Efficacy of a Collagen Hemostatic Dressing After Tooth Extraction

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

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 Overview

• Status: Completed
• Conditions: Tooth Avulsion
• Intervention / Treatment: Device: Hemostatic dressing ETIK COLLAGENE; Other: Comparator

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44000
    • Faculté d'odontologie du CHU Nantes
  • Rennes, France, 35000
    • CSD Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ACTEON Group
• Collaborators: Slb Pharma
• Investigators: Principal Investigator: Flora THIBAUT, DDS, Centre de soins dentaire CHU Rennes

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2022
• Primary Completion (Actual): May 20, 2022
• Study Completion (Actual): May 20, 2022

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: December 29, 2021
• First Posted (Actual): January 3, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Hemostasis; human; oral surgery; tooth extraction
• Additional Relevant MeSH Terms: Wounds and Injuries; Stomatognathic Diseases; Tooth Diseases; Tooth Injuries; Tooth Avulsion; Coagulants; Hemostatics
• Other Study ID Numbers: ETIKOL; 2021-A02568-33 (Other Identifier: French National Agency oh Health (ANSM))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No