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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Success Rate of Temporary Fixed Restorations
Timeframe: At the final evaluation visit (Visit 5/up to 6 months).
2
Survival Rate of Temporary Fixed Restorations
Timeframe: Throughout follow-up period (up to 6 months).
3
Incidence of Clinical Complications
Timeframe: Throughout follow-up period (up to 6 months).
4
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Timeframe: Throughout follow-up period (up to 6 months).
Trial details
NCT IDNCT07632443
SponsorOn Dent Tibbi Malzeme Dis Protez Ith. ve Ihr. San. Ltd. Sti.