Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT07190820
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Accuracy of Full-arch Implant Digital and Conventional Impressions.
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-09-14', 'size': 441319, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-20T03:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-20', 'studyFirstSubmitDate': '2025-08-18', 'studyFirstSubmitQcDate': '2025-09-20', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vision and tactile score for evaluating passive fit of metal framework', 'timeFrame': 'Periprocedural: At the time of the titanium framework try-in: the try-in of the framework to the patient is before final delivery. (The delivery of the final prosthesis is the baseline)', 'description': 'Five aspects are evaluated, each aspect is scored as 0 or1. The score ranges from 0 to 5 points. 1、Framework rocking upon seating？2、 Gap assessment with single screw test. The method utilized an explorer with an approximately Ø60-µm tip to evaluate the margins of the metal framework.3、 Gap assessment with all screws tightened. 4、Are the screws threading smoothly? 5、Radiographic assessment of framework fit (check for gaps).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['digital impression', 'implant restoration'], 'conditions': ['Edentulous Jaw']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine whether the accuracy of digital impressions is comparable to conventional impressions. It will also learn about the clinical effect of different method. The main questions it aims to answer are: Does drug ABC lower the number of times participants need to use a rescue inhaler? What medical problems do participants have when taking drug ABC? Researchers will compare digital impression to conventional impression to see if the accuracy of the digital method.\n\nParticipants will:\n\nTake an impression with one of the methods Visit the clinic a total of 6 times for checkups and tests'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 30-80 years (inclusive) with no gender restriction.\n* Patients who will receive a full-arch one-piece implant-supported fixed\n* permanent restoration in the maxilla or mandible.\n* Patients with osseointegrated implants after surgery.\n* Patients voluntarily participate in the trial and sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients with a severe gag reflex.\n* Patients with insufficient interarch space in the posterior region for impression coping placement.\n* Patients with minimal inter-implant distance may prevent impression coping installation.\n* Patients with temporomandibular joint (TMJ) disorders are unable to maintain prolonged mouth opening for impression procedures.\n* Other conditions deemed ineligible for inclusion by the investigator.'}, 'identificationModule': {'nctId': 'NCT07190820', 'briefTitle': 'Comparison of Accuracy of Full-arch Implant Digital and Conventional Impressions.', 'organization': {'class': 'OTHER', 'fullName': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}, 'officialTitle': 'Comparison of the Accuracy of Digital and Conventional Impression in Edentulous Arch', 'orgStudyIdInfo': {'id': 'SH9H-2025-T290-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'digital impression', 'interventionNames': ['Procedure: digital impression']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional impression', 'interventionNames': ['Procedure: conventional impression']}], 'interventions': [{'name': 'digital impression', 'type': 'PROCEDURE', 'description': 'complete arch implant impression with intraoral photogrammetry', 'armGroupLabels': ['digital impression']}, {'name': 'conventional impression', 'type': 'PROCEDURE', 'description': 'conventional open tray splint impression', 'armGroupLabels': ['conventional impression']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Junyu Shi', 'investigatorAffiliation': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}}}}