Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-03-02 @ 7:02 PM
Study NCT ID:
NCT04383834
Status:
UNKNOWN
Last Update Posted:
2020-05-12
First Post:
2020-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 3-YEAR CLINICAL INVESTIGATION ON THE NOBEL ACTIVE® TIULTRA™ IMPLANT AND ON1™ BASE XEAL1™ _____________________________________________________________
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-08-31', 'releaseDate': '2022-10-18'}], 'estimatedResultsFirstSubmitDate': '2022-10-18'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}, 'targetDuration': '47 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-07', 'studyFirstSubmitDate': '2020-05-07', 'studyFirstSubmitQcDate': '2020-05-07', 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A 3-years Investigator initiated study to evaluate the soft tissue health and stability in the mandible and/or maxilla using the NobelActive® TiUltra™ and On1™ Base/Xeal™', 'timeFrame': '47 months (8 months enrolment + 36 months follow up + 3 months study closure)', 'description': 'Soft tissue thickness, using IOS, between implant insertion (baseline) and 3-year follow-up has no changes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['to Study Soft Tissue Health and Stability']}, 'descriptionModule': {'briefSummary': 'Soft tissue thickness, using IOS, between implant insertion (baseline) and 3-year follow-up has no changes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects, at least 18 years old, in need of one single restoration in the posterior region of the maxilla and/or the mandible.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n.The subject inclusion criteria are listed below. The subject is at least 18 years of age (or age of consent) and has passed cessation of growth.\n\nObtained informed consent from the subject. The patient is willing and able to comply with all study related procedures (such as exercising oral hygiene and attending all follow-up procedures).\n\nThe subject shall be healthy and compliant with good oral hygiene. Full-mouth bleeding score (FMBS) lower than 25 %\\[10\\]. Full-mouth plaque score (FMPI) lower than 20% \\[11\\]. Suitable for implant treatment in the posterior, pre-molar area in the mandible or maxilla.\n\nThe subject shall have a favorable and stable occlusal relationship. In need of one single tooth replacement Healed sites in need for implant placement (i.e. minimum of 6 weeks post extraction).\n\nThe implant sites are free from infection and extraction remnants. The subject is suitable for a 1-stage surgical procedure. Sufficient amount of buccal and lingual keratinized mucosa. The healed sites eligible will have natural teeth as neighboring structures. The subject is in such a physical and mental condition that a 3-year follow up period can be carried out without foreseeable problems.\n\nThe subject has a sufficient amount of bone for placing NobelActive TiUltra with a length of at least 7 mm.\n\nThe following subject inclusion criteria apply at time of surgery:\n\nPrimary implant stability as assessed by manual hand testing.\n\nExclusion Criteria:\n\n* The subject is not able to give her/his informed consent of participating. Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure.\n\nReason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or in subject history.\n\nAny disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area.\n\nInfections in the planned implantation site or adjacent tissue. Acute, untreated periodontitis in the planned implantation site or adjacent tissue.\n\nAny ongoing application of interfering medication (steroid therapy, bisphosphonate, etc.).\n\nUncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake or A1c level above 8%.\n\nAlcohol or drug abuse as noted in subject records or in subject history. Smoking less 10 cigarettes/day. Fresh extraction sites (up to 6 weeks). Severe bruxism or other destructive habits. Pregnant or lactating women at the time of implant insertion. Previous bone augmentation (lateral and/or vertical). Soft tissue augmentation less than 2 months before implant placement. Subject has allergic or adverse reactions to the restorative material"}, 'identificationModule': {'nctId': 'NCT04383834', 'briefTitle': 'A 3-YEAR CLINICAL INVESTIGATION ON THE NOBEL ACTIVE® TIULTRA™ IMPLANT AND ON1™ BASE XEAL1™ _____________________________________________________________', 'organization': {'class': 'NETWORK', 'fullName': 'Studio Ban Mancini Fabbri'}, 'officialTitle': '2017-1538: A 3-years Investigator Initiated Study to Evaluate the Soft Tissue Health and Stability in the Mandible and/or Maxilla Using the NobelActive® TiUltra™ and On1™ Base/Xeal™', 'orgStudyIdInfo': {'id': '2017-1538'}}, 'armsInterventionsModule': {'interventions': [{'name': 'NobelActive® TiUltra™ implants and On1™ Base/Xeal™ along with On1 components', 'type': 'DEVICE', 'description': 'The NobelActive® TiUltra™ implant is an ultra-hydrophilic multi-zone anodized implant surface. NobelActive® TiUltra™ features a gradual change in topography, from a minimally rough non-porous nanostructured implant collar to a moderately rough porous apex: more than roughness. NobelActive® TiUltra™ collar features surface chemistry and topography that promote early osseointegration and are designed to support bone stability. In addition, the Protective Layer preserves the pristine surface chemistry and hydrophilicity.\n\nThe second new product is the Base/Xeal™ new surface, which is covered by a titanium oxide layer, created by electrochemical anodization of a titanium machined component, resulting in a yellow hue nano-structured surface.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '47841', 'city': 'Cattolica', 'state': 'Rimini', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giacomo Fabbri, Dentista', 'role': 'CONTACT', 'email': 'info@bmf.dental', 'phone': '3473167583'}], 'facility': 'Studio Ban Mancini Fabbri', 'geoPoint': {'lat': 43.96182, 'lon': 12.73631}}], 'centralContacts': [{'name': 'Giacomo Fabbri, Dentist', 'role': 'CONTACT', 'email': 'info@bmf.dental', 'phone': '0039541963434'}, {'name': 'emanuela fontanarosa', 'role': 'CONTACT', 'email': 'info@bmf.dental', 'phone': '0039541963434'}], 'overallOfficials': [{'name': 'Giacomo Fabbri, Dentist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Studio Ban Mancini Fabbri'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Giacomo Fabbri', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Giacomo Fabbri', 'investigatorFullName': 'Giacomo Fabbri', 'investigatorAffiliation': 'Studio Ban Mancini Fabbri'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-10-18', 'type': 'RELEASE'}, {'date': '2023-08-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Giacomo Fabbri, Principle Investigator, Studio Ban Mancini Fabbri'}}}}