RecruitingNot ApplicableNCT07632443

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

Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Performance and Safety of ON DENT™ PMMA Disc/Block and Resin Products Used in Temporary Restoration Fabrication

Sponsor

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

Enrollment

120 participants

Start Date

Dec 5, 2025

Study Type

INTERVENTIONAL

Conditions

Tooth-loss Tooth Fractures Dentin Caries

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria13

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

Interested in this trial?

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Interventions

DEVICETemporary Fixed Prosthesis (Tempo-CAD Monocolor PMMA)

A custom-fabricated, 1-to-3 unit temporary fixed prosthodontic restoration (temporary crowns or bridges) produced through automated digital workflows. The provisional prosthesis is manufactured specifically from the ON DENT™ Tempo-CAD Monocolor PMMA (polymethyl methacrylate) disc/block restorative material via high-precision centralized CAD/CAM milling procedures. The restoration is clinically delivered and cemented using an identical temporary cement brand to serve as an interim fixed dental prosthesis during the evaluative period.

DEVICETemporary Fixed Prosthesis (Tempo-CAD Monocolor SHT PMMA)

A custom-fabricated, 1-to-3 unit temporary fixed prosthodontic restoration (temporary crowns or bridges) produced through automated digital workflows. The provisional prosthesis is manufactured specifically from the ON DENT™ Tempo-CAD Monocolor SHT (super-high translucent) PMMA disc/block restorative material via high-precision centralized CAD/CAM milling procedures. The restoration is clinically delivered and cemented using an identical temporary cement brand to serve as an interim fixed dental prosthesis during the evaluative period.

DEVICETemporary Fixed Prosthesis (Tempo-CAD Multicolor SHT PMMA)

A custom-fabricated, 1-to-3 unit temporary fixed prosthodontic restoration (temporary crowns or bridges) produced through automated digital workflows. The provisional prosthesis is manufactured specifically from the ON DENT™ Tempo-CAD Multicolor SHT (super-high translucent) multi-layered PMMA disc/block restorative material via high-precision centralized CAD/CAM milling procedures. The restoration is clinically delivered and cemented using an identical temporary cement brand to serve as an interim fixed dental prosthesis during the evaluative period.

DEVICETemporary Fixed Prosthesis (Print On - Cyclone Perma Resin)

A custom-fabricated, 1-to-3 unit temporary fixed prosthodontic restoration (temporary crowns or bridges) produced through automated digital workflows. The provisional prosthesis is manufactured specifically from the ON DENT™ Print On Cyclone Perma fluid, light-curable dimethacrylate-based photopolymer acrylic resin material via centralized stereolithographic 3D printing utilizing DLP (digital light processing) technology. The restoration is clinically delivered and cemented using an identical temporary cement brand to serve as an interim fixed dental prosthesis during the evaluative period.