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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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 pr
• Устройство 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
• Устройство 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 inter
• Устройство 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 te

Первичные конечные точки

• Success Rate of Temporary Fixed Restorations [Срок оценки: At the final evaluation visit (Visit 5/up to 6 months).]
• Survival Rate of Temporary Fixed Restorations [Срок оценки: Throughout follow-up period (up to 6 months).]
• Incidence of Clinical Complications [Срок оценки: Throughout follow-up period (up to 6 months).]
• Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) [Срок оценки: Throughout follow-up period (up to 6 months).]

Вторичные конечные точки (3)

• Clinical Evaluation of Masticatory Function (Occlusion Quality) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: Baseline (pre-treatment at Visit 1) and at the final follow-up/definitive delivery checkpoint (Visit 5/up to 6 months).]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Turkey (Türkiye) · 1 центр

• Ege University, Faculty of Dentistry, Department of Prosthodontics — Izmir

Идентификаторы

NCT: NCT07632443 · INFO ON DENT GR · 2025-080

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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