Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 12:33 AM
Study NCT ID:
NCT05485194
Status:
WITHDRAWN
Last Update Posted:
2025-01-24
First Post:
2022-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ridge Preservation Following Tooth Extraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No funding was obtained. Therefore, the study never started.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2022-07-31', 'studyFirstSubmitQcDate': '2022-07-31', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The width of the alveolar bone', 'timeFrame': 'up to 6 months', 'description': 'Dimensional changes in the width of the alveolar bone following tooth extraction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alveolar Bone Resorption', 'Tooth Extraction']}, 'referencesModule': {'references': [{'pmid': '34741321', 'type': 'RESULT', 'citation': 'Joseph S, Oh SL, Pae EK, Joshi S. Use of transcortical miniscrews for alveolar ridge preservation following tooth extraction: A pilot study. Clin Oral Implants Res. 2022 Feb;33(2):150-157. doi: 10.1111/clr.13875. Epub 2021 Nov 16.'}, {'pmid': '25403977', 'type': 'RESULT', 'citation': 'Melsen B, Huja SS, Chien HH, Dalstra M. Alveolar bone preservation subsequent to miniscrew implant placement in a canine model. Orthod Craniofac Res. 2015 May;18(2):77-85. doi: 10.1111/ocr.12058. Epub 2014 Nov 18.'}]}, 'descriptionModule': {'briefSummary': 'An animal study and our pilot human study demonstrated that placing a smooth-surface titanium bone screw (TBS) over the buccal plate of an extraction socket resulted in less dimensional changes of the alveolar ridge along with no adverse effects. The purpose of this randomized clinical trial is to investigate the effectiveness of TBS application for ridge preservation in comparison to (1) unassisted/non-interventional socket healing and (2) alveolar ridge preservation (ARP) approach using allografts and a membrane.', 'detailedDescription': 'The participants will be randomized to one of the three groups: the non-intervention, titanium bone screw (TBS), and alveolar ridge preservation (ARP) groups. The sockets in the non-intervention group will be filled with blood clots only. One TBS will be placed over the labial/buccal plate of the extraction socket in the TBS group on the same day of the extraction. Allograft and resorbable collagen membrane will be used for the ARP group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18 years\n* a tooth, which is in the area from the central incisor to the second premolar bounded by teeth (or implants) mesiodistally\n* a tooth requiring extraction\n\nExclusion Criteria:\n\n* thyroid dysfunctions\n* diabetes mellitus\n* history of a chronic use of corticosteroids (\\>6 months)\n* history of oral/intravenous bisphosphonates within the past 2 years\n* smoking\n* history of other systemic conditions that could affect bone integrity.'}, 'identificationModule': {'nctId': 'NCT05485194', 'briefTitle': 'Ridge Preservation Following Tooth Extraction', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Use of a Titanium Bone Screw for Ridge Preservation Following Tooth Extraction', 'orgStudyIdInfo': {'id': 'HP-00102697'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Unassisted healing', 'description': 'The extraction sockets in the non-intervention group will be filled with blood clots only.'}, {'type': 'EXPERIMENTAL', 'label': 'Titanium bone screw (TBS)', 'description': 'One titanium bone screw (TBS) will be placed over the labial/buccal plate of the extraction socket in the TBS group on the same day of the extraction.', 'interventionNames': ['Other: Reducing dimensional changes following tooth extraction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alveolar ridge preservation (ARP)', 'description': 'The extraction socket will be filled with mineralized ground cortical allograft up to the level of the buccal and lingual/palatal bony plates. A resorbable membrane will be trimmed and adapted to cover the grafting material. The flaps will be secured with a monofilament suture.', 'interventionNames': ['Other: Reducing dimensional changes following tooth extraction']}], 'interventions': [{'name': 'Reducing dimensional changes following tooth extraction', 'type': 'OTHER', 'description': 'Use of a titanium bone screw for ridge preservation following tooth extraction', 'armGroupLabels': ['Alveolar ridge preservation (ARP)', 'Titanium bone screw (TBS)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Se-Lim Oh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland School of Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shares with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Se-Lim Oh', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}