NCT03221660

Clinical Investigation of the F-Composite 2 System in Direct Filling Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Ivoclar Vivadent AG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the clinical performance of F-Composite 2 system in Class I and Class II cavities in permanent teeth. The materials of the system can be polymerized in short time with a curing light which is part of the system. The study will be carried out as a prospective study, with evaluation of the restorations after 7-10 days (baseline), at 6 months, at 12 months, at 24 months and 60 months according to defined criteria.

Conditions

• Dental Caries
• Unsatisfactory or Defective Restoration of Tooth

Interventions

Type	Name	Description
DEVICE	F-Composite 2 system	Procedures will be done using local anesthesia (if the patients wants that). The cavity is prepared according to the principles of the adhesive technique. First the adhesive will be applied and polymerized, afterwards the flowable resin-based restorative material will be applied and polymerized and then the sculptable resin-based restorative material will be applied and polymerized; all materials will be light-cured within short time with an experimental curing light.

Timeline

• Start date: 2018-01-11
• Primary completion: 2018-04-03
• Completion: 2023-07-07
• First posted: 2017-07-18
• Last updated: 2025-04-13
• Results posted: 2020-12-16

Locations

1 site across 1 country: Liechtenstein