Efficacy of a Collagen Hemostatic Dressing After Tooth Extraction

Acteon

Status: Completed

Conditions: Tooth Avulsion

Treatments: Other: Comparator; Device: Hemostatic dressing ETIK COLLAGENE

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05174858

ETIKOL

2021-A02568-33 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Device under investigation

Experimental group

Description:

intra-alveolar placement of the hemostatic dressing ETIK COLLAGENE immediately after tooth extraction.

Treatment:

Device: Hemostatic dressing ETIK COLLAGENE

Comparator

Other group

Description:

the alveolus is left empty after tooth extraction.

Treatment:

Other: Comparator