Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-02-21 @ 12:19 AM
Study NCT ID:
NCT05747092
Status:
UNKNOWN
Last Update Posted:
2023-02-28
First Post:
2023-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Killer, Anxiety and Mucogingival Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'group test free gingival graft group control connective tissue graft'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-16', 'studyFirstSubmitDate': '2023-01-27', 'studyFirstSubmitQcDate': '2023-02-16', 'lastUpdatePostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pin killer consumption', 'timeFrame': 'two weeks', 'description': 'the number of pain killer used after treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety and Depression']}, 'descriptionModule': {'briefSummary': 'Is the pain killer consumption after gingival treatment related to the level of patient anxiety or to the type of therapy?', 'detailedDescription': 'Anxiety and depression (HAD) scale used could be reveal the level of the patient anxiety and/or depression before intervention.\n\nAdditionnaly the use of these specific questionnaires (7 items for anxiety, 7 items for depression) could reveal if the pain killer consumption after gingical treatment is dependant to the level of HAD or to the therapy .\n\nThis tool (HAD) could allows to recognize, before any (oral)surgery, profil with high risk and propose solution to decrease anxiety and/or depression before treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA type I and II subjects\n* Localized Gingival Recessions\n* Recessions Cairo RT I-II\n* FMPS \\< 10%\n* FMBS\\< 10%\n* \\<10 cigs/ day\n* No contra-indication against oral surgical interventions\n* Patient is able to give inform consent\n\nExclusion Criteria:\n\n* Infection (local or systemic). Each infection will be evaluated prior to study procedure for suitability. Patients with gingivitis or local infection (fracture, apical reaction) will undergo a dental treatment prior to his entrance to the study. In case of systemic infection, the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.\n* ASA type \\> II\n* Current pregnancy or breastfeeding women\n* Alcoholism or chronically drug abuse\n* Smokers, ≳ 10 cigarettes per day\n* Immunocompromised patients\n* Uncontrolled diabetes\n* Untreated periodontitis\n* History of previous periodontal surgery (mucogingival or other) on the teeth to be included\n* Presence of severe tooth malposition, rotation or significant version of the tooth to be treated'}, 'identificationModule': {'nctId': 'NCT05747092', 'briefTitle': 'Pain Killer, Anxiety and Mucogingival Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Is Pain Killer Cunsumption Dependent to Anxiety or Mucogingival Therapy?', 'orgStudyIdInfo': {'id': 'B7072021000061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group: free gingival graft for gingival recession', 'interventionNames': ['Procedure: gingival graft']}, {'type': 'EXPERIMENTAL', 'label': 'Test group: connective tissue graft for gingival recession', 'interventionNames': ['Procedure: gingival graft']}], 'interventions': [{'name': 'gingival graft', 'type': 'PROCEDURE', 'description': 'investigators:\n\nDonor site:\n\n* tissue graft harvesting from the palate behind the palatal rugae .\n* placement of a palatine hemostatic plaque on the palate in order to reduce the risk of bleeding and to diminish the postoperative pain.\n\nReceived site:\n\n* Control: the horizontal incision adjacent to the recession(s) and vertical incisions and split thickness flap. Placement of the graft on the recipient bed and suture.\n* Test :connective tissue graft using the " envelope/pouch " technique with two partial thickness incisions (deep and superficial). Placement of the graft inside the envelope', 'armGroupLabels': ['Control group: free gingival graft for gingival recession', 'Test group: connective tissue graft for gingival recession']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'state': 'Liege', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'leila Salhi, PhD', 'role': 'CONTACT', 'email': 'l.salhi@chuliege.be', 'phone': '0484888091'}], 'facility': 'leila Salhi', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'centralContacts': [{'name': 'leila Salhi, PhD', 'role': 'CONTACT', 'email': 'l.salhi@chuliege.be', 'phone': '0484888091'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD,Head of clinic, department of Periodontology, buccal surgery and buccal implantology,', 'investigatorFullName': 'Leila Salhi', 'investigatorAffiliation': 'University of Liege'}}}}