Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A02568-33 | Other Identifier | French National Agency oh Health (ANSM) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Slb Pharma | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device under investigation | Experimental | intra-alveolar placement of the hemostatic dressing ETIK COLLAGENE immediately after tooth extraction. |
|
| Comparator | Other | the alveolus is left empty after tooth extraction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Flora THIBAUT, DDS | Centre de soins dentaire CHU Rennes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculté d'odontologie du CHU Nantes | Nantes | 44000 | France | |||
| CSD Rennes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014084 | Tooth Avulsion |
| ID | Term |
|---|---|
| D018677 | Tooth Injuries |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D014947 | Wounds and Injuries |
Not provided
Not provided
Study subject will be randomized in a 1:1 allocation ratio between the 2 treatment groups
Not provided
Not provided
the participant will be blind from the treatment
| 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. |
|
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 |
| Rennes |
| 35000 |
| France |