PMCF Study on The Performance and Safety of ON DENT® PMMA Discs/Blocks and Resin Products for Temporary Restorations
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.
研究概览
地位
招聘中
详细说明
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.
研究类型
介入性
注册 (估计的)
120
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Nurten Ozdenler, Sponsor Rep
- 电话号码：+90 (232) 253 2577
- 邮箱：nurten@on-dent.com
学习地点
-
-
-
Izmir、土耳其（türkiye）、35040
- 招聘中
- Ege University, Faculty of Dentistry, Department of Prosthodontics
-
接触：
- Mine Dundar Comlekoglu, Professor
- 电话号码：+90 (532) 552 74 16
- 邮箱：minedundar@yahoo.com
-
副研究员：
- Ozgur Yasar, MD, Spec.
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
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.
|
|
实验性的：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.
|
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.
|
|
实验性的：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.
|
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.
|
|
实验性的：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.
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Success Rate of Temporary Fixed Restorations
大体时间：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
大体时间：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
大体时间：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)
大体时间：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).
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient-Reported Masticatory Satisfaction
大体时间：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)
大体时间：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).
|
|
Clinical Evaluation of Masticatory Function (Occlusion Quality)
大体时间：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 μm) 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).
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mine Dundar Comlekoglu、Ege University, Faculty of Dentistry, Department of Prosthodontics
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年12月5日
初级完成 (估计的)
2027年3月4日
研究完成 (估计的)
2027年7月4日
研究注册日期
首次提交
2026年6月2日
首先提交符合 QC 标准的
2026年6月2日
首次发布 (实际的)
2026年6月8日
研究记录更新
最后更新发布 (实际的)
2026年6月10日
上次提交的符合 QC 标准的更新
2026年6月7日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- INFO ON DENT GR
- 2025-080 (Turkish Medicines and Medical Devices Agency (TITCK))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.