[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642394":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":48,"centralContacts":53,"locations":59,"responsibleParty":79,"collaborators":35,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":35,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":35,"enrollmentInfo":90,"targetDuration":35,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":61,"whyStopped":35,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"On Dent Tibbi Malzeme Dis Protez Ith. ve Ihr. San. Ltd. Sti.","INDUSTRY",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"MONOCOLOR PMMA","EXPERIMENTAL","This study arm comprising 30 adult patients who will receive 1-to-3 unit temporary crown or bridge restorations fabricated from monocolor polymethyl methacrylate (PMMA) discs\u002Fblocks. The provisional prostheses will be designed using specialized computer-aided design (CAD) software and manufactured via computerized milling units (CAM). Following clinical delivery with a standardized temporary cement, the restorations will undergo prospective performance and safety evaluations using the Revised FDI Criteria. Data collected for this cohort will be analyzed and reported independently utilizing descriptive statistics and longitudinal intra-group analyses, with no direct statistical comparison intended between independent arms.",[13],"Device: Temporary Fixed Prosthesis (Tempo-CAD Monocolor PMMA)",{"label":15,"type":10,"description":16,"interventionNames":17},"MONOCOLOR SHT PMMA","This study arm comprising 30 adult patients who will receive 1-to-3 unit temporary crown or bridge restorations fabricated from monocolor super-high translucent (SHT) polymethyl methacrylate (PMMA) discs\u002Fblocks. The provisional prostheses will be designed using specialized computer-aided design (CAD) software and manufactured via computerized milling units (CAM). Following clinical delivery with a standardized temporary cement, the restorations will undergo prospective performance and safety evaluations using the Revised FDI Criteria. Data collected for this cohort will be analyzed and reported independently utilizing descriptive statistics and longitudinal intra-group analyses, with no direct statistical comparison intended between independent arms.",[18],"Device: Temporary Fixed Prosthesis (Tempo-CAD Monocolor SHT PMMA)",{"label":20,"type":10,"description":21,"interventionNames":22},"MULTICOLOR SHT PMMA","This study arm comprising 30 adult patients who will receive 1-to-3 unit temporary crown or bridge restorations fabricated from multi-layered (multicolor) super-high translucent (SHT) polymethyl methacrylate (PMMA) discs\u002Fblocks. The provisional prostheses will be designed using specialized computer-aided design (CAD) software and manufactured via computerized milling units (CAM). Following clinical delivery with a standardized temporary cement, the restorations will undergo prospective performance and safety evaluations using the Revised FDI Criteria. Data collected for this cohort will be analyzed and reported independently utilizing descriptive statistics and longitudinal intra-group analyses, with no direct statistical comparison intended between independent arms.",[23],"Device: Temporary Fixed Prosthesis (Tempo-CAD Multicolor SHT PMMA)",{"label":25,"type":10,"description":26,"interventionNames":27},"3D Printer Resin","This study arm comprising 30 adult patients who will receive 1-to-3 unit temporary crown or bridge restorations fabricated from fluid, light-curable dimethacrylate-based photopolymer resin. The provisional prostheses will be designed using specialized computer-aided design (CAD) software and manufactured through stereolithographic 3D printing utilizing Digital Light Processing (DLP) technology. Following clinical delivery with a standardized temporary cement, the restorations will undergo prospective performance and safety evaluations using the Revised FDI Criteria. Data collected for this cohort will be analyzed and reported independently utilizing descriptive statistics and longitudinal intra-group analyses, with no direct statistical comparison intended between independent arms.",[28],"Device: Temporary Fixed Prosthesis (Print On - Cyclone Perma Resin)",[30,36,40,44],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DEVICE","Temporary Fixed Prosthesis (Tempo-CAD Monocolor PMMA)","A custom-fabricated, 1-to-3 unit temporary fixed prosthodontic restoration (temporary crowns or bridges) produced through automated digital workflows. The provisional prosthesis is manufactured specifically from the ON DENT™ Tempo-CAD Monocolor PMMA (polymethyl methacrylate) disc\u002Fblock restorative material via high-precision centralized CAD\u002FCAM milling procedures. The restoration is clinically delivered and cemented using an identical temporary cement brand to serve as an interim fixed dental prosthesis during the evaluative period.",[9],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Temporary Fixed Prosthesis (Tempo-CAD Monocolor SHT PMMA)","A custom-fabricated, 1-to-3 unit temporary fixed prosthodontic restoration (temporary crowns or bridges) produced through automated digital workflows. The provisional prosthesis is manufactured specifically from the ON DENT™ Tempo-CAD Monocolor SHT (super-high translucent) PMMA disc\u002Fblock restorative material via high-precision centralized CAD\u002FCAM milling procedures. The restoration is clinically delivered and cemented using an identical temporary cement brand to serve as an interim fixed dental prosthesis during the evaluative period.",[15],{"type":31,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"Temporary Fixed Prosthesis (Tempo-CAD Multicolor SHT PMMA)","A custom-fabricated, 1-to-3 unit temporary fixed prosthodontic restoration (temporary crowns or bridges) produced through automated digital workflows. The provisional prosthesis is manufactured specifically from the ON DENT™ Tempo-CAD Multicolor SHT (super-high translucent) multi-layered PMMA disc\u002Fblock restorative material via high-precision centralized CAD\u002FCAM milling procedures. The restoration is clinically delivered and cemented using an identical temporary cement brand to serve as an interim fixed dental prosthesis during the evaluative period.",[20],{"type":31,"name":45,"description":46,"armGroupLabels":47,"otherNames":35},"Temporary Fixed Prosthesis (Print On - Cyclone Perma Resin)","A custom-fabricated, 1-to-3 unit temporary fixed prosthodontic restoration (temporary crowns or bridges) produced through automated digital workflows. The provisional prosthesis is manufactured specifically from the ON DENT™ Print On Cyclone Perma fluid, light-curable dimethacrylate-based photopolymer acrylic resin material via centralized stereolithographic 3D printing utilizing DLP (digital light processing) technology. The restoration is clinically delivered and cemented using an identical temporary cement brand to serve as an interim fixed dental prosthesis during the evaluative period.",[25],[49],{"name":50,"affiliation":51,"role":52},"Mine Dundar Comlekoglu","Ege University, Faculty of Dentistry, Department of Prosthodontics","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":35,"email":58},"Nurten Ozdenler, Sponsor Rep","CONTACT","+90 (232) 253 2577","nurten@on-dent.com",[60],{"facility":51,"status":61,"city":62,"state":35,"zip":63,"country":64,"countryCode":35,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"RECRUITING","Izmir","35040","Turkey (Türkiye)",{"type":66,"coordinates":67},"Point",[68,69],27.13838,38.41273,{"lat":69,"lon":68},[72,76],{"name":73,"role":56,"phone":74,"phoneExt":35,"email":75},"Mine Dundar Comlekoglu, Professor","+90 (532) 552 74 16","minedundar@yahoo.com",{"name":77,"role":78,"phone":35,"phoneExt":35,"email":35},"Ozgur Yasar, MD, Spec.","SUB_INVESTIGATOR",{"type":80,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100642394","pmcf-study-on-the-performance-and-safety-of-on-dent-pmma-discsblocks-and-resin-products-for-temporary-restorations-100642394",false,"NCT07632443","PMCF Study on The Performance and Safety of ON DENT® PMMA Discs\u002FBlocks and Resin Products for Temporary Restorations","Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Performance and Safety of ON DENT™ PMMA Disc\u002FBlock and Resin Products Used in Temporary Restoration Fabrication","Inclusion Criteria:\n\n* Aged 18 years or older\n* Male or female\n* Requires 1\u002F2\u002F3-unit prosthetic restoration with temporary crown or bridge\n* No active periodontal disease\n* No general health condition contraindicated to treatment\n* Not legally restricted (no military conscription, incarceration, or other legal restriction)\n* Provision of signed informed consent form\n\nExclusion Criteria:\n\n* Suspected or confirmed pregnancy,\n* Temporomandibular joint disorder or limited mouth opening\n* Deep subgingival margins (\\>0.5 mm)\n* Non-restorable teeth\n* Non-functional teeth (no opposing counterpart \u002Fantagonist)\n* Probing depth \\>3 mm\n* Pathological tooth mobility\n* Unfavorable occlusal relationship or parafunction (bruxism, etc.)\n* Active systemic infection or condition\u002Ftreatment that may impede treatment (radiotherapy, bisphosphonate use, etc.)\n* Inadequate oral hygiene or cognitive\u002Fphysical disorders impairing daily self-care maintenance.\n* Uncontrolled alcohol, tobacco, or nicotine product use\n* History of allergy or hypersensitivity to PMMA or resin components\n* Concurrent participation in another interventional clinical study","ALL","18 Years",{"count":91,"type":92},120,"ESTIMATED","INTERVENTIONAL",[95],"NA","This prospective, single-center, interventional post-market clinical follow-up (PMCF) study aims to evaluate the clinical performance and safety of temporary crown and bridge restorations fabricated using CE-marked ON DENT™ restorative materials throughout their functional intraoral clinical duration. A total of 120 adult patients requiring fixed prosthodontic treatments will be randomly assigned to four independent parallel groups (30 patients per group) based on the specific type of temporary material utilized: Tempo-CAD Monocolor PMMA, Tempo-CAD Monocolor SHT PMMA, Tempo-CAD Multicolor SHT PMMA, or Print On Cyclone Perma liquid resin. Patients will be monitored closely across 5 clinical visits up to a maximum duration of 6 months to assess prosthodontic survival, success rates, biological adaptations, and patient-reported quality of life outcomes.",[98,99,100],"Tooth Loss","Dentin Caries","Tooth Fractures",[102,103,104,105,106,107,108,109,110],"Post-Market Clinical Follow-Up (PMCF)","Temporary Dental Restoration","Dental Prosthetics","Temporary Crown","Temporary Bridge","PMMA","Dental Resin","CAD\u002FCAM Dentistry","Revised FDI Criteria","2026-06-07",{"date":113,"type":114},"2026-06-10","ACTUAL",{"date":116,"type":114},"2025-12-05",{"date":118,"type":92},"2027-07-04",{"name":5,"class":6},1]