CompletedNot Applicable

Efficacy of a Collagen Hemostatic Dressing After Tooth Extraction

France38 participantsStarted 2022-01-25

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of time to hemostasis after tooth extraction

Timeframe: over 8 minutes after tooth extraction

Trial details

NCT IDNCT05174858

SponsorACTEON Group

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-20

View on ClinicalTrials.gov More Tooth Avulsion trials