Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-30 @ 3:40 AM
Study NCT ID:
NCT06051266
Status:
UNKNOWN
Last Update Posted:
2023-09-22
First Post:
2023-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of Dynamic Navigation and Static Template in Completely Edentulous Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007575', 'term': 'Jaw, Edentulous'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-20', 'studyFirstSubmitDate': '2023-09-03', 'studyFirstSubmitQcDate': '2023-09-20', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apical deviation of implant placement (mm)', 'timeFrame': 'About 3 days after surgery', 'description': 'Preoperative planning and postoperative cone-beam computed tomography (CBCT) were aligned together in the software and apical deviations(mm) of implant placement were measured to compare the results of the two groups.'}], 'secondaryOutcomes': [{'measure': 'Coronal deviation of implant placement (mm)', 'timeFrame': 'About 3 days after surgery', 'description': 'Preoperative planning and postoperative CBCT were aligned together in the software and coronal deviations(mm) of implant placement were measured to compare the results of the two groups.'}, {'measure': 'Angular deviation of implant placement (°)', 'timeFrame': 'About 3 days after surgery', 'description': 'Preoperative planning and postoperative CBCT were aligned together in the software and angular deviations(°) of implant placement were measured to compare the results of the two groups.'}, {'measure': 'Operation time', 'timeFrame': 'Surgery day', 'description': 'From anaesthesia to all implants are placed'}, {'measure': 'Implant stability quotient', 'timeFrame': 'Surgery day', 'description': 'Implant stability quotient was measured with the Osstell®device'}, {'measure': 'visual analogue scale', 'timeFrame': 'About 3 days after surgery', 'description': 'Patients were asked how they felt about the procedure using a visual analogue scale (VAS), which was measured using a visual analogue scale from 0 to 10. On a scale of 0 to 10 ("no pain" 0 to "maximum pain" 10) ("very comfortable" 0 to "not at all comfortable" 10) ("no swelling" 0 to "severe swelling" 10)'}, {'measure': 'Failure rate', 'timeFrame': 'About 4 months after surgery', 'description': 'Failure rate of implants during the healing period'}, {'measure': 'Change of marginal bone level(mm)', 'timeFrame': 'About 1 year after surgery', 'description': 'Marginal bone level = Measurement of the distance (mm) between the reference point (shoulder of the implant) and the point of bone-implant contact on the periapical film ; Change of marginal bone level = marginal bone level in the follow-up period - marginal bone level in the baseline period (mm)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Edentulous Jaw']}, 'descriptionModule': {'briefSummary': 'The study was a prospective, multicentre, randomized parallel controlled clinical trial. Randomisation was conducted by central randomisation, with random allocation codes generated by the main central computer. Enrollment was conducted by competition between different centres. In this study, the coronal, apical and angular deviations (mean, standard deviation, median, quartiles, minimum, maximum, 95% confidence interval) of the static template and dynamic navigation group guided implant placement were calculated. The data is proposed to be analysed using a mixed linear effects model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old and above\n* American society of anesthesiologists (ASA) Levels 1 and 2\n* Satisfy any of the following requirements:\n\n 1. Edentulous maxillary patients\n 2. Edentulous mandibular patients\n 3. Terminally edentulous maxillary patients (number of remaining natural teeth in the upper jaw 1-4)\n 4. Terminally edentulous mandibular patients (number of remaining natural teeth in the lower jaw 1-4)\n 5. Full-mouth edentulous patients\n 6. Full-mouth terminally edentulous patients (number of remaining natural teeth in one jaw 1-4)\n* Implant-supported fixed restorations or implant-supported overdenture restorations\n* Sufficient usable bone volume at implant sites, non-implant sites (≥1.5mm of remaining bone width on the labial/buccal and palatal/lingual sides after virtual implant placement in software)\n* Maxillary and mandibular options for full-mouth patients are based on the inclusion of more single jaws in the non-bone grafted sites (see virtual peri-implant bone volume requirements in the pre-operative preparation phase)\n* Mouth opening of 3 fingers or more\n* Single-jawed missing patients treated with systemic periodontal therapy\n\nExclusion Criteria:\n\n* Have a systemic disease that may affect prognosis (e.g. diabetic patients with glycated haemoglobin \\>6.5%, patients on bisphosphonate medication, patients with auto-systemic immune diseases, etc.)\n* ASA grades 3 and 4\n* Acute inflammation in the oral cavity: including uncontrolled periodontitis (periodontal probing depth \\> 4 mm) and untreated acute and chronic apical periodontitis\n* Pregnancy or breastfeeding\n* History of radiotherapy to the head and neck\n* Heavy smokers (more than 10 cigarettes per day)\n* Restricted mouth opening (less than three fingers).\n* Participation in a clinical trial with another drug or device within 30 days prior to the start of the procedure (study day 0).'}, 'identificationModule': {'nctId': 'NCT06051266', 'briefTitle': 'Accuracy of Dynamic Navigation and Static Template in Completely Edentulous Patients', 'organization': {'class': 'OTHER', 'fullName': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}, 'officialTitle': 'Clinical Accuracy Evaluation of Dynamic Navigation and Static Template for Dental Implant Placement in Completely Edentulous Patients: A Randomized Parallel Controlled Multicenter Clinical Trial', 'orgStudyIdInfo': {'id': 'SDC-23-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dynamic navigation', 'interventionNames': ['Device: Dynamic navigation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Static template', 'interventionNames': ['Device: Static template']}], 'interventions': [{'name': 'Dynamic navigation', 'type': 'DEVICE', 'description': 'Dynamic navigation eliminates the need for a laboratory fabrication process and allows for direct visualisation of the operative area during implant placement. Moreover, it can avoid interfering with water cooling. Navigation-assisted surgery makes it possible to modify the implant system, length, diameter or position in real time, both in the perioperative period and during surgery.', 'armGroupLabels': ['Dynamic navigation']}, {'name': 'Static template', 'type': 'DEVICE', 'description': 'In most clinical situations, a static template can be used to assist in guiding the placement of implants precisely. The static guide has some limitations in that it requires additional fabrication time, has insufficient cooling in the surgical field and is not suitable for simultaneous grafting procedures.', 'armGroupLabels': ['Static template']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinyan Chen', 'role': 'CONTACT', 'phone': '+86 15652440777'}], 'facility': "Shanghai Ninth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jinyan Chen', 'role': 'CONTACT', 'email': '15652440777@163.com', 'phone': '+86 15652440777'}], 'overallOfficials': [{'name': 'Yiqun Wu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}