Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment120 (estimated)
SponsorOn Dent Tibbi Malzeme Dis Protez Ith. ve Ihr. San. Ltd. Sti.
Industry-sponsored
Locations1 site (Izmir)
StatusRecruiting
StartedDecember 5, 2025
Main results expectedMarch 4, 2027
Study endsJuly 4, 2027
Registry record updatedJune 10, 2026
Trial IDNCT07632443 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.