Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-01 @ 2:39 AM
Study NCT ID:
NCT04366635
Status:
UNKNOWN
Last Update Posted:
2020-05-06
First Post:
2020-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Two Different Grafting Techniques After Mandibular Impacted Third Molar Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010514', 'term': 'Periodontal Pocket'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-04', 'studyFirstSubmitDate': '2020-04-26', 'studyFirstSubmitQcDate': '2020-04-26', 'lastUpdatePostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Periodontal pocket depth', 'timeFrame': 'At 0 day', 'description': 'Initial periodontal pocket depth measurement at the distal aspect of second molar tooth before extraction.'}, {'measure': 'Alveolar bone level', 'timeFrame': 'At 0 day', 'description': 'Initial bone level measurement at the distal aspect of second molar tooth before extraction.'}], 'secondaryOutcomes': [{'measure': 'Periodontal pocket depth', 'timeFrame': 'At 6th month', 'description': 'Secondary measurement of periodontal pocket depth after extraction'}, {'measure': 'Alveolar bone level', 'timeFrame': 'At 6th month', 'description': 'Secondary measurement of bone level after extraction'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mineralized Plasmatic Matrix, Beta-tricalcium phosphate'], 'conditions': ['Periodontal Pocket', 'Impacted Third Molar Tooth', 'Impacted Teeth With Abnormal Position']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness of using Mineralized Plasmatic Matrix and β-tricalcium phosphate that placed to extraction socket as a graft material in terms of periodontal damage occurred in the distal aspect of the second molar after mandibular impacted third molar surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Medically healthy.\n* Periodontally healthy patients.\n* Patients with mesioangular or horizontal impacted teeth that will cause periodontal damage at the distal part of the second molar after surgery.\n\nExclusion Criteria:\n\n* Crowns on second molar teeth.\n* Poor oral hygiene.\n* Patients with a systemic disease affecting periodontal healing.\n* Pregnancy or lactation period.\n* Patients undergoing orthodontic treatment.\n* Smokers.\n* The cases where the buccal or lingual cortical bone didn't remain intact following the extraction were also excluded."}, 'identificationModule': {'nctId': 'NCT04366635', 'briefTitle': 'Evaluation of Two Different Grafting Techniques After Mandibular Impacted Third Molar Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Konya Necmettin Erbakan Üniversitesi'}, 'officialTitle': 'Evaluation of the Effectiveness of the Mineralized Plasmatic Matrix and Tricalcium Phosphate Graft Application After Mandibular Impacted Third Molar Surgery in Terms of Periodontal and Osseous Healing Distal to the Second Molar', 'orgStudyIdInfo': {'id': 'KonyaNEU1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mineralised Plasmatic Matrix Group', 'description': 'Mineralized Plasmatic Matrix (MPM) is a product of mixing of two phases: the mineral phase and the plasma phase. After centrifugation, the white blood cells are recovered and mixed with the mineral phase of bone graft that can be autogenic, allogeneic bone, or a bone substitute like Xenogeneic Bone Synthetic. We will use Beta-tricalcium phosphate as a graft material. The result of this mixture is a homogeneous single component, which is compact and stable, containing the graft, the dense fibrin network, and the promoting healing. And then we are planning to place MPM material to extraction socket of impacted third molar tooth to improve periodontal healing at the distal aspect of second molar tooth. Additional after MPM places to extraction socket, Once the MPM has been placed, it will be covered with a Platelet Rich Fibrin (PRF) membrane and sutured as a primer.', 'interventionNames': ['Procedure: Impacted third molar surgery', 'Procedure: Application of mineralised plasmatic matrix']}, {'type': 'EXPERIMENTAL', 'label': 'Beta-tricalcium phosphate Group', 'description': 'Beta-tricalcium phosphate graft will place in the extraction socket and cover with a PRF membrane.', 'interventionNames': ['Procedure: Impacted third molar surgery', 'Procedure: Application of β-tricalcium phosphate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'In the control group, after removal of impacted third molar tooth no material will be placed on the extraction socket. Only the extraction socket was primarily closed with non-resorbable sutures.', 'interventionNames': ['Procedure: Impacted third molar surgery']}], 'interventions': [{'name': 'Impacted third molar surgery', 'type': 'PROCEDURE', 'description': 'Under local anesthesia, flap will be raised and mesioangular or horizontal impacted third molar tooth will be removed with routine technique. And then extraction socket will be irrigated with salin and will be primarily closed.', 'armGroupLabels': ['Beta-tricalcium phosphate Group', 'Control Group', 'Mineralised Plasmatic Matrix Group']}, {'name': 'Application of mineralised plasmatic matrix', 'type': 'PROCEDURE', 'otherNames': ['Application platelet rich fibrin membrane'], 'description': 'After extraction of impacted third molar tooth, Mineralized Plasmatic Matrix will be placed to the socket as a graft material and will be covered with Platelet Rich Fibrin membrane. Then wound will be primarily closed.', 'armGroupLabels': ['Mineralised Plasmatic Matrix Group']}, {'name': 'Application of β-tricalcium phosphate', 'type': 'PROCEDURE', 'otherNames': ['Application platelet rich fibrin membrane'], 'description': 'After extraction of impacted third molar tooth, β-tricalcium phosphate will be placed to the socket as a graft material and will be covered with Platelet Rich Fibrin membrane. Then wound will be primarily closed.', 'armGroupLabels': ['Beta-tricalcium phosphate Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Konya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Kubilay Işık', 'role': 'CONTACT'}], 'facility': 'Necmettin Erbakan University, Faculty of dentistry', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'centralContacts': [{'name': 'Ali Kılınç', 'role': 'CONTACT', 'email': 'dtalikilinc@gmail.com', 'phone': '03322230025'}, {'name': 'Kubilay Işık', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Kubilay Işık', 'role': 'STUDY_CHAIR', 'affiliation': 'Consultant'}, {'name': 'Ali Kılınç', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Care Provider'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konya Necmettin Erbakan Üniversitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Ali Kılınç', 'investigatorAffiliation': 'Konya Necmettin Erbakan Üniversitesi'}}}}