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

NCT07632443 | Recruiting

• 2 other identifiers: INFO ON DENT GR2025-080
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tooth Loss; Tooth Fractures; Dentin Caries

Keywords

Post-Market Clinical Follow-Up (PMCF); Temporary Dental Restoration; Dental Prosthetics; Temporary Crown; Temporary Bridge; PMMA; Dental Resin; CAD/CAM Dentistry; Revised FDI Criteria

Outcome Measures

Primary Outcomes (4)

• Success Rate of Temporary Fixed Restorations

  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

  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

  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)

  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).

Secondary Outcomes (3)

• 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).

• Patient-Reported Masticatory Satisfaction

  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)

  Baseline (pre-treatment at Visit 1) and at the final follow-up/definitive delivery checkpoint (Visit 5/up to 6 months).

Study Arms (4)

MONOCOLOR PMMA

EXPERIMENTAL

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.

Device: Temporary Fixed Prosthesis (Tempo-CAD Monocolor PMMA)

MONOCOLOR SHT PMMA

EXPERIMENTAL

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.

Device: Temporary Fixed Prosthesis (Tempo-CAD Monocolor SHT PMMA)

MULTICOLOR SHT PMMA

EXPERIMENTAL

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.

Device: Temporary Fixed Prosthesis (Tempo-CAD Multicolor SHT PMMA)

3D Printer Resin

EXPERIMENTAL

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.

Device: Temporary Fixed Prosthesis (Print On - Cyclone Perma Resin)

Interventions

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.

MONOCOLOR PMMA

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.

MONOCOLOR SHT PMMA

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.

MULTICOLOR SHT PMMA

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.

3D Printer Resin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Ege University, Faculty of Dentistry, Department of Prosthodontics

Izmir, 35040, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Tooth Loss; Tooth Fractures

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Tooth Injuries; Wounds and Injuries

Study Officials

• Mine Dundar Comlekoglu

  Ege University, Faculty of Dentistry, Department of Prosthodontics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nurten Ozdenler, Sponsor Rep

CONTACT

+90 (232) 253 2577; nurten@on-dent.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This PMCF study employs a multi-arm, parallel design to independently evaluate the clinical performance and safety of temporary crown and bridge restorations fabricated from four distinct device models (n=30 per cohort). While participants are randomly assigned to ensure an unbiased distribution across the four study arms, each arm serves as an independent observational cohort representing a specific material composition and manufacturing methodology (milled PMMA variations vs. 3D-printed liquid resin). Statistical evaluations will be performed independently for each of the four groups using descriptive, longitudinal, and survival statistics. No between-arm hypothesis testing or direct cross-group statistical comparisons are intended, as the primary objective is to independently gather real-world evidence for each individual medical device.

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: December 5, 2025
• Primary Completion (Estimated): March 4, 2027
• Study Completion (Estimated): July 4, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)