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Completed

NCT Number: NCT05174858

Efficacy of a Collagen Hemostatic Dressing After Tooth Extraction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculté d'odontologie du CHU Nantes, Nantes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Rate of bleeding at 20 minutes

    Time frame: 20 minutes after tooth extraction

    % patients with bleeding occurring after suture, during the 10-minutes local compression period.

  2. Occurrence of secondary post-extraction bleeding

    Time frame: 7 days

    Number of post-extraction bleeding

  3. Level of pain after dental extraction by a numeric scale

    Time frame: At the end of the oral surgery, day 1, day 2, day 3

    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.

  4. Number of adverse and serious adverse events

    Time frame: From the end of the oral surgery to Day 7

    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.

Sponsors and collaborators

Lead sponsor

ACTEON Group

Industry

Collaborators

  • Slb Pharma

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 3, 2022
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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