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PMCF Study on The Performance and Safety of ON DENT® PMMA Discs/Blocks and Resin Products for Temporary Restorations

2. června 2026 aktualizováno: On Dent Tibbi Malzeme Dis Protez Ith. ve Ihr. San. Ltd. Sti.

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

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

This study is designed as a prospective, single-center, randomized, parallel-group clinical evaluation in Turkey to gather real-world data on PMMA polymer blocks and liquid resins manufactured by ON-DENT Ltd. Sti. Temporary fixed restorations play an essential role in protecting prepared natural teeth or dental implants, maintaining positional stability, and ensuring aesthetic and masticatory functions until the delivery of final definitive prostheses.

Participants meeting all eligibility criteria will be randomized via a balanced computer-generated Python permutation algorithm into four arms:

  • Group A: ON DENT™ Tempo-CAD Monocolor PMMA Disc/Block
  • Group B: ON DENT™ Tempo-CAD Monocolor SHT PMMA Disc/Block
  • Group C: ON DENT™ Tempo-CAD Multicolor SHT PMMA Disc/Block
  • Group D: ON DENT™ Print On Cyclone Perma 3D Printer Resin

Clinical and laboratory procedures are rigorously standardized to eliminate confounding variables across all study arms. All provisional restorations will be fabricated using uniform digital dental workflows at a single certified dental laboratory. For Groups A, B, and C, crowns and bridges will be produced via high-precision digital scanning, computer-aided design (CAD) software, and computerized milling units (CAD/CAM). For Group D, restorations will be processed through digital scanning, CAD software, and stereolithographic 3D printing methodologies utilizing digital light processing (DLP) technology. To ensure clinical standardization and minimize inter-operator variability, all clinical interventions, prosthodontic evaluations, and cementation workflows will be performed by prosthodontic investigators adhering to identical operational and clinical protocols, utilizing an identical temporary cement brand.

The evaluative timeline consists of five major operational checkpoints: Baseline (Visit 1: Tooth Preparation & Impression), Visit 2 (Provisional Delivery at days 1-3), Visit 3 (Substructure Framework Try-in at day 8±2), Visit 4 (Aesthetic Try-in at day 12±2), and Visit 5 (Final Definitive Delivery at day 15±2). Longitudinal follow-up evaluations will cover the entire clinical service life of the temporary restorations up to a maximum duration of 6 months, explicitly tracking the period from initial tooth preparation until the formal delivery of the definitive prosthesis. All clinical, biological, and functional prosthodontic outcomes will be verified multi-dimensionally using the internationally recognized Revised World Dental Federation (FDI) Criteria.

Typ studie

Intervenční

Zápis (Odhadovaný)

120

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Nurten Ozdenler, Sponsor Rep
  • Telefonní číslo: +90 (232) 253 2577
  • E-mail: nurten@on-dent.com

Studijní místa

  • Turecko (Türkiye)
      • Izmir, Turecko (Türkiye), 35040
        • Nábor
        • Ege University, Faculty of Dentistry, Department of Prosthodontics
        • Kontakt:
          • Mine Dundar Comlekoglu, Professor
          • Telefonní číslo: +90 (532) 552 74 16
          • E-mail: minedundar@yahoo.com
        • Dílčí vyšetřovatel:
          • Ozgur Yasar, MD, Spec.

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: MONOCOLOR PMMA
This study arm comprising 30 adult patients who will receive 1-to-3 unit temporary crown or bridge restorations fabricated from monocolor polymethyl methacrylate (PMMA) discs/blocks. The provisional prostheses will be designed using specialized computer-aided design (CAD) software and manufactured via computerized milling units (CAM). Following clinical delivery with a standardized temporary cement, the restorations will undergo prospective performance and safety evaluations using the Revised FDI Criteria. Data collected for this cohort will be analyzed and reported independently utilizing descriptive statistics and longitudinal intra-group analyses, with no direct statistical comparison intended between independent arms.
Přístroj: Temporary Fixed Prosthesis (Tempo-CAD Monocolor PMMA)
A custom-fabricated, 1-to-3 unit temporary fixed prosthodontic restoration (temporary crowns or bridges) produced through automated digital workflows. The provisional prosthesis is manufactured specifically from the ON DENT™ Tempo-CAD Monocolor PMMA (polymethyl methacrylate) disc/block restorative material via high-precision centralized CAD/CAM milling procedures. The restoration is clinically delivered and cemented using an identical temporary cement brand to serve as an interim fixed dental prosthesis during the evaluative period.
Experimentální: MONOCOLOR SHT PMMA
This study arm comprising 30 adult patients who will receive 1-to-3 unit temporary crown or bridge restorations fabricated from monocolor super-high translucent (SHT) polymethyl methacrylate (PMMA) discs/blocks. The provisional prostheses will be designed using specialized computer-aided design (CAD) software and manufactured via computerized milling units (CAM). Following clinical delivery with a standardized temporary cement, the restorations will undergo prospective performance and safety evaluations using the Revised FDI Criteria. Data collected for this cohort will be analyzed and reported independently utilizing descriptive statistics and longitudinal intra-group analyses, with no direct statistical comparison intended between independent arms.
Přístroj: Temporary Fixed Prosthesis (Tempo-CAD Monocolor SHT PMMA)
A custom-fabricated, 1-to-3 unit temporary fixed prosthodontic restoration (temporary crowns or bridges) produced through automated digital workflows. The provisional prosthesis is manufactured specifically from the ON DENT™ Tempo-CAD Monocolor SHT (super-high translucent) PMMA disc/block restorative material via high-precision centralized CAD/CAM milling procedures. The restoration is clinically delivered and cemented using an identical temporary cement brand to serve as an interim fixed dental prosthesis during the evaluative period.
Experimentální: MULTICOLOR SHT PMMA
This study arm comprising 30 adult patients who will receive 1-to-3 unit temporary crown or bridge restorations fabricated from multi-layered (multicolor) super-high translucent (SHT) polymethyl methacrylate (PMMA) discs/blocks. The provisional prostheses will be designed using specialized computer-aided design (CAD) software and manufactured via computerized milling units (CAM). Following clinical delivery with a standardized temporary cement, the restorations will undergo prospective performance and safety evaluations using the Revised FDI Criteria. Data collected for this cohort will be analyzed and reported independently utilizing descriptive statistics and longitudinal intra-group analyses, with no direct statistical comparison intended between independent arms.
Přístroj: Temporary Fixed Prosthesis (Tempo-CAD Multicolor SHT PMMA)
A custom-fabricated, 1-to-3 unit temporary fixed prosthodontic restoration (temporary crowns or bridges) produced through automated digital workflows. The provisional prosthesis is manufactured specifically from the ON DENT™ Tempo-CAD Multicolor SHT (super-high translucent) multi-layered PMMA disc/block restorative material via high-precision centralized CAD/CAM milling procedures. The restoration is clinically delivered and cemented using an identical temporary cement brand to serve as an interim fixed dental prosthesis during the evaluative period.
Experimentální: 3D Printer Resin
This study arm comprising 30 adult patients who will receive 1-to-3 unit temporary crown or bridge restorations fabricated from fluid, light-curable dimethacrylate-based photopolymer resin. The provisional prostheses will be designed using specialized computer-aided design (CAD) software and manufactured through stereolithographic 3D printing utilizing Digital Light Processing (DLP) technology. Following clinical delivery with a standardized temporary cement, the restorations will undergo prospective performance and safety evaluations using the Revised FDI Criteria. Data collected for this cohort will be analyzed and reported independently utilizing descriptive statistics and longitudinal intra-group analyses, with no direct statistical comparison intended between independent arms.
Přístroj: Temporary Fixed Prosthesis (Print On - Cyclone Perma Resin)
A custom-fabricated, 1-to-3 unit temporary fixed prosthodontic restoration (temporary crowns or bridges) produced through automated digital workflows. The provisional prosthesis is manufactured specifically from the ON DENT™ Print On Cyclone Perma fluid, light-curable dimethacrylate-based photopolymer acrylic resin material via centralized stereolithographic 3D printing utilizing DLP (digital light processing) technology. The restoration is clinically delivered and cemented using an identical temporary cement brand to serve as an interim fixed dental prosthesis during the evaluative period.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Success Rate of Temporary Fixed Restorations
Časové okno: At the final evaluation visit (Visit 5/up to 6 months).
The success rate of the provisional restorations will be evaluated using the Revised World Dental Federation (FDI) criteria. For statistical analysis, the 5-point scale data will be dichotomized into "sufficient" and "insufficient" categories. Restorations scoring 1 to 3 points-representing clinically excellent/very good (1), clinically good (2), or clinically satisfactory (3) status-will be categorized as "sufficient" (success). Restorations scoring 4 (clinically insufficient/partially insufficient) or 5 (clinically poor/completely insufficient) points will be categorized as "insufficient" (failure). The success rate will be calculated as the final percentage of sufficient restorations within each independent arm.
At the final evaluation visit (Visit 5/up to 6 months).
Survival Rate of Temporary Fixed Restorations
Časové okno: Throughout follow-up period (up to 6 months).
The survival rate of the provisional restorations will be evaluated using the Revised FDI criteria. The calculation of the survival rate uses the dichotomization of the data into "restoration present including repaired" (scores 1-4) and "not present/failed" (score 5). Restorations scoring 1 to 4 points-encompassing all clinically sufficient statuses (1-3) and those evaluated as clinically insufficient but retained in function via repair or re-cementation (4)-will be categorized as "restoration present including repaired" (survived). Restorations scoring 5 points, indicating completely insufficient status or a restoration that is no longer present, will be categorized as "not present/failed". Cumulative survival probabilities over time will be estimated using the Kaplan-Meier method.
Throughout follow-up period (up to 6 months).
Incidence of Clinical Complications
Časové okno: Throughout follow-up period (up to 6 months).
The safety and clinical durability profiles of the provisional fixed dental restorations will be evaluated based on the frequency and specific types of technical, mechanical, or biological complications documented during the follow-up period. Data will be analyzed and reported independently for each study arm as the absolute count (n) and the percentage (%) of restorations experiencing at least one complication, utilizing descriptive and intra-group longitudinal statistics
Throughout follow-up period (up to 6 months).
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Časové okno: Throughout follow-up period (up to 6 months).
Safety and tolerability tracking evaluated through the occurrence, severity, and causality-related frequencies of any reported Adverse Events (AE), Serious Adverse Events (SAE), and device deficiencies. Evaluations are conducted in accordance with the Medical Device Coordination Group (MDCG 2020-10/1) guidelines. Data will be analyzed independently within each device arm, reporting the absolute number of events and the percentage of participants affected.
Throughout follow-up period (up to 6 months).

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Clinical Evaluation of Masticatory Function (Occlusion Quality)
Časové okno: Baseline (pre-treatment at Visit 1) and at all subsequent follow-up checkpoints (Visit 2, Visit 3, Visit 4, and Visit 5/up to 6 months).
Objective clinical evaluation of the chewing function through occlusal contact distribution. The assessment will be performed using extra-thin articulation paper ($<10$ $\mu\text{m}$) under light masticatory force in centric relation. The examining dentist will evaluate whether ideal occlusal contact is established and if forces are evenly distributed across the dental arch (recorded as a binary outcome: "Yes/Acceptable Occlusion" or "No/Unacceptable Occlusion"). Data will be reported as the frequency and percentage of successful occlusal alignment within each independent study arm, tracking longitudinal intra-group changes.
Baseline (pre-treatment at Visit 1) and at all subsequent follow-up checkpoints (Visit 2, Visit 3, Visit 4, and Visit 5/up to 6 months).
Patient-Reported Masticatory Satisfaction
Časové okno: Baseline (pre-treatment at Visit 1) and at all subsequent follow-up checkpoints (Visit 2, Visit 3, Visit 4, and Visit 5/up to 6 months).
Subjective patient-reported evaluation of satisfaction regarding chewing efficiency and functional comfort. This parameter will be quantified using a standard 5-point Likert scale, ranging from a score of 1 ("Not satisfied at all") to 5 ("Very satisfied"). Higher summary scores represent superior patient-reported functional comfort. Statistical analysis will be performed independently within each arm using longitudinal descriptive statistics to monitor changes from baseline.
Baseline (pre-treatment at Visit 1) and at all subsequent follow-up checkpoints (Visit 2, Visit 3, Visit 4, and Visit 5/up to 6 months).
Oral Health-Related Quality of Life (OHRQoL)
Časové okno: Baseline (pre-treatment at Visit 1) and at the final follow-up/definitive delivery checkpoint (Visit 5/up to 6 months).
Oral health-related quality of life will be measured using the validated Turkish version of the Oral Health Impact Profile-14 (OHIP-14) questionnaire. The instrument evaluates 14 items distributed across 7 conceptual subdomains (functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and social disadvantage). Each item is scored on a 5-point Likert scale from 0 ("Never") to 4 ("Very often"). Total summary scores range from 0 to 56, where lower overall scores represent better OHRQoL and higher scores indicate a greater negative impact of oral health conditions. Analysis will track the longitudinal shift within each independent arm.
Baseline (pre-treatment at Visit 1) and at the final follow-up/definitive delivery checkpoint (Visit 5/up to 6 months).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

On Dent Tibbi Malzeme Dis Protez Ith. ve Ihr. San. Ltd. Sti.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Mine Dundar Comlekoglu, Ege University, Faculty of Dentistry, Department of Prosthodontics

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

5. prosince 2025

Primární dokončení (Odhadovaný)

4. března 2027

Dokončení studie (Odhadovaný)

4. července 2027

Termíny zápisu do studia

První předloženo

2. června 2026

První předloženo, které splnilo kritéria kontroly kvality

2. června 2026

První zveřejněno (Aktuální)

8. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. června 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • INFO ON DENT GR
  • 2025-080 (Jiný identifikátor: Turkish Medicines and Medical Devices Agency (TITCK))

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual Participant Data (IPD) will not be shared publicly due to the strict confidentiality requirements, personal data protection legislation (KVKK Law No. 6698), and commercial intellectual property rights policies of the sponsor.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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