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

Ivoclar Vivadent

Status: Completed

Conditions: Dental Caries; Unsatisfactory or Defective Restoration of Tooth

Treatments: Device: F-Composite 2 system

Study type: Interventional

Funder types: Industry

Identifiers

NCT03221660

621211

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

F-Composite 2 system

Experimental group

Description:

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

Treatment:

Device: F-Composite 2 system