PMCF Study on The Performance and Safety of ON DENT® PMMA Discs/Blocks and Resin Products for Temporary Restorations
7 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
120
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Nurten Ozdenler, Sponsor Rep
- Número de teléfono: +90 (232) 253 2577
- Correo electrónico: nurten@on-dent.com
Ubicaciones de estudio
-
-
-
Izmir, Turquía (Türkiye), 35040
- Reclutamiento
- Ege University, Faculty of Dentistry, Department of Prosthodontics
-
Contacto:
- Mine Dundar Comlekoglu, Professor
- Número de teléfono: +90 (532) 552 74 16
- Correo electrónico: minedundar@yahoo.com
-
Sub-Investigador:
- Ozgur Yasar, MD, Spec.
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Success Rate of Temporary Fixed Restorations
Periodo de tiempo: 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
Periodo de tiempo: 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).
|
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Incidence of Clinical Complications
Periodo de tiempo: 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).
|
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Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Periodo de tiempo: 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).
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient-Reported Masticatory Satisfaction
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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Baseline (pre-treatment at Visit 1) and at the final follow-up/definitive delivery checkpoint (Visit 5/up to 6 months).
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Clinical Evaluation of Masticatory Function (Occlusion Quality)
Periodo de tiempo: 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).
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Mine Dundar Comlekoglu, Ege University, Faculty of Dentistry, Department of Prosthodontics
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
5 de diciembre de 2025
Finalización primaria (Estimado)
4 de marzo de 2027
Finalización del estudio (Estimado)
4 de julio de 2027
Fechas de registro del estudio
Enviado por primera vez
2 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
2 de junio de 2026
Publicado por primera vez (Actual)
8 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- INFO ON DENT GR
- 2025-080 (Turkish Medicines and Medical Devices Agency (TITCK))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .