Temporary dental crowns and bridges using ON DENT materials
Official title: 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
Run by On Dent Tibbi Malzeme Dis Protez Ith. ve Ihr. San. Ltd. Sti. · NCT07632443 · Data updated 2026-11-12
This PMCF study tests whether ON DENT temporary crowns and bridges perform safely and survive as patients wear them while awaiting final prostheses.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | On Dent Tibbi Malzeme Dis Protez Ith. ve Ihr. San. Ltd. Sti. Industry-sponsored |
| Locations | 1 site (Izmir) |
| Status | Recruiting |
| Started | December 5, 2025 |
| Main results expected | March 4, 2027 |
| Study ends | July 4, 2027 |
| Registry record updated | June 10, 2026 |
| Trial ID | NCT07632443 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 or older needing 1–3 unit temporary crowns or bridges, without active periodontal disease or contraindicating health conditions.
✕Probably not a fit
Patients with complex medical conditions or poor oral hygiene may not experience benefit from these temporary restorations.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, single-center study in Turkey enrolls 120 adults needing temporary fixed prosthodontic restorations. Participants are randomized into four groups to compare different ON DENT PMMA discs/blocks and a 3D-printed resin for temporary crowns and bridges. Restorations are fabricated using standardized digital workflows and followed for up to six months across five clinical visits to measure survival, success, biological effects, and patient quality of life. The study aims to provide real-world data on the clinical performance and safety of these temporary materials. All procedures adhere to predefined inclusion/exclusion criteria and standardized laboratory protocols.
Why it matters
Potential benefit: If successful, the study could validate effective temporary options that maintain function and aesthetics during the prosthetic phase.
How similar studies have gone: Prior PMCF and temporary restoration studies have shown variable performance across materials; this study adds organized, real-world data for ON DENT products.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Ege University, Faculty of Dentistry, Department of Prosthodontics
Izmir, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Mine Dundar Comlekoglu — Ege University, Faculty of Dentistry, Department of Prosthodontics
- Study coordinator: Nurten Ozdenler, Sponsor Rep
- Email: nurten@on-dent.com
- Phone: +90 (232) 253 2577
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.