N/A
N=50
Clinical Investigation of the F-Composite 2 System in Direct Filling Therapy
Dental Caries · Unsatisfactory or Defective Restoration of Tooth
Bottom Line
View on ClinicalTrials.gov: NCT03221660 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Percentage of Restored Teeth With Postoperative Sensitivity — 7 percentage restored hypersensitive teeth
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- F-Composite 2 system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ivoclar Vivadent AG
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Restored Teeth With Postoperative Sensitivity |
7 | — |
| SECONDARY Number of Restored Teeth With Loss of Vitality |
— | — |
| SECONDARY Replacement of Filling |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Indication for direct filling of Class I or II with permanent premolars or permanent molars
- replacement of insufficient fillings (e.g., due to edge caries, filling fracture, Lack of quality of the surface, lack of aesthetics, undesirable filling material, leaky edge, edge gap, etc.)
- extensive primary caries
- Vital tooth (cold test)
- One-, two- or three-surface fillings in the lateral tooth area, with a maximum of 25% single-faced (Class I) with antagonists.
- The occlusal area of the filling must be at least 1/3 of the total area of the filling tooth. This criterion is estimated.
- Patient wishes to receive care within the framework of the study (written consent after detailed elucidation and study of patient information).
- Maximum of 2 restorations per patient.
- Preoperative complaints on the tooth to be restored (maximum 3 on visual Analog scale (0 = complaint-free, 10 = maximum possible pain) to temperature or bite sensitivity
- Sufficient language skills
Exclusion Criteria
- Unfinished hygiene phase or poor oral hygiene
- Sufficient draining of the operating field is not possible
- Patients with proven allergy to one of the ingredients of the materials used
- Patient has allergies to local anesthetic agents Ultracain DS (active substance: articaine; Vasoconstrictor), if anesthesia is desired
- Patients with severe systemic diseases
- Devital or pulpitic teeth
- Periodontal insufficiency
- Supplements with cusp attachments
- open side bite
- missing antagonist
- Indication for direct capping
- Pregnancy (women of childbearing age receive a free pregnancy test for self application, the negative result of which is shown with her confirmed consent).
Data sourced from ClinicalTrials.gov (NCT03221660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.