Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:31 PM
Study NCT ID:
NCT07280260
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Performance of Nobel N1 System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016388', 'term': 'Tooth Loss'}, {'id': 'D009066', 'term': 'Mouth, Edentulous'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study is a two-arm, randomized prospective clinical trial. The randomization of the patients will be done after implant has been placed and if sufficient torque was obtained as outlined previously. At this point, using a computer generated table of random numbers, patients will be randomized into early loading and delayed loading group. Since it is not possible to predict ahead of time what the final torque will be at implant placement, a third group will comprise patients that receive implants that have lower torque that cannot be randomized. These patients will follow traditional one stage or two stage protocol for implant placement and delayed protocol. Irrespective of randomization and torque status and implant placement, all patients will be followed up as part of the study and analyzed based on the group to which they belong.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-12-11', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant survival', 'timeFrame': '6 months, 1 year', 'description': 'Implant survival will be measured if it is not failed and still present at time points'}, {'measure': 'Misch implant success criteria', 'timeFrame': '6 months, 1 year', 'description': 'Implant success will be measured according to Misch et al.'}], 'secondaryOutcomes': [{'measure': 'Marginal bone loss', 'timeFrame': '6 months, 1 year', 'description': 'Marginal bone loss from the platform of the implant will be measured on Peri-apical X-rays and bitewings'}, {'measure': 'Probing depth', 'timeFrame': '6 months, 1 year', 'description': 'Probing depths will be measured at 6 surfaces'}, {'measure': 'Presence of sulcular suppuration on gentle probing', 'timeFrame': '6 months, 1 year', 'description': 'Presence or absence of suppuration will be evaluated upon gentle probing at 6 surfaces around the implant'}, {'measure': 'Presence of sulcular bleeding on gentle probing', 'timeFrame': '6 months, 1 year', 'description': 'Presence or absence of bleeding will be evaluated upon gentle probing at 6 surfaces around the implant'}, {'measure': 'Peri-implant Mucosal Tissue Index', 'timeFrame': 'Prosthetic delivery, 6 months, 1 year'}, {'measure': 'Patient satisfaction questionnaire', 'timeFrame': 'Prosthetic delivery, 6 months, 1 year'}, {'measure': 'Prosthetic complications', 'timeFrame': '6 months, 1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Tooth loss', 'Edentulous', 'Dental implants'], 'conditions': ['Tooth Loss', 'Dental Implant']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate whether N1 dental implants are successful when a final crown is placed on them at 6 weeks from implant placement surgery.', 'detailedDescription': 'This study aims to evaluate the survival and stability of the Nobel N1 dental implant and its accompanying crown over a one-year period when the crown is placed either 6 or 12 weeks after implant placement. The Nobel N1 implant is an FDA-approved, newly designed implant featuring an innovative surgical placement protocol intended to minimize bone trauma, promote faster integration, and potentially allow for the placement of final crowns earlier-at 6 weeks instead of the traditional 4 to 5 months. This study will enroll adult participants who are missing a single tooth in the back of the mouth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females, age 18 or older\n\n * Can provide an Informed Consent in English.\n * Absence of a single posterior tooth in mandible or maxilla with presence of natural neighboring teeth (except for second molar which only requires presence of first molar)\n * Presence of antagonist teeth\n * Possibility and will for an immediate restoration.\n * Systemic health recorded as an American Society of Anesthesiologists (ASA) I or II\n\nExclusion Criteria:\n\n* · Unavailability to attend the follow-up visits.\n\n * A systemic contraindication for oral surgical procedures; ASA III or IV.\n * Pregnancy or nursing on screening or before the surgical procedure.\n * Diseases that could alter healing or bone metabolism (uncontrolled diabetes, diagnostic osteoporosis, etc.),\n * Taking medications that are altering healing or bone metabolism (bisphosphonates, long-time corticosteroids intake, RANK inhibitors, etc.)\n * Alcohol or drug abuse.\n * Current heavy smoking behavior (≥10 cigarettes/day).\n * Radiation therapy to the head or neck region.\n * Pathology in the implant planned sites that prevent implant placement.\n * Current diagnosis of Diabetes, which is uncontrolled (\\>7 HbA1C).\n * Need for sinus lift or vertical bone augmentation\n * Previously failed implant site'}, 'identificationModule': {'nctId': 'NCT07280260', 'briefTitle': 'Clinical Performance of Nobel N1 System', 'organization': {'class': 'OTHER', 'fullName': 'Louisiana State University Health Sciences Center in New Orleans'}, 'officialTitle': 'Effects of Early Loading Protocol on the Survival of the Nobel N1 Implant System: A Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '8328'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Early loading', 'description': 'Delivery of the final crowns 6 weeks after the implant placement.', 'interventionNames': ['Device: Nobel N1 implant']}, {'type': 'OTHER', 'label': 'Delayed loading', 'description': 'Delivery of the final crowns 12 weeks after the implant placement.', 'interventionNames': ['Device: Nobel N1 implant']}], 'interventions': [{'name': 'Nobel N1 implant', 'type': 'DEVICE', 'description': 'A Nobel N1 implant will be placed and restored with a On 1 base', 'armGroupLabels': ['Delayed loading', 'Early loading']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70119', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amir Nejat', 'role': 'CONTACT', 'email': 'anejat@lsuhsc.edu', 'phone': '504-981-8283'}, {'name': 'Jeanne St Germain', 'role': 'CONTACT', 'email': 'jstge1@lsuhsc.edu', 'phone': '504-941-8276'}], 'facility': 'LSU School of Dentistry', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'centralContacts': [{'name': 'Amir Nejat', 'role': 'CONTACT', 'email': 'anejat@lsuhsc.edu', 'phone': '504-981-8283'}, {'name': 'Jeanne St Germain', 'role': 'CONTACT', 'email': 'jstge1@lsuhsc.edu', 'phone': '504-941-8276'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Louisiana State University Health Sciences Center in New Orleans', 'class': 'OTHER'}, 'collaborators': [{'name': 'Envista (Nobel Biocare)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}