Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-01-03 @ 1:36 AM
Study NCT ID:
NCT07240493
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BMP Effect on Implant Stability and Marginal Bone Level After Immediate Placement
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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-11-16', 'studyFirstSubmitQcDate': '2025-11-16', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant Stability Quotient (ISQ) measured by Resonance Frequency Analysis', 'timeFrame': 'Baseline and 16 weeks after implant placement', 'description': 'Evaluation of implant stability using resonance frequency analysis (RFA) device to measure the Implant Stability Quotient (ISQ) at baseline and 16 weeks after implant placement.'}], 'secondaryOutcomes': [{'measure': 'Marginal Bone Level (MBL) Changes around Dental Implants', 'timeFrame': 'Baseline and 16 weeks after implant placement', 'description': 'Radiographic assessment of marginal bone level (MBL) around dental implants using Cone Beam Computed Tomography (CBCT) at baseline and 16 weeks after implant placement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Unrestorable Tooth Replaced by Immediate Implant With BMP']}, 'descriptionModule': {'briefSummary': 'This randomized controlled clinical trial aims to evaluate the effect of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) on the stability and marginal bone level of dental implants following immediate placement.\n\npatients requiring extraction of unrestorable tooth in upper incisors or premolar region will be randomly assigned into two groups: the experimental group will receive immediate implant placement with rhBMP-2 application, while the control group will receive immediate implant placement without rhBMP-2.\n\neach group includes 16 immediate implants. Implant stability will be assessed using resonance frequency analysis (RFA) at baseline, and 16 weeks after implant placement. Marginal bone level changes will be evaluated radiographically using cone beam computed tomography (CBCT).\n\nThe study aims to determine whether the use of rhBMP-2 enhances osseointegration and reduces marginal bone loss compared with conventional immediate implant placement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Healthy patients ≥18 years of either sex, having a single or multiple unrestorable maxillary anterior and premolar teeth which are indicated for extraction, where a jumping gap is most likely to form (≥2mm) provides a reliable environment to study the local effects of rhBMP-2 in consistent and replicable conditions.\n\n 2\\. Apical bone ≥ 3mm from the vertical structure showed in x-rays beyond the apex.\n\n 3\\. Patients who are willing to comply the study and agree to provide their consent.\n\n 4\\. Good to fair oral hygiene.\n\nExclusion Criteria:\n\n\\- 1. Active infection or inflammation in implant area. 2. Medically compromised patients such as uncontrolled diabetes, coagulation disorders, immune compromised patient, patient treated with bisphosphate drugs, psychiatric problems, pregnant women, or any medical condition that affect bone healing.\n\n3\\. Clinical evidence of parafunctional habits. 4. Heavy smokers (≥20 cigarettes a day).'}, 'identificationModule': {'nctId': 'NCT07240493', 'briefTitle': 'BMP Effect on Implant Stability and Marginal Bone Level After Immediate Placement', 'organization': {'class': 'OTHER', 'fullName': 'University of Baghdad'}, 'officialTitle': 'Evaluating the Effect of Bone Morphogenetic Protein on Dental Implant Stability and Marginal Bone Level Following Immediate Implant Placement (Randomized Controlled Study)', 'orgStudyIdInfo': {'id': '991124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: rhBMP-2 Group', 'description': 'Immediate dental implant placement with application of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) with bone graft in jumping gap.', 'interventionNames': ['Biological: rhBMP-2 placement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control: standard immediate implant', 'description': 'Standard immediate dental implant placement procedure without application of Bone Morphogenetic Protein.', 'interventionNames': ['Device: conventional immediate implant']}], 'interventions': [{'name': 'rhBMP-2 placement', 'type': 'BIOLOGICAL', 'description': 'rhBMP-2 is mixed with BCP bone graft and placed in the jumping gap after immediate dental implant placement.', 'armGroupLabels': ['Experimental: rhBMP-2 Group']}, {'name': 'conventional immediate implant', 'type': 'DEVICE', 'description': 'Standard immediate dental implant placement procedure without adding of Bone Morphogenetic Protein in the bone graft placed in the jumping gap.', 'armGroupLabels': ['Control: standard immediate implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10001', 'city': 'Baghdad', 'state': 'Baghdad Governorate', 'country': 'Iraq', 'facility': 'University of Baghdad - College of Dentistry', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared because this is an academic clinical study with a limited number of participants, and data will be used only for internal analysis within the University of Baghdad.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aya Adil Saeed', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Aya Adil Saeed', 'investigatorAffiliation': 'University of Baghdad'}}}}