Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT03543618
Status:
UNKNOWN
Last Update Posted:
2018-06-01
First Post:
2018-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Dental Implant Placement in the Sloped Alveolar Ridge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-31', 'studyFirstSubmitDate': '2018-03-20', 'studyFirstSubmitQcDate': '2018-05-31', 'lastUpdatePostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical assessment of the status of osseointegration', 'timeFrame': 'up to 3 years', 'description': 'radiographic bone level, bone consolidation index (ISQ)'}], 'secondaryOutcomes': [{'measure': 'The health status of adjacent teeth', 'timeFrame': '0 day, 6 months, 1 year, 2 years, 3 years', 'description': 'radiographic bone level, clinical attachment level, pocket depth, periodontal bleeding (bleeding on probing), keratinized gingival width (masticatory mucosa width)'}, {'measure': 'The peri-implant health', 'timeFrame': '1 year, 2 years, 3 years', 'description': 'radiographic bone level, clinical attachment level, pocket depth, periodontal bleeding (bleeding on probing), keratinized gingival width (masticatory mucosa width)'}, {'measure': 'Biomarkers in the gingival crevicular fluid of adjacent teeth', 'timeFrame': '0 day, 6 months, 1 year, 2 years, 3 years', 'description': 'Inflammatory markers such as Interleukin-1 beta, matrix metalloproteinase-8, Interleukin-8, or Interleukin-10'}, {'measure': 'Biomarkers in the gingival crevicular fluid of dental implant', 'timeFrame': '1 year, 2 years, 3 years', 'description': 'Inflammatory markers such as Interleukin-1 beta, matrix metalloproteinase-8, Interleukin-8, or Interleukin-10'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dental implant', 'edentulous ridge'], 'conditions': ['Atrophy of Edentulous Alveolar Ridge']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to investigate the therapeutic effect of sloped dental implants. It can reduce the need of osteoectomy, reduce discomfort of procedures, and is easier for maintenance.', 'detailedDescription': '20 OsseoSpeed ™ Profile EV and 20 OsseoSpeed ™ EV groups will be randomly implanted into the oblique edentulous ridges of subjects, and the treatment response will be monitored for 3 years. The implantation area will be randomly divided into two groups, One group was treated with OsseoSpeed ™ Profile EV (sloped group) and the other group was treated with OsseoSpeed ™ EV (control group). The same patient had the same implant as the same quadrant.\n\nThe patient will be followed up regularly for follow-up, followed by clinical attachment level, probing depth, bleeding on probing, keratinized gingival width (Keratinized gingiva), mobility (mobility) and other clinical indicators of the measurement, regular dental radiography, gingival crevicular fluid (GCF) collection and bone integration measurement.\n\nAfter six months of implantation, prosthesis will delivered and loaded functionally, and regular follow-up will be arranged. In each time of follow-up, examination will be carried out with regards to periodontal pocket depth, clinical attachment height, periodontal bleeding index, keratinized gingival width, and other clinical indicators of the measurement, at the end of the experiment, that is, after three years, and then a dental root film irradiation, GCF collection and osseointegration measurement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '20-80 years old with appropriate oral cleaning ability; the computer tomography shows \\> 1 mm buccolingual discrepancy of alveolar ridge height; no generalized periodontitis, or had history of periodontitis but has been completed treatment; no major systemic infection or major systemic illness; not taken antibiotics in the past two weeks Not pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT03543618', 'briefTitle': 'Evaluation of Dental Implant Placement in the Sloped Alveolar Ridge', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Evaluation of Dental Implant Placement in the Sloped Alveolar Ridge', 'orgStudyIdInfo': {'id': '201704081DIPC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Installation of conventional design dental implant', 'interventionNames': ['Device: Control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sloped', 'description': 'Installation of sloped design dental implant', 'interventionNames': ['Device: Sloped']}], 'interventions': [{'name': 'Sloped', 'type': 'DEVICE', 'otherNames': ['"Astra" OsseoSpeedTM Profile EV'], 'description': 'Placement of implant with sloped design', 'armGroupLabels': ['Sloped']}, {'name': 'Control', 'type': 'DEVICE', 'otherNames': ['"Astra" OsseoSpeedTM EV'], 'description': 'Placement of implant with conventional design', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Po-Chun Chang', 'role': 'CONTACT', 'email': 'changpc@ntu.edu.tw', 'phone': '02-23123456', 'phoneExt': '67709'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Po-Chun Chang', 'role': 'CONTACT', 'email': 'changpc@ntu.edu.tw', 'phone': '02-23123456', 'phoneExt': '67709'}, {'name': 'Olivia Hsieh', 'role': 'CONTACT', 'email': 'ling202643@gmail.com', 'phone': '02-23123456', 'phoneExt': '67704'}], 'overallOfficials': [{'name': 'Po-Chun Chang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}