Efficacy of a Collagen Hemostatic Dressing After Tooth Extraction
- Conditions
- Tooth Avulsion
- Interventions
- Other: ComparatorDevice: Hemostatic dressing ETIK COLLAGENE
- Registration Number
- NCT05174858
- Lead Sponsor
- ACTEON Group
- Brief 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).
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comparator Comparator the alveolus is left empty after tooth extraction. Device under investigation Hemostatic dressing ETIK COLLAGENE intra-alveolar placement of the hemostatic dressing ETIK COLLAGENE immediately after tooth extraction.
- Primary Outcome Measures
Name Time Method Assessment of time to hemostasis after tooth extraction 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.
- Secondary Outcome Measures
Name Time Method Number of adverse and serious adverse events From the end of the oral surgery to Day 7 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.
Rate of bleeding at 20 minutes 20 minutes after tooth extraction % patients with bleeding occurring after suture, during the 10-minutes local compression period.
Occurrence of secondary post-extraction bleeding 7 days Number of post-extraction bleeding
Level of pain after dental extraction by a numeric scale At the end of the oral surgery, day 1, day 2, day 3 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.
Trial Locations
- Locations (2)
Faculté d'odontologie du CHU Nantes
🇫🇷Nantes, France
CSD Rennes
🇫🇷Rennes, France