Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-29 @ 4:57 AM
Study NCT ID:
NCT07027904
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-19
First Post:
2025-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Implant in Posterior Mandible Region
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016254', 'term': 'Mutagenesis, Insertional'}], 'ancestors': [{'id': 'D015202', 'term': 'Protein Engineering'}, {'id': 'D005818', 'term': 'Genetic Engineering'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009154', 'term': 'Mutation'}, {'id': 'D014644', 'term': 'Genetic Variation'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D016296', 'term': 'Mutagenesis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2025-05-19', 'studyFirstSubmitQcDate': '2025-06-17', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant secondary stability', 'timeFrame': '6 months', 'description': 'Method of Measurement (Using the Osstell® Device.) -Unit of Measurement (ISQ)'}], 'secondaryOutcomes': [{'measure': 'width bone', 'timeFrame': 'immediate postoperative and at 6 months', 'description': 'Method of Measurement (Conebeam computed tomography (CBCT) ) -Unit of Measurement (Hounsfield unit)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immediate Implant With Bone Graft']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate implant stability and Width bone after placement of immediate implant and Xenograft mixed with Hyaluronic acid or with Platelet-Rich Fibrin (PRF) at posterior mandible region'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Age ≥ 18 years.\n\n * Both sexes.\n * Cooperative and likely to maintain good dental health.\n * Recent extraction multi roots.\n * There is a bone between (2 or 3) mm at lest from the apex of the root.\n\nExclusion Criteria:\n\n* • Patients who had undergone previous extraction of all badly decayed teeth .\n\n * Implant placement in both healed bone and at the extraction sites in the same procedure.\n * Presence of any local or systemic factors that might contraindicate oral surgery.\n * Poor oral hygiene.\n * Conditions that complicate wound healing such as uncontrolled diabetes, smoking (10 cigarettes a day), pregnancy, a history of drug or alcohol abuse, and an inability or unwillingness to return for follow-ups after occlusal loading.'}, 'identificationModule': {'nctId': 'NCT07027904', 'briefTitle': 'Immediate Implant in Posterior Mandible Region', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Immediate Implant Placement Using Xenograft as Space Filling Material Mixed With Platelet-Rich Fibrin (PRF) Versus Hyaluronic Acid in Posterior Mandible Region', 'orgStudyIdInfo': {'id': 'xenograft with (PRF)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'using xenograft as space filling material mixed with hyaluronic acid', 'description': 'the jumping space will packed using Xenograft (cur oss , Astro star) with particle size ranging from 0.25 to 1 mm and it will be mixed with hyaluronic acid', 'interventionNames': ['Device: Implant']}, {'type': 'EXPERIMENTAL', 'label': 'xenograft (cur oss , Astro star ) mixed with Platelet-Rich Fibrin (PRF)', 'description': 'the jumping space will packed using Xenograft (cur oss , Astro star) with particle size ranging from 0.25 to 1 mm and it will be mixed with Platelet-rich fibrin (PRF)', 'interventionNames': ['Device: Implant']}], 'interventions': [{'name': 'Implant', 'type': 'DEVICE', 'description': 'The immediate implant was placed, and the surrounding cavity was filled with xenograft bone material, along with the application of hyaluronic acid or platelet-rich fibrin (PRF) to enhance healing and bone integration.', 'armGroupLabels': ['using xenograft as space filling material mixed with hyaluronic acid', 'xenograft (cur oss , Astro star ) mixed with Platelet-Rich Fibrin (PRF)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'WASIM HALABI, MSc degree candidate', 'role': 'CONTACT', 'email': 'wasim.halabi@dentistry.cu.edu.eg', 'phone': '+201152922450'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'WASIM MHD JEHAD HALABI', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': "Bachelor's Degree of Oral and Dental Medicine", 'investigatorFullName': 'WASIM MHD JEHAD HALABI', 'investigatorAffiliation': 'Cairo University'}}}}