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

NCT ID: NCT03221660

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-11
• Study Completion Date: 2023-07-07

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

F-Composite 2 system

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ivoclar Vivadent AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lukas Enggist, Dr

Role: PRINCIPAL_INVESTIGATOR

dentist internal clinic

Locations

Ivoclar Vivadent

Schaan, , Liechtenstein

Countries

Liechtenstein

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

621211

Identifier Type: -

Identifier Source: org_study_id