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

Recruiting now · Not applicable

Conditions studied: Tooth Loss, Dentin Caries, Tooth Fractures

In brief

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.

Key facts

Study ID

NCT07632443

Run by

On Dent Tibbi Malzeme Dis Protez Ith. ve Ihr. San. Ltd. Sti.

People needed

120

Starts

2025-12-05

Expected to finish

2027-07-04

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ege University, Faculty of Dentistry, Department of Prosthodontics — Izmir, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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