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PMCF Study on The Performance and Safety of ON DENT® PMMA Discs/Blocks and Resin Products for Temporary Restorations
Sponsor: On Dent Tibbi Malzeme Dis Protez Ith. ve Ihr. San. Ltd. Sti.
Summary
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.
Official title: Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Performance and Safety of ON DENT™ PMMA Disc/Block and Resin Products Used in Temporary Restoration Fabrication
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-12-05
Completion Date
2027-07-04
Last Updated
2026-06-10
Healthy Volunteers
No
Conditions
Interventions
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/block restorative material via high-precision centralized CAD/CAM 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.
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/block restorative material via high-precision centralized CAD/CAM 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.
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/block restorative material via high-precision centralized CAD/CAM 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.
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.
Locations (1)
Ege University, Faculty of Dentistry, Department of Prosthodontics
Izmir, Turkey (Türkiye)