Efficacy of a Collagen Hemostatic Dressing After Tooth Extraction

Tooth Avulsion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05174858
• Other study ID #: ETIKOL
• Secondary ID: 2021-A02568-33
• Status: Completed
• Phase: N/A
• Start date: January 25, 2022
• Est. completion date: May 20, 2022

Study information

• Verified date: May 2022
• Source: ACTEON Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tooth Avulsion

Intervention

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. 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.

Locations

Country	Name	City	State
France	Faculté d'odontologie du CHU Nantes	Nantes
France	CSD Rennes	Rennes

Sponsors (2)

Lead Sponsor	Collaborator
ACTEON Group	Slb Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of bleeding at 20 minutes	% patients with bleeding occurring after suture, during the 10-minutes local compression period.	20 minutes after tooth extraction
Secondary	Occurrence of secondary post-extraction bleeding	Number of post-extraction bleeding	7 days
Secondary	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
Secondary	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