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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Temporary Fixed Prosthesis (Print On - Cyclone Perma Resin) (Device)
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.
干预措施: Temporary Fixed Prosthesis (Tempo-CAD Monocolor PMMA) (Device)
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.
干预措施: Temporary Fixed Prosthesis (Tempo-CAD Monocolor SHT PMMA) (Device)
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.
干预措施: Temporary Fixed Prosthesis (Tempo-CAD Multicolor SHT PMMA) (Device)
结局指标
主要结局
未指定
次要结局
- Clinical Evaluation of Masticatory Function (Occlusion Quality)(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).)