K02
Conditions
Interventions
Group 1: Each patient receives treatment for a Class II cavity in the posterior region using the test material Stela (modified split-mouth design). The material is assigned to the respective tooth at
Sponsors
Klinik für Zahnerhaltungskunde und Parodontologie
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: - Good general health (ASA 1 or 2) - The patient requires Class II restoration on at least two teeth. - The study teeth are vital (positive sensitivity test). - Oral hygiene is sufficient (PBI < 30%). - Each of the study restorations is load-bearing and has at least one approximal contact, but not to another study restoration. - The study participant is participating in the study voluntarily, has given their written consent to participate after receiving detailed information, and is available for follow-up examinations within the next three years.
Exclusion criteria
Exclusion criteria: - Known allergies or intolerances to the ingredients of the filling materials used. - Increased tooth mobility (more than grade I) - Periodontal probing depths > 5.5 mm (CPITN probe) - Study teeth show signs of pulpitis - Opening of the pulp during caries excavation/treatment - Existing suspicion of craniomandibular dysfunction (CMD short finding >1 according to Ahlers and Jakstat) - Presence of excessive dietary or environmental acid damage (erosion) and/or existing suspicion of an eating disorder (BEWE 0-I). - Pregnancy or breastfeeding at the time of study participation - The study participant is participating in any other study at the time of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The “Clinical Polymerization Score” includes the modified FDI criteria “F1: material fracture and retention, F2: marginal adaptation, B1: secondary caries, B2: condition of the tooth substance at the restoration margin, and B3: postoperative hypersensitivity” (each individual score 1–5, Clinical Polymerization Score 5–25) and is assessed at the time points T0 (baseline), T0.5 (6 months ± 1 month), T1 (1 year ± 2 months), T2 (2 years ± 2 months), and T3 (3 years ± 2 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical success of the restorations (individual score 1 [clinically excellent] – 3 [clinically satisfactory] in all parameters according to modified FDI criteria) Survival of the restorations (individual score 1 [clinically excellent] – 4 [clinically unsatisfactory but repairable] in all parameters according to modified FDI criteria) Progression of clinical parameters over time (based on the individual modified FDI criteria) | — |
Countries
Germany
Contacts
Public ContactFabian Cieplik
Klinik für Zahnerhaltungskunde und Parodontologie
Outcome results
None listed