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

NCT03221660 | Completed Results

• 1 other identifier: 621211
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Unsatisfactory or Defective Restoration of Tooth

Keywords

filling material, polymerization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Restored Teeth With Loss of Vitality

  12 months

• Replacement of Filling

  2 years

Other Outcomes (9)

• FDI 1 Surface Luster, FDI Score 1-5

  60 months

• FDI 2 Surface Staining, FDI Score 1-5

  60 month

• FDI 3 Translucency, FDI Score 1-5

  60 month

Study Arms (1)

F-Composite 2 system

EXPERIMENTAL

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

Interventions

F-Composite 2 system DEVICE

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.

F-Composite 2 system

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ivoclar Vivadent AG: lead

Study Sites (1)

Ivoclar Vivadent

Schaan, 9494, Liechtenstein

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr. med. dent. Lukas Enggist, Dentist internal clinic (Principal Investigator)
• Organization: Ivoclar Vivadent AG

lukas.enggist@ivoclarvivadent.com

+423 235 34 46

Study Officials

• Lukas Enggist, Dr

  dentist internal clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 18, 2017
• Study Start: January 11, 2018
• Primary Completion: April 3, 2018
• Study Completion: July 7, 2023
• Last Updated: April 13, 2025
• Results First Posted: December 16, 2020

Record last verified: 2025-03

Locations

LI (1)