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

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NCT07632443 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aged 18 years or older * Male or female * Requires 1/2/3-unit prosthetic restoration with temporary crown or bridge * No active periodontal disease * No general health condition contraindicated to treatment * Not legally restricted (no military conscription, incarceration, or other legal restriction) * Provision of signed informed consent form Exclusion Criteria: * Suspected or confirmed pregnancy, * Temporomandibular joint disorder or limited mouth opening * Deep subgingival margins (\>0.5 mm) * Non-restorable teeth * Non-functional teeth (no opposing counterpart /antagonist) * Probing depth \>3 mm * Pathological tooth mobility * Unfavorable occlusal relationship or parafunction (bruxism, etc.) * Active systemic infection or condition/treatment that may impede treatment (radiotherapy, bisphosphonate use, etc.) * Inadequate oral hygiene or cognitive/physical disorders impairing daily self-care maintenance. * Uncontrolled alcohol, tobacco, or nicotine product use * History of allergy or hypersensitivity to PMMA or resin components * Concurrent participation in another interventional clinical study
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What it tests

  • 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)
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Where

1 site
Ege University, Faculty of Dentistry, Department of Prosthodontics
Izmir, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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