Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT05174858
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2021-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of a Collagen Hemostatic Dressing After Tooth Extraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014084', 'term': 'Tooth Avulsion'}], 'ancestors': [{'id': 'D018677', 'term': 'Tooth Injuries'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'the participant will be blind from the treatment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Study subject will be randomized in a 1:1 allocation ratio between the 2 treatment groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-30', 'studyFirstSubmitDate': '2021-12-13', 'studyFirstSubmitQcDate': '2021-12-29', 'lastUpdatePostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of time to hemostasis after tooth extraction', 'timeFrame': 'over 8 minutes 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.'}], 'secondaryOutcomes': [{'measure': 'Rate of bleeding at 20 minutes', 'timeFrame': '20 minutes after tooth extraction', 'description': '% patients with bleeding occurring after suture, during the 10-minutes local compression period.'}, {'measure': 'Occurrence of secondary post-extraction bleeding', 'timeFrame': '7 days', 'description': 'Number of post-extraction bleeding'}, {'measure': 'Level of pain after dental extraction by a numeric scale', 'timeFrame': 'At the end of the oral surgery, day 1, day 2, day 3', '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.'}, {'measure': 'Number of adverse and serious adverse events', 'timeFrame': 'From the end of the oral surgery to Day 7', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemostasis', 'tooth extraction', 'oral surgery', 'human'], 'conditions': ['Tooth Avulsion']}, 'descriptionModule': {'briefSummary': '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).\n\nThe 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.\n\nThe hemostasis is measured by assessing the presence of bleeding within the first 8 minutes post-extraction.\n\nGroup 1: intra-alveolar placement of ETIK COLLAGENE immediately after tooth extraction.\n\nGroup 2: the alveolus is left empty after tooth extraction (the use of ETIK COLLAGENE is delayed 8 minutes after tooth extraction, before suture).\n\nSubjects will be followed-up to 7 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, age \\> 18 years old,\n* Patient undergoing a simple tooth extraction or multiple tooth extraction on the same quadrant,\n* Patient taking curative or preventive antithrombotic treatment or patient with a moderate thrombocytopenia,\n* Patient reachable after surgery,\n* Signed informed consent form,\n* Subject affiliated to a health insurance system, or is a beneficiary.\n\nExclusion Criteria:\n\n* Known allergy to bovine collagen,\n* Preoperative INR\\<1.5 or \\>3 or instable,\n* Patient with high risk of bleeding, history of postoperative hemorrhagic complication,\n* Treatment with bone resorption inhibitor, or patient irradiated at the cervico-facial level,\n* Contraindication to anesthesia using articaine with 1:200,000 epinephrine,\n* Clinical follow-up expected to be difficult,\n* Presence of uncontrolled hypertension, uncompensated diabetes or other clinically relevant systemic alterations,\n* Current participation in another clinical trial or subject still within the exclusion period of a previous clinical trial,\n* Vulnerable subjects.'}, 'identificationModule': {'nctId': 'NCT05174858', 'briefTitle': 'Efficacy of a Collagen Hemostatic Dressing After Tooth Extraction', 'organization': {'class': 'INDUSTRY', 'fullName': 'ACTEON Group'}, 'officialTitle': 'Efficacy of a Collagen Topical Hemostatic Agent After Tooth Extraction: a Comparative Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'ETIKOL'}, 'secondaryIdInfos': [{'id': '2021-A02568-33', 'type': 'OTHER', 'domain': 'French National Agency oh Health (ANSM)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device under investigation', 'description': 'intra-alveolar placement of the hemostatic dressing ETIK COLLAGENE immediately after tooth extraction.', 'interventionNames': ['Device: Hemostatic dressing ETIK COLLAGENE']}, {'type': 'OTHER', 'label': 'Comparator', 'description': 'the alveolus is left empty after tooth extraction.', 'interventionNames': ['Other: Comparator']}], 'interventions': [{'name': 'Hemostatic dressing ETIK COLLAGENE', 'type': 'DEVICE', '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.', 'armGroupLabels': ['Device under investigation']}, {'name': 'Comparator', 'type': 'OTHER', '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.', 'armGroupLabels': ['Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': "Faculté d'odontologie du CHU Nantes", 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'CSD Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Flora THIBAUT, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de soins dentaire CHU Rennes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ACTEON Group', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Slb Pharma', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}