NCT07632443 PMCF Study on The Performance and Safety of ON DENT® PMMA Discs/Blocks and Resin Products for Temporary Restorations
| NCT ID | NCT07632443 |
| Status | Recruiting |
| Phase | — |
| Sponsor | On Dent Tibbi Malzeme Dis Protez Ith. ve Ihr. San. Ltd. Sti. |
| Condition | Tooth Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-12-05 |
| Primary Completion | 2027-03-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-12-05 with a primary completion date of 2027-03-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Mine Dundar Comlekoglu
PRINCIPAL INVESTIGATOR
Ege University, Faculty of Dentistry, Department of Prosthodontics
Frequently Asked Questions
Who can join the NCT07632443 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tooth Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07632443 currently recruiting?
Yes, NCT07632443 is actively recruiting participants. Contact the research team at nurten@on-dent.com for enrollment information.
Where is the NCT07632443 trial being conducted?
This trial is being conducted at Izmir, Turkey (Türkiye).
Who is sponsoring the NCT07632443 clinical trial?
NCT07632443 is sponsored by On Dent Tibbi Malzeme Dis Protez Ith. ve Ihr. San. Ltd. Sti.. The principal investigator is Mine Dundar Comlekoglu at Ege University, Faculty of Dentistry, Department of Prosthodontics. The trial plans to enroll 120 participants.