Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT07271134
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short-term Observation on the Clinical Application Effect of Astra Tech Implant EV Short Implants for Maxillary Sinus Elevation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000848', 'term': 'Anodontia'}], 'ancestors': [{'id': 'D014071', 'term': 'Tooth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-11-22', 'studyFirstSubmitQcDate': '2025-12-06', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': 'From having a tooth implant to one year after wearing the dentures', 'description': 'Very satisfied, satisfied, dissatisfied, the rate of dissatisfaction, etc.'}], 'primaryOutcomes': [{'measure': 'Various complications', 'timeFrame': 'From having a tooth implant to one year after wearing the dentures', 'description': 'the rate of Implant survival, swelling, pain, etc.'}], 'secondaryOutcomes': [{'measure': 'marginal bone resorption', 'timeFrame': 'one year', 'description': 'Measure the changes in the bone height around the implant'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Short implant', 'Maxillary sinus floor elevation'], 'conditions': ['Missing Teeth']}, 'descriptionModule': {'briefSummary': 'Short-term comparison of clinical application effects of Astra OsseoSpeed EV short implants and conventional implants for maxillary sinus elevation', 'detailedDescription': '1. If the survival rate, marginal bone resorption , complications and patient satisfaction of the short implant group are comparable or better than those of the conventional implant group, then short implants can be regarded as an effective treatment option for insufficient alveolar bone in the posterior teeth area. Thus, in clinical practice, the investigators can utilize short implants combined with transcrestal sinus floor elevation, or even implant short implants to help patients with certain insufficient maxillary bone complete implant restoration without resorting to more complex, costly and more invasive external elevation surgery to increase the length of posterior teeth implants in the maxillary region.\n2. If it is found that the short implant group has a higher incidence of complications or a lower long-term survival rate, further exploration of its indications and optimization of surgical strategies is required.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged over 18 years old with at least one area of the posterior dental arch having insufficient alveolar bone height (3-6 mm)\n* Patients are in good health and have no major systemic diseases such as diabetes or cardiovascular diseases, and no maxillary sinus lesions\n* They are willing to undergo implant restoration treatment and can complete at least 3-year follow-up.\n\nExclusion Criteria:\n\n* horizontal bone deficiency alveolar ridges,bone defects caused by tumor resection\n* excessive tobacco use (more than 10 cigarettes per day)\n* severe liver and kidney diseases\n* history of radiotherapy and chemotherapy in the head and neck region\n* uncontrolled diabetes\n* active periodontal disease\n* oral mucosal diseases in the treatment area or poor oral hygiene,\n* PI \\> 70%'}, 'identificationModule': {'nctId': 'NCT07271134', 'briefTitle': 'Short-term Observation on the Clinical Application Effect of Astra Tech Implant EV Short Implants for Maxillary Sinus Elevation', 'organization': {'class': 'OTHER', 'fullName': 'Wuhan Central Hospital'}, 'officialTitle': 'Short-term Observation on the Clinical Application Effect of Astra Tech Implant EV Short Implants for Maxillary Sinus Elevation', 'orgStudyIdInfo': {'id': 'WHZXKYL2025-123'}, 'secondaryIdInfos': [{'id': 'I-AS-25-105', 'type': 'OTHER_GRANT', 'domain': 'DENTSPLY IH AB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'transcrestal sinus floor elevation', 'interventionNames': ['Device: short implants (L=6.3mm)', 'Procedure: short implants (L=8mm)', 'Device: conventional implants (L=9mm)']}], 'interventions': [{'name': 'short implants (L=6.3mm)', 'type': 'DEVICE', 'description': 'Short-term clinical outcome of Astra OsseoSpeed EV short implants (L=6.3mm) for transcrestal sinus floor elevation', 'armGroupLabels': ['transcrestal sinus floor elevation']}, {'name': 'short implants (L=8mm)', 'type': 'PROCEDURE', 'description': 'Short-term clinical outcome of Astra OsseoSpeed EV short implants (L=8mm) for transcrestal sinus floor elevation', 'armGroupLabels': ['transcrestal sinus floor elevation']}, {'name': 'conventional implants (L=9mm)', 'type': 'DEVICE', 'description': 'conventional implants (L=9mm) in the posterior maxillary region for dental restoration', 'armGroupLabels': ['transcrestal sinus floor elevation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '422202', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'contacts': [{'name': "lin hu Wang, Doctor's degree", 'role': 'CONTACT', 'email': '316036445@qq.com', 'phone': '+8618086060633'}], 'facility': "No. 26, Shengli Street, Jiang'an District, Wuhan City, Hubei Province, China", 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'lin hu Wang, Doctoral', 'role': 'CONTACT', 'email': '316036445@qq.com', 'phone': '+8618086060633'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': 'Methods and Results'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linhu Wang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dentsply Sirona Implants and Consumables', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical professor', 'investigatorFullName': 'Linhu Wang', 'investigatorAffiliation': 'Wuhan Central Hospital'}}}}