search
Back to results

Efficacy of a Collagen Hemostatic Dressing After Tooth Extraction

Primary Purpose

Tooth Avulsion

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hemostatic dressing ETIK COLLAGENE
Comparator
Sponsored by
ACTEON Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Avulsion focused on measuring Hemostasis, tooth extraction, oral surgery, human

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculté d'odontologie du CHU Nantes
  • CSD Rennes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Device under investigation

Comparator

Arm Description

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

the alveolus is left empty after tooth extraction.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of bleeding at 20 minutes
% patients with bleeding occurring after suture, during the 10-minutes local compression period.
Occurrence of secondary post-extraction bleeding
Number of post-extraction bleeding
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.
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.

Full Information

First Posted
December 13, 2021
Last Updated
May 30, 2022
Sponsor
ACTEON Group
Collaborators
Slb Pharma
search

1. Study Identification

Unique Protocol Identification Number
NCT05174858
Brief Title
Efficacy of a Collagen Hemostatic Dressing After Tooth Extraction
Official Title
Efficacy of a Collagen Topical Hemostatic Agent After Tooth Extraction: a Comparative Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 25, 2022 (Actual)
Primary Completion Date
May 20, 2022 (Actual)
Study Completion Date
May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ACTEON Group
Collaborators
Slb Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Avulsion
Keywords
Hemostasis, tooth extraction, oral surgery, human

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study subject will be randomized in a 1:1 allocation ratio between the 2 treatment groups
Masking
Participant
Masking Description
the participant will be blind from the treatment
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device under investigation
Arm Type
Experimental
Arm Description
intra-alveolar placement of the hemostatic dressing ETIK COLLAGENE immediately after tooth extraction.
Arm Title
Comparator
Arm Type
Other
Arm Description
the alveolus is left empty after tooth extraction.
Intervention Type
Device
Intervention Name(s)
Hemostatic dressing ETIK COLLAGENE
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Comparator
Intervention Description
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 Outcome Measure Information:
Title
Assessment of time to hemostasis after tooth extraction
Description
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.
Time Frame
over 8 minutes after tooth extraction
Secondary Outcome Measure Information:
Title
Rate of bleeding at 20 minutes
Description
% patients with bleeding occurring after suture, during the 10-minutes local compression period.
Time Frame
20 minutes after tooth extraction
Title
Occurrence of secondary post-extraction bleeding
Description
Number of post-extraction bleeding
Time Frame
7 days
Title
Level of pain after dental extraction by a numeric scale
Description
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.
Time Frame
At the end of the oral surgery, day 1, day 2, day 3
Title
Number of adverse and serious adverse events
Description
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.
Time Frame
From the end of the oral surgery to Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flora THIBAUT, DDS
Organizational Affiliation
Centre de soins dentaire CHU Rennes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculté d'odontologie du CHU Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
CSD Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of a Collagen Hemostatic Dressing After Tooth Extraction

We'll reach out to this number within 24 hrs