Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT06435832
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluations of the Effects of Tranexamic Acid and Chlorhexidine Gel on Alveolar Osteitis Incidence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004368', 'term': 'Dry Socket'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005781', 'term': 'Gelatin Sponge, Absorbable'}, {'id': 'D002710', 'term': 'Chlorhexidine'}, {'id': 'D014148', 'term': 'Tranexamic Acid'}], 'ancestors': [{'id': 'D015503', 'term': 'Surgical Sponges'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-24', 'studyFirstSubmitDate': '2024-05-20', 'studyFirstSubmitQcDate': '2024-05-24', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain', 'timeFrame': '3.-7. days', 'description': 'scored on visual analog scale from 0 to 10'}, {'measure': 'edema', 'timeFrame': '3. day - 7. day', 'description': 'scored on visual analog scale from 0 to 10'}, {'measure': 'trismus', 'timeFrame': '3. day - 7. day', 'description': 'marked yes or no based on clinical examination'}, {'measure': 'halitosis', 'timeFrame': '3. day - 7. day', 'description': 'marked yes or no based on clinical examination'}, {'measure': 'alveolar osteitis', 'timeFrame': '3. day - 7. day', 'description': 'marked yes or no based on clinical examination'}, {'measure': 'smoking habit', 'timeFrame': 'operated day', 'description': 'marked yes or no based on anamnesis'}, {'measure': 'age', 'timeFrame': 'operated day', 'description': 'marked yes or no based on anamnesis'}, {'measure': 'tooth type', 'timeFrame': 'operated day', 'description': 'marked yes or no based on clinical examination'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alveolar Osteitis'], 'conditions': ['Alveolar Osteitis']}, 'referencesModule': {'references': [{'pmid': '39167305', 'type': 'DERIVED', 'citation': 'Gumrukcu Z, Karabag M, Guven SE. The effects of chlorhexidine gel and tranexamic acid application after tooth extraction on the risk of alveolar osteitis formation: a double blind clinical study. Clin Oral Investig. 2024 Aug 21;28(9):494. doi: 10.1007/s00784-024-05886-x.'}]}, 'descriptionModule': {'briefSummary': 'This intervention is the treatment of alveolar osteitis (alveolitis) with different effects, which occurs due to the formation of clot after extraction, which is one of the most common intervals after tooth extraction.98 healthy patients with molar and premolar teeth with indication for extraction were taken to the Recep Tayyip Erdoğan University Faculty of Dentistry, Department of Oral and Maxillofacial Diseases and Surgery clinic between May 2024 and June 2024 (age: 38 sessions: 19). -62) 113 teeth (85 molar, 28 premolar teeth) were treated with Spongostan placed in the tooth socket after extraction, spongostan with Chlorhexidine gel and spongostan with tranexamic acid, randomly distributed. After extraction, alveolitis was observed and evaluated prospectively using spongostan, chlorhexidine gel and tranexamic acid in the dental sockets. The researcher checked the participants on the 3rd and 7th days after the tooth extraction. The researcher recorded the pain and edema levels by asking the participants between 0 and 10 using the Visual Analogue Scale (VAS). The researcher filled in the forms for the presence of halitosis, trismus and exposed bone socket on the 3rd and 7th days (YES-NO). Permanent analyzes of the study were created with the SPSS package program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy individuals between the ages of 18-65\n2. Molar and premolar teeth with extraction indication\n\nExclusion Criteria:\n\n1. Against drugs or substances to be used in surgery (articaine, tranexamic acid, chlorhexidine) have allergies,\n2. Those who used antibiotics 30 days before the dental extraction,\n3. Clinical and radiological examinations in the operation area 30 days before dental extraction and/or on the day of the procedure.\n\n Any signs of pathology and infection (such as periapical pathology, pericoronitis),\n4. Those who routinely use oral antiseptics,\n5. Systemic fever, absence of growth such as lymphadenopathy (LAP),\n6. Women are lactating or pregnant,\n7. Using oral contraceptives,\n8. Procedures that were not attended to control appointments (day 3-7) were not included.'}, 'identificationModule': {'nctId': 'NCT06435832', 'briefTitle': 'Evaluations of the Effects of Tranexamic Acid and Chlorhexidine Gel on Alveolar Osteitis Incidence', 'organization': {'class': 'OTHER', 'fullName': 'Recep Tayyip Erdogan University'}, 'officialTitle': 'Evaluation of the Effects of Tranexamic Acid and Chlorhexidine Gel on Alveolar Osteitis Incidence', 'orgStudyIdInfo': {'id': 'RTEUni'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'just absorbable gelatin', 'description': 'After tooth extraction, only saline irrigation was applied and a absorbable gelatin sponge was placed in the socket.', 'interventionNames': ['Drug: Absorbable Gelatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'absorbable gelatin with Chlorhexidine gel', 'description': 'After tooth extraction, after irrigation with saline, 2% chlorhexidine gel was absorbed into gelatin sponges and placed into the socket.', 'interventionNames': ['Drug: Chlorhexidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'absorbable gelatin with tranexamic acid', 'description': 'Tranexamic acid 50mg/ml for injection after saline irrigation after tooth extraction solution into gelatin sponges was applied to the socket after it was cured.', 'interventionNames': ['Drug: Tranexamic acid']}], 'interventions': [{'name': 'Absorbable Gelatin', 'type': 'DRUG', 'description': 'After tooth extraction, only saline irrigation was applied and a absorbable gelatin sponge was placed in the socket.', 'armGroupLabels': ['just absorbable gelatin']}, {'name': 'Chlorhexidine', 'type': 'DRUG', 'description': 'After tooth extraction, after irrigation with saline, 2% chlorhexidine gel was absorbed into gelatin sponges and placed into the socket.', 'armGroupLabels': ['absorbable gelatin with Chlorhexidine gel']}, {'name': 'Tranexamic acid', 'type': 'DRUG', 'description': 'Tranexamic acid 50mg/ml for injection after saline irrigation after tooth extraction solution into gelatin sponges was applied to the socket after it was cured.', 'armGroupLabels': ['absorbable gelatin with tranexamic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53020', 'city': 'Rize', 'country': 'Turkey (Türkiye)', 'facility': 'Recep Tayyip Erdoğan University', 'geoPoint': {'lat': 41.02083, 'lon': 40.52194}}], 'overallOfficials': [{'name': 'Zeynep Gümrükçü', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Recep Tayyip Erdogan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Recep Tayyip Erdogan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Zeynep Gumrukcu', 'investigatorAffiliation': 'Recep Tayyip Erdogan University'}}}}