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Recruiting
NCT07632443
PMCF Study on The Performance and Safety of ON DENT® PMMA Discs/Blocks and Resin Products for Temporary Restorations
Conditions: Tooth Loss, Dentin Caries, Tooth Fractures
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: On Dent Tibbi Malzeme Dis Protez Ith. ve Ihr. San. Ltd. Sti.
Location: Ege University, Faculty of Dentistry, Department of Prosthodontics Izmir
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07632443). StuddyBuddy aggregates publicly available trial information.