Efficacy of a Collagen Hemostatic Dressing After Tooth Extraction

NCT05174858 | Completed

• 2 other identifiers: ETIKOL2021-A02568-33
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Tooth Avulsion

Keywords

Hemostasis; tooth extraction; oral surgery; human

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Device under investigation

EXPERIMENTAL

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

Device: Hemostatic dressing ETIK COLLAGENE

Comparator

OTHER

the alveolus is left empty after tooth extraction.

Other: Comparator

Interventions

Hemostatic dressing ETIK COLLAGENE DEVICE

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.

Device under investigation

Comparator OTHER

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.

Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• Vulnerable subjects.

Sponsors & Collaborators

• ACTEON Group: lead
• Slb Pharma: collaborator

Study Sites (2)

Faculté d'odontologie du CHU Nantes

Nantes, 44000, France

Location

CSD Rennes

Rennes, 35000, France

Location

MeSH Terms

Conditions

Tooth Avulsion

Condition Hierarchy (Ancestors)

Tooth Injuries; Tooth Diseases; Stomatognathic Diseases; Wounds and Injuries

Study Officials

• Flora THIBAUT, DDS

  Centre de soins dentaire CHU Rennes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the participant will be blind from the treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study subject will be randomized in a 1:1 allocation ratio between the 2 treatment groups

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 3, 2022
• Study Start: January 25, 2022
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)