Efficacy of a Collagen Topical Hemostatic Agent After Tooth Extraction: a Comparative Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 38
- Locations
- 4
- Primary Endpoint
- Assessment of time to hemostasis after tooth extraction
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
the participant will be blind from the treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Rate of bleeding at 20 minutes(20 minutes after tooth extraction)
- Occurrence of secondary post-extraction bleeding(7 days)
- Level of pain after dental extraction by a numeric scale(At the end of the oral surgery, day 1, day 2, day 3)
- Number of adverse and serious adverse events(From the end of the oral surgery to Day 7)