K02
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Age: 18-75 years • 40-60% women, 40-60% men • Indication for two comparable direct fillings of class I or II in premolars or first and second molars • Cavity width must be at least half of the cusp tip distance • Patient wishes to be treated within the scope of the study (written informed consent after detailed discussion) • 2 restorations in different quadrants per patient, e.g. 25 and 47 (extended split-mouth design) • Replacement of insufficient fillings • Extensive primary caries • Vital teeth, regular sensitivity • Sufficient language skills
Exclusion criteria
Exclusion criteria: • Incomplete hygiene phase or poor oral hygiene • Achieving a dry working field not possible • Patients with a proven allergy to one of the ingredients • Patients with severe systemic diseases • Non-vital or pulpitic study teeth (preoperative VAS >3) • Generalized hypersensitivity • Periodontally insufficient dentition • Restorations with cusp abutments • Laterally open bite • Missing antagonist, non-occlusion • Bruxism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| What: Post-operative sensitivity When: after Baseline (7 days), 6 months, 12 months, 24 months and 36 months) How: assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of restorations (according to FDI criteria), Vitality of treated teeth | — |
Countries
Germany
Contacts
Philipps-Universität-Marburg