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NCT Number: NCT07632443

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

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.

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Key information

Conditions

Tooth Loss Dentin Caries Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases Tooth Fractures Tooth Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University, Faculty of Dentistry, Department of Prosthodontics

Izmir, 35040, Turkey (Türkiye)

Location status: Recruiting

Location contact

Mine Dundar Comlekoglu, Professor

CONTACT

[email protected]

+90 (532) 552 74 16

Ozgur Yasar, MD, Spec.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Temporary Fixed Prosthesis (Tempo-CAD Monocolor PMMA)

Device

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.

Temporary Fixed Prosthesis (Tempo-CAD Monocolor SHT PMMA)

Device

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.

Temporary Fixed Prosthesis (Tempo-CAD Multicolor SHT PMMA)

Device

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.

Temporary Fixed Prosthesis (Print On - Cyclone Perma Resin)

Device

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.

Primary outcomes

  1. Success Rate of Temporary Fixed Restorations

    Time frame: 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.

  2. Survival Rate of Temporary Fixed Restorations

    Time frame: 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.

  3. Incidence of Clinical Complications

    Time frame: 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

  4. Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)

    Time frame: 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.

Secondary outcomes

  1. Clinical Evaluation of Masticatory Function (Occlusion Quality)

    Time frame: 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.

  2. Patient-Reported Masticatory Satisfaction

    Time frame: 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.

  3. Oral Health-Related Quality of Life (OHRQoL)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nurten Ozdenler, Sponsor Rep

CONTACT

[email protected]

+90 (232) 253 2577

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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