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Clinical investigation of the 3s PowerCure Product System in direct filling therapy

Clinical investigation of the 3s PowerCure Product System in direct filling therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00023955
Enrollment
66
Registered
2021-01-21
Start date
2019-12-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K02

Interventions

Group 1: 3s PowerCure (Tetric PowerFill/ Tetric PowerFlow): Fast-curing composite dental filling Group 2: Tetric EvoCeram: Conventional Composite - Dental Filling

Sponsors

Ivoclar Vivadent AG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

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

MeasureTime 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

MeasureTime frame
Quality of restorations (according to FDI criteria), Vitality of treated teeth

Countries

Germany

Contacts

Public ContactMatthias J.

Philipps-Universität-Marburg

matthias.roggendorf@staff.uni-marburg.de0049-6421-58-65621

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026