[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594177":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":31,"studyPopulation":24,"armGroups":32,"interventions":52,"overallOfficials":24,"centralContacts":58,"locations":24,"responsibleParty":64,"collaborators":24,"id":66,"slug":24,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":24,"maxAge":24,"enrollmentInfo":74,"targetDuration":24,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":24,"overallStatus":83,"whyStopped":24,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":24},{"fullName":5,"class":6},"Egas Moniz - Cooperativa de Ensino Superior, CRL","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Differences before and after occlusal adjustments","The primary outcome is the volumetric difference (in micrometers) before and after occlusal adjustments, in each group.","From enrollment to the end of treatment (8 weeks)",[14],{"measure":15,"description":16,"timeFrame":12},"Patients's aesthetics and comfort self-perception","The secondary outcome measure is the patient's comfort and aesthetics self-perception - with questionnaires, using a numerical scale.",[18],{"measure":19,"description":20,"timeFrame":12},"Occlusion differences between diagnostic wax-ups","Other outcome is the volumetric difference (in micrometers) between the diagnostic wax-ups obtained in each group.",{"allocation":22,"interventionModel":23,"interventionModelDescription":24,"primaryPurpose":25,"observationalModel":24,"timePerspective":24,"maskingInfo":26},"RANDOMIZED","CROSSOVER",null,"TREATMENT",{"masking":27,"maskingDescription":24,"whoMasked":28},"DOUBLE",[29,30],"PARTICIPANT","INVESTIGATOR","The goal of this clinical trial is to evaluate the influence of Facial Scan (FS) and cone beam computed tomography (CBCT) in the prosthodontic treatment planning in patients who require rehabilitation with a single crown, with aims:\n\ni) assessing patient's comfort and aesthetics self-perception; ii) evaluate the influence of a virtual articulator in a diagnostic waxing; iii) evaluate the influence of implementation of FS and CBCT to the current digital procedure with a virtual articulator; iv) evaluate the influence of programming the virtual articulator.\n\nData collection will be carried out in participants, including: an intraoral scan (digital impressions), intraoral and extraoral photographs (DPhotos), CBCT, and facial scan.\n\nIn a CAD\u002FCAM software, we will integrate IOS, CBCT, and FS data into the virtual environment, and it will be possible the articulation of virtual models.\n\nThe digital wax-up for the preparation of the crown will be designed by the prosthodontist and then adjusted based on the occlusion obtained in each of the groups.\n\nThe design and occlusal adjustment of the crown will carry out in four different ways, separating them into the following groups:\n\n* Group 1: IOS + DPhotos - Diagnostic waxing done only with static occlusion, without a virtual articulator (as the laboratories commonly do).\n* Group 2: IOS + DPhotos - Set up the models in the virtual articulator arbitrarily (without CBCT and FS) - with the program's default and standard values.\n* Group 3: IOS + DPhotos + CBCT + FS - Set up the models in the virtual articulator (with CBCT and FS) - with the program's default and standard values.\n* Group 4: IOS + DPhotos + CBCT + FS - Set up the models in the virtual articulator (with CBCT and FS) - with the articulator programmed for the patient - through dynamic scans.\n\nFor the representation of the Group 4, we will program a virtual articulator by modifying the values of the condylar guidance angles, in order to realize the changes that could occur just by modifying them. During the study, we plan to program the articulator with dynamic scans of each patient. These dynamic scans will result in individually customised condylar guidance angles.\n\nFour crown tests will be produced, one for each group, to enable them to be tried out on participants (like a mock-up).\n\nParticipants enrolled in this study will be randomly allocated in the 4 groups, with a computer-generated randomization list (https:\u002F\u002Fwww.randomizer.org\u002F).\n\nAllocation concealment will be performed using sealed and opaque numbered envelopes which were opened by the dentist immediately before the mock-up.\n\nAll the procedures will be performed by one experienced clinician.\n\nThe steps of clinical procedure are:\n\nStep 1 - In the first appointment, the patients mention their smile concerns, and the dentist evaluate and diagnoses.\n\nStep 2 - Digital impressions, and a model of the teeth will be done. Step 3 - Diagnostic wax-up, where dentist and dental laboratory plan the wax-up on the study models.\n\nStep 4 - Diagnostic mock-up, where dentist transfers the diagnostic wax-up to the patient's mouth.\n\nWe will evaluate the volumetric difference (in micrometers) before and after occlusal adjustments, in each group; and the volumetric difference between the diagnostic wax-ups obtained in each group.\n\nAfter each mock-up, a questionnaire will be delivered to the patients in order to assess patients's aesthetics and comfort self-perception, using a numeric scale.",[33,39,44,48],{"label":34,"type":35,"description":36,"interventionNames":37},"Static occlusion","PLACEBO_COMPARATOR","Use IOS + DPhotos - Set up the models and do a diagnostic waxing done only with static occlusion, without a virtual articulator (as the laboratories commonly do).",[38],"Procedure: Try-in of one crown test with a digital wax-up (per group)",{"label":40,"type":41,"description":42,"interventionNames":43},"Virtual articulator (standard values)","ACTIVE_COMPARATOR","Use IOS + DPhotos - Set up the models do a diagnostic waxing in the virtual articulator arbitrarily (without CBCT and FS) - with the program's default and standard values.",[38],{"label":45,"type":41,"description":46,"interventionNames":47},"Virtual articulator with CBCT and FS (standard values)","Use IOS + DPhotos + CBCT + FS - Set up the models and do a diagnostic waxing in the virtual articulator (with CBCT and FS) - with the program's default and standard values.",[38],{"label":49,"type":41,"description":50,"interventionNames":51},"Programmed virtual articulator","Use IOS + DPhotos + CBCT + FS - Set up the models and do a diagnostic waxing in the virtual articulator (with CBCT and FS) - with the articulator programmed for the patient - through dynamic scans.",[38],[53],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":24},"PROCEDURE","Try-in of one crown test with a digital wax-up (per group)","In a CAD\u002FCAM software, we will integrate IOS, CBCT, and FS data into the virtual environment, and it will be possible the articulation of virtual models.\n\nThe digital wax-up for the preparation of the crown will be designed by the prosthodontist and then adjusted based on the occlusion obtained in each of the groups.\n\nThe steps of clinical procedure are:\n\n1. \\- In the first appointment, the patients mention their smile concerns, and the dentist evaluate and diagnoses.\n2. \\- Digital impressions, and a model of the teeth will be done.\n3. \\- Diagnostic wax-up, where dentist and dental laboratory plan the wax-up on the study models.\n4. \\- Diagnostic mock-up, where dentist transfers the diagnostic wax-up to the patient's mouth.\n\nWe will evaluate the volumetric difference between the diagnostic wax-ups obtained in each group.\n\nAfter each mock-up, a questionnaire will be delivered to the patients in order to assess patients's aesthetics and comfort self-perception, using a numeric scale.",[49,34,40,45],[59],{"name":60,"role":61,"phone":62,"phoneExt":24,"email":63},"Sofia Lobo, Masters","CONTACT","+351917789540","slobo@egasmoniz.edu.pt",{"type":65,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100594177",false,"NCT07016048","Digital Technologies in Dental Rehabilitation Planning.","Facial Scanning and Computerized Tomography as Aids in Single-tooth Rehabilitation Planning","PHDSL","Inclusion Criteria:\n\n* Patients who require rehabilitation with a single crown;\n* The tooth to be rehabilitated must have an opponent to test the occlusion.\n\nExclusion Criteria:\n\n* The tooth to be rehabilitated must does not have an opponent to test the occlusion;\n* Edentulous patient;\n* Incapable of understanding and\u002For giving consent.","ALL",{"count":75,"type":76},25,"ESTIMATED","INTERVENTIONAL",[79],"NA","The goal of this clinical trial is to evaluate the influence of Facial Scan (FS) and cone beam computed tomography (CBCT) in the prosthodontic treatment planning in patients who require rehabilitation with a single crown.\n\nAfter collecting the patients, at the first appointment, data collection will be carried out, including: an intraoral scan (digital impressions), intraoral and extraoral photographs, CBCT, and facial scanning.\n\nAt the following appointment, a mock-up will be performed. The purpose of the mock-up is to preview the expected smile outcome before beginning the oral rehabilitation treatment.\n\nAfter each mock-up, patients will be asked to complete a questionnaire designed to evaluate their self-perception of comfort and aesthetics.\n\nAdditionally, after each mock-up, the clinician will assess occlusal contacts (the bite) and record the time required for adjustments to achieve a comfortable occlusion for the patient.\n\nThe main questions it aims to answer are:\n\n* How does the patient perceive comfort and aesthetics during the rehabilitation process?\n* What is the influence of using a virtual articulator on diagnostic waxing accuracy?\n* How does integrating facial scanning (FS) and cone-beam computed tomography (CBCT) affect current digital workflows involving a virtual articulator?\n* What impact does the programming of the virtual articulator have on treatment planning outcomes?",[82],"Digital Technologies in Dental Rehabilitation Planning","NOT_YET_RECRUITING","2025-06-03",{"date":86,"type":87},"2025-06-11","ACTUAL",{"date":89,"type":76},"2025-06",{"date":91,"type":76},"2026-12",{"name":5,"class":6}]