hemostasis, tooth extraction, oral surgery, human
- Medical subject headings
- Tooth Avulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemostatic dressing ETIK COLLAGENEDevice
The hemostatic dressing ETIK COLLAGENE is placed in the alveolus immediately after tooth extraction. The presence of bleeding in the alveolus is assessed every 30 seconds for 8 minutes; then the surgical site is sutured.
ComparatorOther
The alveolus is left empty after tooth extraction. The presence of bleeding in the alveolus is assessed every 30 seconds for 8 minutes; then the dressing ETIK COLLAGENE is placed in the alveolus and the surgical site is sutured.
| Study group | Role | What they receive |
|---|---|---|
| Device under investigation | Experimental | intra-alveolar placement of the hemostatic dressing ETIK COLLAGENE immediately after tooth extraction. Receives: Device: Hemostatic dressing ETIK COLLAGENE |
| Comparator | Other | the alveolus is left empty after tooth extraction. Receives: Other: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of time to hemostasis after tooth extraction
For each patient, the time to stop bleeding (expressed in minutes) is assessed as follows : every 30 seconds from the tooth extraction (T0) to 8 minutes post extraction, the oral surgeon observes the alveolus during 5 seconds and records the presence or absence of bleeding.
Measured: over 8 minutes after tooth extraction
Secondary outcomes (4)
Rate of bleeding at 20 minutes
% patients with bleeding occurring after suture, during the 10-minutes local compression period.
Measured: 20 minutes after tooth extraction
Occurrence of secondary post-extraction bleeding
Number of post-extraction bleeding
Measured: 7 days
Level of pain after dental extraction by a numeric scale
The pain is assessed by patients in a diary using a numeric scale (range from 0 (= no pain) to 10 (= the worst pain)) each day from the end of the oral surgery to Day 3.
Measured: At the end of the oral surgery, day 1, day 2, day 3
Number of adverse and serious adverse events
Adverse events recorded from the tooth extraction to the end of follow-up visit will be used to assess the safety of hemostatic dressing and surgical procedures.
Measured: From the end of the oral surgery to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start25 Jan 2022
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth AvulsionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study subject will be randomized in a 1:1 allocation ratio between the 2 treatment groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACTEON Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Responsible party
- Sponsor
- Investigators
- Flora THIBAUT, DDS, Principal investigator, Centre de soins dentaire CHU Rennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174858
- Sponsor's protocol ID
- ETIKOL
- Other IDs
- 2021-A02568-33
- Status last verified
- May 2022
- First submitted
- 13 Dec 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Collagen Topical Hemostatic Agent After Tooth Extraction: a Comparative Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05174858
- Acronym / sponsor ID
- ETIKOL
- Conditions
- Tooth Avulsion
- Keywords
- Hemostasis, tooth extraction, oral surgery, human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- ACTEON GroupIndustry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 3 Jan 2022 (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 is a multicentric randomised (2 groups, ratio 1:1) Post Market Clinical Follow-up trial. 38 subjects (teeth) requiring a simple tooth extraction or multiple tooth extraction on the same quadrant and taking curative or preventive antithrombotic treatment will be included (19 in each group).
The aim of the study is to assess the efficacy of ETIK COLLAGENE (Topical hemostatic collagen-product) on the hemostasis (time to stop bleeding) after tooth extraction.
The hemostasis is measured by assessing the presence of bleeding within the first 8 minutes post-extraction.
Group 1: intra-alveolar placement of ETIK COLLAGENE immediately after tooth extraction.
Group 2: the alveolus is left empty after tooth extraction (the use of ETIK COLLAGENE is delayed 8 minutes after tooth extraction, before suture).
Subjects will be followed-up to 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Study subject will be randomized in a 1:1 allocation ratio between the 2 treatment groups
| Arm | Type | Receives |
|---|---|---|
| Device under investigation | Experimental | Device: Hemostatic dressing ETIK COLLAGENEintra-alveolar placement of the hemostatic dressing ETIK COLLAGENE immediately after tooth extraction. |
| Comparator | Other | Other: Comparatorthe alveolus is left empty after tooth extraction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, age > 18 years old,
- Patient undergoing a simple tooth extraction or multiple tooth extraction on the same quadrant,
- Patient taking curative or preventive antithrombotic treatment or patient with a moderate thrombocytopenia,
- Patient reachable after surgery,
- Signed informed consent form,
Key exclusion criteria (9 listed)
- Known allergy to bovine collagen,
- Preoperative INR<1.5 or >3 or instable,
- Patient with high risk of bleeding, history of postoperative hemorrhagic complication,
- Treatment with bone resorption inhibitor, or patient irradiated at the cervico-facial level,
- Contraindication to anesthesia using articaine with 1:200,000 epinephrine,
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 dressing ETIK COLLAGENEThe hemostatic dressing ETIK COLLAGENE is placed in the alveolus immediately after tooth extraction. The presence of bleeding in the alveolus is assessed every 30 seconds for 8 minutes; then the surgical site is sutured. | Device | Device under investigation |
| ComparatorThe alveolus is left empty after tooth extraction. The presence of bleeding in the alveolus is assessed every 30 seconds for 8 minutes; then the dressing ETIK COLLAGENE is placed in the alveolus and the surgical site is sutured. | Other | Comparator |
Primary outcome
Assessment of time to hemostasis after tooth extraction
Time frame: over 8 minutes after tooth extraction
For each patient, the time to stop bleeding (expressed in minutes) is assessed as follows : every 30 seconds from the tooth extraction (T0) to 8 minutes post extraction, the oral surgeon observes the alveolus during 5 seconds and records the presence or absence of bleeding.
4 secondary outcomes
Rate of bleeding at 20 minutes
Time frame: 20 minutes after tooth extraction
Occurrence of secondary post-extraction bleeding
Time frame: 7 days
Level of pain after dental extraction by a numeric scale
Time frame: At the end of the oral surgery, day 1, day 2, day 3
Number of adverse and serious adverse events
Time frame: From the end of the oral surgery to Day 7
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 1 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Flora THIBAUT, DDS principal investigator
Centre de soins dentaire CHU Rennes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemostatic dressing ETIK COLLAGENE and Comparator in people with Tooth Avulsion, run by ACTEON Group at 2 sites in France.
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 6 inclusion and 9 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 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Assessment of time to hemostasis after tooth extraction (time frame: over 8 minutes after tooth extraction). 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 1 Jun 2022.