Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT05838651
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-03
First Post:
2023-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Socket Preservation With BioHorizon's Striate+ Membrane and MinerOss X Plug
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-25', 'size': 356849, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-04T17:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Control Clinical Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-02', 'studyFirstSubmitDate': '2023-04-20', 'studyFirstSubmitQcDate': '2023-04-20', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'radiographic ridge width', 'timeFrame': '12 months', 'description': 'To provide detailed evidence of new bone formation in patients undergoing socket preservation procedures.'}], 'secondaryOutcomes': [{'measure': 'gingival thickness', 'timeFrame': '12 months', 'description': 'To assess soft tissue changes.'}, {'measure': 'radiographic alveolar height', 'timeFrame': '12 months', 'description': 'To assess radiographic hard tissue changes.'}, {'measure': 'clinical alveolar height and width', 'timeFrame': '12 months', 'description': 'To assess clinical hard tissue changes.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Bone Graft', 'Membrane', 'Extraction'], 'conditions': ['Socket Preservation']}, 'descriptionModule': {'briefSummary': 'The primary objective of this proposed clinical trial is to provide detailed comparison and evidence of new bone formation in patients undergoing socket preservation utilizing MinerOss® X Plug with and without Striate+ Membrane to maintain ridge dimension after a tooth extraction.', 'detailedDescription': 'The primary objective of this proposed clinical trial is to provide detailed comparison and evidence of new bone formation in patients undergoing socket preservation utilizing two widely accepted treatment modalities that are used to maintain ridge dimension after a tooth extraction.\n\nThe specific aims of the study are:\n\n1. To demonstrate the efficacy of a Striate+ membrane in conjunction with a bone graft substitute for providing hard tissue regeneration in the socket preservation procedure.\n2. To determine the safety of Striate+ membrane when primary flap closure over the membrane is not achieved in the socket preservation procedure.\n3. To provide detailed evidence of new bone formation in patients undergoing socket preservation procedures by means of clinical, radiographic, histologic, and histomorphometric analyses.\n\nIt is currently unclear if one treatment is more effective than the other. The two treatments being compared are:\n\nTreatment 1: Socket preservation sites with bone graft (MinerOss® X Plug) alone without complete flap closure (secondary intention healing) (n=10) Treatment 2: Socket preservation sites with bone graft (MinerOss® X Plug) and a non-crosslinked collagen membrane without complete flap closure (secondary intention healing) (n=10)\n\nMinerOss® X Plug: A xenograft composed of 80% bovine cancellous particulate and 20% bovine Type I collagen. The 20% collagen prevents particulate migration.\n\nStriate+ Membrane: A non-crosslinked collagen covering used to keep bacteria out and hold the bone graft in place.\n\nSecondary intention healing (without complete flap closure): The wound edges are not brought together (i.e. knee scrape).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, between 20-70 years of age, who requests dental implant treatment option for rehabilitation.\n* Subjects who are willing to sign an informed consent, participate and return for follow-up visits.\n* Subjects without significant medical history and currently not on medications that might complicate our results.\n* Has a single-rooted tooth (upper and lower premolars to premolars) requiring extraction with two neighboring teeth on either side of it and intact bony walls.\n\nExclusion Criteria:\n\n* Subjects who do not meet all the inclusion criteria or who will not cooperate with the protocol schedule.\n* Subjects who received and failed a previously placed dental implant.\n* Subjects who require additional ridge augmentation procedure in the area to achieve adequate bone volume for the placement of dental implants.\n* Subjects who have significant untreated periodontal disease, caries, infection or chronic inflammation in the oral cavity within two adjacent tooth positions of the clinical trial area.\n* Subjects who have used nicotine-containing products within 3 weeks prior to surgery.\n* Subjects who are insulin-dependent diabetic or if their Hgb1c levels \\> 6.5%.\n* Subjects who have had a history of malignancy within the past 5 years (except for basal or squamous cell carcinoma of the skin or in situ cervical carcinoma).\n* Subjects who are nursing or pregnant.\n* Subjects who are presently taking medications (except estrogen/progesterone therapy) or those who are undergoing treatment that in known to have an effect on bone turnover.\n* Subjects who have diseases that affect bone metabolism (excluding idiopathic osteoporosis).\n* Subjects with a history of an autoimmune disease, documented allergy or multiple allergies to any component of the agents used in this study.\n* Difficult extraction with potential disruption / fracture of the alveolar bone.\n* Acutely infected defect site.\n* Subjects who are presently taking blood thinner medications.'}, 'identificationModule': {'nctId': 'NCT05838651', 'briefTitle': "Socket Preservation With BioHorizon's Striate+ Membrane and MinerOss X Plug", 'organization': {'class': 'OTHER', 'fullName': 'Harvard School of Dental Medicine'}, 'officialTitle': "The Combination of BioHorizon's Striate+ Membrane in Conjunction With MinerOss X Plug for Providing Hard Tissue Regeneration in Socket Preservation Procedure", 'orgStudyIdInfo': {'id': 'IRB23-0179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bone Graft Alone', 'description': 'Socket preservation sites with bone graft (MinerOss® X Plug) alone without complete flap closure (secondary intention healing) (n=10)', 'interventionNames': ['Device: MinerOss® X Plug']}, {'type': 'EXPERIMENTAL', 'label': 'Bone Graft + Membrane', 'description': 'Socket preservation sites with bone graft (MinerOss® X Plug) and a non-crosslinked collagen membrane without complete flap closure (secondary intention healing) (n=10)', 'interventionNames': ['Device: MinerOss® X Plug', 'Device: Striate+ Membrane']}], 'interventions': [{'name': 'MinerOss® X Plug', 'type': 'DEVICE', 'description': 'A xenograft composed of 80% bovine cancellous particulate and 20% bovine Type I collagen.', 'armGroupLabels': ['Bone Graft + Membrane', 'Bone Graft Alone']}, {'name': 'Striate+ Membrane', 'type': 'DEVICE', 'description': 'A non-crosslinked collagen covering used to keep bacteria out and hold the bone graft in place.', 'armGroupLabels': ['Bone Graft + Membrane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Harvard School of Dental Medicine', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'David M Kim, DDS, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Dental Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard School of Dental Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Camlog Oral Reconstruction Foundation', 'class': 'OTHER'}, {'name': 'BioHorizons, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Department of Oral Medicine, Infection, and Immunity', 'investigatorFullName': 'Chia-Yu Chen', 'investigatorAffiliation': 'Harvard School of Dental Medicine'}}}}