Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-01-24 @ 7:07 AM
Study NCT ID:
NCT03059108
Status:
COMPLETED
Last Update Posted:
2023-05-23
First Post:
2017-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of B+ Surface on Early Loading
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007576', 'term': 'Jaw, Edentulous, Partially'}], 'ancestors': [{'id': 'D007575', 'term': 'Jaw, Edentulous'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009066', 'term': 'Mouth, Edentulous'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057893', 'term': 'Immediate Dental Implant Loading'}], 'ancestors': [{'id': 'D003758', 'term': 'Dental Implantation, Endosseous'}, {'id': 'D003757', 'term': 'Dental Implantation'}, {'id': 'D013516', 'term': 'Oral Surgical Procedures, Preprosthetic'}, {'id': 'D019647', 'term': 'Oral Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D011476', 'term': 'Prosthodontics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-20', 'studyFirstSubmitDate': '2017-02-12', 'studyFirstSubmitQcDate': '2017-02-15', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical success of B+-treated dental implants after conventional or early loading protocol as described by the International Congress of Oral Implantologists, Pisa Consensus Conference, 2007', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Change in marginal bone level around B+-treated implants after conventional or early loading protocol', 'timeFrame': '0 (Baseline: prosthesis delivery), 3, 6, and 12 months'}, {'measure': 'Change in inflammatory markers in peri-implant crevicular fluid around B+-treated implants after conventional or early loading protocol', 'timeFrame': '-14, 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months'}, {'measure': 'Change in the microbiological profile around B+-treated implants after conventional or early loading protocol', 'timeFrame': '-14 (before impressions), 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Jaw, Edentulous, Partially']}, 'referencesModule': {'references': [{'pmid': '33210771', 'type': 'RESULT', 'citation': 'Galindo-Moreno P, Gutierrez-Garrido L, Lopez-Chaichio L, Guerra-Lorenzo C, Rodriguez-Alvarez R, Padial-Molina M. Crestal bone changes around early vs. conventionally loaded implants with a multi-phosphonate coated surface: A randomized pilot clinical trial. Clin Oral Implants Res. 2021 Jan;32(1):75-87. doi: 10.1111/clr.13681. Epub 2020 Dec 18.'}, {'pmid': '40062725', 'type': 'DERIVED', 'citation': "Galindo-Moreno P, Gutierrez-Garrido L, Duarte J, Robles-Vera I, Martin-Morales N, O'Valle F, Olaechea A, Carrillo-Galvez AB, Padial-Molina M. Evolution in the Peri-Implant Oral Microbiome and Their Relationship to Long-Term Marginal Bone Loss: A Randomized Clinical Study. Clin Oral Implants Res. 2025 Jul;36(7):802-820. doi: 10.1111/clr.14426. Epub 2025 Mar 10."}]}, 'descriptionModule': {'briefSummary': 'The trial is designed as a consecutive enrollment prospective one-center study. A minimum of 30 patients will be included in the study. At implant installation, the implant will be randomized to one of the groups (Control: conventional loading, 8 weeks; Test: early loading, 4 weeks). Samples of peri-implant crevicular fluid (PICF) and intrasulcular plaque will be collected at -14, 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months. Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks after the impressions are taken.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient \\>18 and ≤75 years old\n* One missing tooth in the premolar or molar area with both opposing and adjacent teeth (mesial and distal).\n\nExclusion Criteria:\n\n* One-stage bone augmentation\n* Heavy smokers (\\>10 cigarettes/day)\n* Uncontrolled type 1 or 2 diabetes (HgA1c\\>8)\n* Known auto-immune or inflammatory disease\n* Severe hematologic disorders, such as hemophilia or leukemia\n* Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology)\n* Liver or kidney dysfunction/failure\n* Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy\n* Long-term history of oral bisphosphonates use (i.e., 10 years or more)\n* History of intravenous bisphosphonates\n* Long-term (\\>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system\n* Severe osseous diseases (e.g., Paget disease of bone)\n* Pregnant women or nursing mothers\n* Not able or not willing to follow instructions related to the study procedures'}, 'identificationModule': {'nctId': 'NCT03059108', 'briefTitle': 'Evaluation of B+ Surface on Early Loading', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'Evaluation of B+ Surface on Early Loading', 'orgStudyIdInfo': {'id': '216CEIH2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Loading', 'description': 'Implant early loading: prosthesis delivery 4 weeks after implant placement', 'interventionNames': ['Procedure: Early Loading']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Loading', 'description': 'Implant conventional loading: prosthesis delivery 8 weeks after implant placement', 'interventionNames': ['Procedure: Conventional Loading']}], 'interventions': [{'name': 'Early Loading', 'type': 'PROCEDURE', 'description': 'The procedure in this group will consist on placing implant-supported restorations over the implants placed 4 weeks earlier. The device (dental implant) is of the same type in both groups.', 'armGroupLabels': ['Early Loading']}, {'name': 'Conventional Loading', 'type': 'PROCEDURE', 'description': 'The procedure in this group will consist on placing implant-supported restorations over the implants placed 8 weeks earlier. The device (dental implant) is of the same type in both groups.', 'armGroupLabels': ['Conventional Loading']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18071', 'city': 'Granada', 'country': 'Spain', 'facility': 'Facultad de Odontología', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'overallOfficials': [{'name': 'Pablo Galindo-Moreno, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Granada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pablo Galindo-Moreno', 'investigatorAffiliation': 'Universidad de Granada'}}}}