Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-01-01 @ 5:12 AM
Study NCT ID:
NCT04023006
Status:
TERMINATED
Last Update Posted:
2021-02-10
First Post:
2019-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Clinical Case Series Study to Assess Fit and Quality of Full Dentures Fabricated by AM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009066', 'term': 'Mouth, Edentulous'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No usable data were obtained. Therefore, the study was terminated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-08', 'studyFirstSubmitDate': '2019-07-12', 'studyFirstSubmitQcDate': '2019-07-15', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the fit of the denture', 'timeFrame': 'At Final Placement of Denture, through study completion, an average of one month', 'description': 'A questionnaire of assessment of fit by ranking, in comparison to the previous denture, using a Likert Scale from a minimum of 5 to a maximum of 1.\n\nMuch worse (5) Worse (4) Same (3) Better (2) Much better (1)'}], 'secondaryOutcomes': [{'measure': 'Aesthetics of dentures', 'timeFrame': 'At Final Placement of Denture,through study completion, an average of one month', 'description': 'A questionnaire of assessment of aesthetics by ranking, in comparison to the previous denture, using a Likert Scale from a minimum of 5 to a maximum of 1.\n\nMuch worse (5) Worse (4) Same (3) Better (2) Much better (1)'}, {'measure': 'Function of dentures', 'timeFrame': 'At Final Placement of Denture,through study completion, an average of 1 month', 'description': 'A questionnaire of assessment of function by ranking, in comparison to the previous denture, using a Likert Scale from a minimum of 5 to a maximum of 1.\n\nMuch worse (5) Worse (4) Same (3) Better (2) Much better (1)'}, {'measure': "Dentist's satisfaction with treatment: questionnaire", 'timeFrame': 'At Final Placement of Denture, through study completion, an average of 1 month', 'description': 'A questionnaire of assessment of satisfactions of treatment by ranking, in comparison to the previous placed denture, using a Likert Scale from a minimum of 5 to a maximum of 1.\n\nMuch worse (5) Worse (4) Same (3) Better (2) Much better (1)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Denture'], 'conditions': ['Mouth, Edentulous']}, 'referencesModule': {'references': [{'pmid': '14570864', 'type': 'BACKGROUND', 'citation': 'Celebic A, Knezovic-Zlataric D, Papic M, Carek V, Baucic I, Stipetic J. Factors related to patient satisfaction with complete denture therapy. J Gerontol A Biol Sci Med Sci. 2003 Oct;58(10):M948-53. doi: 10.1093/gerona/58.10.m948.'}, {'pmid': '24057919', 'type': 'BACKGROUND', 'citation': 'Schwindling FS, Bomicke W, Hassel AJ, Rammelsberg P, Stober T. Randomized clinical evaluation of a light-cured base material for complete dentures. Clin Oral Investig. 2014;18(5):1457-65. doi: 10.1007/s00784-013-1110-4. Epub 2013 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'This observational clinical case series investigation will be conducted on approximately five (5) enrolled subjects at one (1) site in the US. Treatment of subjects encompasses all steps to fabricate new dentures for maxilla and/or mandible. The subjects will be followed 7-10 days after final delivery of the denture', 'detailedDescription': 'This investigation is undertaken to evaluate the workflow and concomitant products to create full dentures by using additive manufacturing (AM) technology, i.e. Digital Light Processing™ Technology (Carbon 3D) to restore fully edentulous jaws. The assessment includes quality of materials provided by Dentsply Sirona Lab by using printers for AM (M series, Carbon 3D 1089 Mills Way, Redwood City, CA 94063). This assessment will be done by clinical review of the AM dentures on fit and quality. In addition, the evaluation includes a patient survey to assess current dentures and the new AM dentures with a subjective comparison of both.\n\nThe target subjects are male or female, 18 years and older with the need of a full denture in one or both jaws, being completely edentulous. The newly fabricated denture is to replace an existing full denture. For this descriptive study, no minimum number of patients is defined, but to achieve a reasonable subject number, a minimum of five (5) and a maximum of ten (10) patients will be enrolled, i.e. ten to twenty (10-20) denture arches will be fabricated within this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The investigational device is part of a treatment concept for edentulous patients of all ages, gender and races. The incidence for tooth loss has not declined over years, and the prevalence for edentulism is significantly higher for adults 50 years and older. For this descriptive two-part survey, no minimum number of patients is defined, but to achieve a reasonable subject number, a minimum of five (5) patients will be enrolled, i.e. 10 dentures will be fabricated within this study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is 18 years or older.\n* Subject has given written consent to participate in the trial.\n* Subject is in good general health.\n* Subject requires a new removable full denture for both jaws.\n* Subject is completely edentulous in the maxilla and mandible.\n* Subject is already wearing a full denture in the maxilla and mandible.\n* Subject is willing to undergo dental treatment to receive a new full denture for both jaws.\n* Subject confirms availability for treatment and all indicated follow-up visits.\n\nExclusion Criteria:\n\n* Subject is younger than 18 years.\n* Subject is pregnant.\n* Subject has disabilities that do not allow a regular dental treatment.\n* Subject with some systemic medical complications that cause difficulty in impression taking or judging occlusion of device.\n* Subject is currently participating in another study.\n* Subject has an allergic history regarding materials used in this trial.\n* Subject with xerostomia/ dry-mouth syndrome.\n* Lack of compliance is expected.\n* Those subjects who cannot provide informed consent for any reason\n* Acute stomatitis.\n* Status after tumor treatment in head-neck region (removal, radiotherapy).\n* Acute cancer.\n* Incomplete hard and/or soft tissue in the oral cavity.\n* Muscle and/or nerve damage in the head-neck region.\n* Insufficient vertical height and/or insufficient mouth opening.\n* Resilient hyperplastic mucosa ("flappy ridges").\n* Bruxism.\n* Insufficient oral hygiene. The existing dentures should have no visible calculus.\n* Previously enrolled in the present investigation.\n* Involvement in the planning and conduct of the clinical investigation. (applies to all Dentsply Sirona \\& Carbon 3D staff, investigational site staff staff and third party vendor).'}, 'identificationModule': {'nctId': 'NCT04023006', 'briefTitle': 'An Observational Clinical Case Series Study to Assess Fit and Quality of Full Dentures Fabricated by AM', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dentsply Sirona Inc.'}, 'officialTitle': 'An Observational Clinical Case Series Study to Assess Fit and Quality of Full Dentures', 'orgStudyIdInfo': {'id': 'PRPA 22901 / CR 02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Edentulous Patients', 'description': 'The investigational device is part of a treatment concept for edentulous patients of all ages, gender and races. The incidence for tooth loss has not declined over years, and the prevalence for edentulism is significantly higher for adults 50 years and older. For this descriptive two-part survey, no minimum number of patients is defined, but to achieve a reasonable subject number, a minimum of five (5) patients will be enrolled, i.e. 10 dentures will be fabricated within this study.', 'interventionNames': ['Device: Removable prostheses']}], 'interventions': [{'name': 'Removable prostheses', 'type': 'DEVICE', 'otherNames': ['Lucitone 3D print resin dentures'], 'description': 'Full dentures created by Additive manufacturing (Carbon Printers)', 'armGroupLabels': ['Edentulous Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University Goldman School of Dental MEdicine', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dentsply International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}