Clinical trial NCT05174858: Efficacy of a Collagen Hemostatic Dressing After Tooth Extraction
Official title: Efficacy of a Collagen Topical Hemostatic Agent After Tooth Extraction: a Comparative Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Avulsion
Keywords: Hemostasis
tooth extraction
oral surgery
human
Lead sponsor: ACTEON Group
Sponsor class: INDUSTRY
Collaborators: name: Slb Pharma
First posted: 2022-01-03
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study subject will be randomized in a 1:1 allocation ratio between the 2 treatment groups
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of time to hemostasis after tooth extraction
timeFrame: over 8 minutes after tooth extraction
Secondary outcomes:
measure: Rate of bleeding at 20 minutes
timeFrame: 20 minutes after tooth extraction
measure: Occurrence of secondary post-extraction bleeding
timeFrame: 7 days
measure: Level of pain after dental extraction by a numeric scale
timeFrame: At the end of the oral surgery, day 1, day 2, day 3
measure: Number of adverse and serious adverse events
timeFrame: From the end of the oral surgery to Day 7
Other outcomes:
Locations:
city: Nantes
country: France
facility: Faculté d'odontologie du CHU Nantes
city: Rennes
country: France
facility: CSD Rennes
Study officials:
affiliation: Centre de soins dentaire CHU Rennes
name: Flora THIBAUT, DDS
role: PRINCIPAL_INVESTIGATOR
References: