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

Primary Purpose

Dental Caries, Unsatisfactory or Defective Restoration of Tooth

Status
Completed
Phase
Not Applicable
Locations
Liechtenstein
Study Type
Interventional
Intervention
F-Composite 2 system
Sponsored by
Ivoclar Vivadent AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring filling material, polymerization

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Ivoclar Vivadent

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

F-Composite 2 system

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Replacement of Filling
maximum of 3 fillings which have to be replaced due to a lack of quality after 2 years

Full Information

First Posted
July 13, 2017
Last Updated
July 11, 2023
Sponsor
Ivoclar Vivadent AG
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1. Study Identification

Unique Protocol Identification Number
NCT03221660
Brief Title
Clinical Investigation of the F-Composite 2 System in Direct Filling Therapy
Official Title
Clinical Investigation of the F-Composite 2 System in Direct Filling Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 11, 2018 (Actual)
Primary Completion Date
April 3, 2018 (Actual)
Study Completion Date
July 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ivoclar Vivadent AG

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Unsatisfactory or Defective Restoration of Tooth
Keywords
filling material, polymerization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
F-Composite 2 system
Arm Type
Experimental
Arm Description
Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the F-Composite 2 system.
Intervention Type
Device
Intervention Name(s)
F-Composite 2 system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Restored Teeth With Postoperative Sensitivity
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Number of Restored Teeth With Loss of Vitality
Description
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.
Time Frame
12 months
Title
Replacement of Filling
Description
maximum of 3 fillings which have to be replaced due to a lack of quality after 2 years
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukas Enggist, Dr
Organizational Affiliation
dentist internal clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ivoclar Vivadent
City
Schaan
ZIP/Postal Code
9494
Country
Liechtenstein

12. IPD Sharing Statement

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

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