Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT06745232
Status:
RECRUITING
Last Update Posted:
2025-03-07
First Post:
2024-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
New Stereophotogrammetry System to Capture Complete-arch Impression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011475', 'term': 'Prosthesis Failure'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2024-12-17', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prosthetic Success', 'timeFrame': '3 months', 'description': 'Prosthetic success of interim prosthesis in term of passivity and tissues adaptability'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['fixed prosthesis', 'stereophotogrammetry', 'immediate loading'], 'conditions': ['Prosthetic Complication', 'Prosthesis Failure, Dental']}, 'descriptionModule': {'briefSummary': 'Patients in need of complete arch restorations will be treated with dynamic navigation system. Once the implants are positioned, a new system of stereophotogrammetry will record the implant positions to capture a precise impression to deliver a fixed screw retained interim prosthesis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in need of complete arch rehabilitations with dental implants and fixed dental prosthesis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy patients aged ≥18 years\n2. Full mouth bleeding and full mouth plaque index lower than or equal to 25%\n3. Bone height for at least 10 mm long implants\n4. Bone width of at least 5 mm and 6 mm for narrow (NP 3.75/3.5 mm) and regular (RP 4.3 mm) implants, respectively\n5. Fresh extraction sockets with an intact buccal wall\n6. At least 4 and 5 mm of bone beyond the root apex in the mandible and maxilla\n7. Minimal insertion torque of 45 Ncm\n\nExclusion Criteria:\n\n1. General medical (American Society of Anesthesiologists, ASA, class III or IV) and/or psychiatric contraindications\n2. Pregnancy and/or breastfeeding\n3. Any interfering medication such as steroid therapy or bisphosphonate therapy\n4. Alcohol and/or drug abuse\n5. Heavy smoking (\\>10 cigarettes/day)\n6. Radiation therapy to head or neck region within 5 years\n7. Untreated periodontitis\n8. Acute and chronic infections of the adjacent tissues or natural dentition\n9. Severe maxillomandibular skeletal discrepancy\n10. High and moderate parafunctional activity\n11. Absence of opposite teeth'}, 'identificationModule': {'nctId': 'NCT06745232', 'briefTitle': 'New Stereophotogrammetry System to Capture Complete-arch Impression', 'organization': {'class': 'OTHER', 'fullName': 'University of Rome Tor Vergata'}, 'officialTitle': 'The Use of a New Stereophotogrammetry System to Capture Intra-operative Complete-arch Impression', 'orgStudyIdInfo': {'id': 'FASTMAPPROSPECTIVE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FAST MAP', 'description': 'Patients with complete arch restorations loaded immediately with a full digital workflow using stereophotogrammetry Intraoral impression', 'interventionNames': ['Device: FAST MAP']}], 'interventions': [{'name': 'FAST MAP', 'type': 'DEVICE', 'description': 'Patients with complete arch restorations loaded immediately with a full digital workflow using stereophotogrammetry Intraoral impression', 'armGroupLabels': ['FAST MAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00133', 'city': 'Roma', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Carosi, PhD', 'role': 'CONTACT', 'email': 'paolo.carosi@alumni.uniroma2.eu'}], 'facility': 'PTV', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Paolo Carosi, PhD', 'role': 'CONTACT', 'email': 'paolo.carosi@alumni.uniroma2.eu', 'phone': '327798699', 'phoneExt': '+39'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rome Tor Vergata', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post-doc Researcher', 'investigatorFullName': 'Paolo Carosi', 'investigatorAffiliation': 'University of Rome Tor Vergata'}}}}