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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries; Unsatisfactory or Defective Restoration of Tooth
• Intervention / Treatment: Device: F-Composite 2 system

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Liechtenstein
  • Schaan, Liechtenstein, 9494
    • Ivoclar Vivadent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Restored Teeth With Postoperative Sensitivity	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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Restored Teeth With Loss of Vitality	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.	12 months
Replacement of Filling	maximum of 3 fillings which have to be replaced due to a lack of quality after 2 years	2 years

Collaborators and Investigators

• Sponsor: Ivoclar Vivadent AG
• Investigators: Principal Investigator: Lukas Enggist, Dr, dentist internal clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2018
• Primary Completion (Actual): April 3, 2018
• Study Completion (Actual): July 7, 2023

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: filling material, polymerization
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 621211

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No