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

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
F-Composite 2 system	F-Composite 2 system	Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the F-Composite 2 system.

Primary Outcome Measures

Name	Time	Method
Percentage of Restored Teeth With Postoperative Sensitivity	1 month	The postoperative sensitivity is assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, from 0 "no pain" to 10 "maximum pain") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable". A maximum of 10% postoperative hypersensitivities are defined as acceptable after one month.

Secondary Outcome Measures

Name	Time	Method
Replacement of Filling	2 years	maximum of 3 fillings which have to be replaced due to a lack of quality after 2 years
Number of Restored Teeth With Loss of Vitality	12 months	The loss of vitality of restored teeth is assessed by a cold stimuli test (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable". A maximum of 1 tooth with loss of vitality within 12 months is determined to be acceptable.