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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOn Dent Tibbi Malzeme Dis Protez Ith. ve Ihr. San. Ltd. Sti.

About this trial

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.

Eligibility criteria

Qualifiers

Aged 18 years or older

Male or female

Requires 1/2/3-unit prosthetic restoration with temporary crown or bridge

No active periodontal disease

Disqualifiers

Suspected or confirmed pregnancy,

Temporomandibular joint disorder or limited mouth opening

Deep subgingival margins (>0.5 mm)

Non-restorable teeth

Trial design

Treatments tested in this trial

  • Temporary Fixed Prosthesis (Tempo-CAD Monocolor PMMA)
  • Temporary Fixed Prosthesis (Tempo-CAD Monocolor SHT PMMA)
  • Temporary Fixed Prosthesis (Tempo-CAD Multicolor SHT PMMA)
  • Temporary Fixed Prosthesis (Print On - Cyclone Perma Resin)

Treatment groups

120 Participants
are divided into 4 treatment groups