Efficacy of a Collagen Hemostatic Dressing After Tooth Extraction
NCT ID: NCT05174858
Last Updated: 2022-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2022-01-25
2022-05-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Device under investigation
intra-alveolar placement of the hemostatic dressing ETIK COLLAGENE immediately after tooth extraction.
Hemostatic dressing ETIK COLLAGENE
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.
Comparator
the alveolus is left empty after tooth extraction.
Comparator
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.
Interventions
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Hemostatic dressing ETIK COLLAGENE
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.
Comparator
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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,
* 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.
18 Years
ALL
No
Sponsors
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Slb Pharma
OTHER
ACTEON Group
INDUSTRY
Responsible Party
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Principal Investigators
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Flora THIBAUT, DDS
Role: PRINCIPAL_INVESTIGATOR
Centre de soins dentaire CHU Rennes
Locations
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Faculté d'odontologie du CHU Nantes
Nantes, , France
CSD Rennes
Rennes, , France
Countries
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Other Identifiers
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2021-A02568-33
Identifier Type: OTHER
Identifier Source: secondary_id
ETIKOL
Identifier Type: -
Identifier Source: org_study_id
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