Tests treatment safety and results for Tooth Loss
Official title PMCF Study on The Performance and Safety of ON DENT® PMMA Discs/Blocks and Resin Products for Temporary Restorations
ClinicalTrials.gov ID: NCT07632443
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- 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 treatment clinical study
The study team makes the final eligibility decision.
Where it's taking place
- Izmir, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Izmir, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.