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

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.

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.

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

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.

Clinical Evaluation of Masticatory Function (Occlusion Quality)

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.

Patient-Reported Masticatory Satisfaction

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.

Oral Health-Related Quality of Life (OHRQoL)

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.