Efficacy of a Collagen Hemostatic Dressing After Tooth Extraction

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of a Collagen Topical Hemostatic Agent After Tooth Extraction: a Comparative Randomized Clinical Trial

Conditions
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Tooth Avulsion

Intervention / Treatment
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* Device: Hemostatic dressing ETIK COLLAGENE
* Other: Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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, 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study subject will be randomized in a 1:1 allocation ratio between the 2 treatment groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device under investigation<br>intra-alveolar placement of the hemostatic dressing ETIK COLLAGENE immediately after tooth extraction. | Device: Hemostatic dressing ETIK COLLAGENE<br>* 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.<br>|
| Other: Comparator<br>the alveolus is left empty after tooth extraction. | Other: Comparator<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | over 8 minutes after tooth extraction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of bleeding at 20 minutes | % patients with bleeding occurring after suture, during the 10-minutes local compression period. | 20 minutes after tooth extraction | 
| Occurrence of secondary post-extraction bleeding | Number of post-extraction bleeding | 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. | 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. | From the end of the oral surgery to Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemostasis, tooth extraction, oral surgery, human