PMCF Study on The Performance and Safety of ON DENT® PMMA Discs/Blocks and Resin Products for Temporary Restorations

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.

NCT Number	NCT07632443
Lead Sponsor	On Dent Tibbi Malzeme Dis Protez Ith. ve Ihr. San. Ltd. Sti.
Conditions	Tooth Loss, Dentin Caries, Tooth Fractures
Enrollment	120 participants
Start Date	2025-12-05
Primary Completion	2027-03-04 (estimated)
Study Completion	2027-07-04 (estimated)
Updated on ClinicalTrials.gov	2026-06-10