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

NCT03221660 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-04-13

Study results available
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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

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.

Sponsors & Collaborators

  • Ivoclar Vivadent AG

    lead INDUSTRY

Principal Investigators

  • Lukas Enggist, Dr · dentist internal clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-11
Primary Completion
2018-04-03
Completion
2023-07-07

Countries

  • Liechtenstein

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03221660 on ClinicalTrials.gov