Clinical trial NCT03221660: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Unsatisfactory or Defective Restoration of Tooth
Keywords: filling material, polymerization
Lead sponsor: Ivoclar Vivadent AG
Sponsor class: INDUSTRY
First posted: 2017-07-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Percentage of Restored Teeth With Postoperative Sensitivity
timeFrame: 1 month
Secondary outcomes:
measure: Number of Restored Teeth With Loss of Vitality
timeFrame: 12 months
measure: Replacement of Filling
timeFrame: 2 years
Other outcomes:
measure: FDI 1 Surface Luster, FDI Score 1-5
timeFrame: 60 months
measure: FDI 2 Surface Staining, FDI Score 1-5
timeFrame: 60 month
measure: FDI 3 Translucency, FDI Score 1-5
timeFrame: 60 month
measure: FDI 5 Retention/Fracture of Restorations, FDI Score 1-5
timeFrame: 60 month
measure: FDI 6 Marginal Adaption, FDI Score 1-5
timeFrame: 60 month
measure: FDI 10 Patient's View, FDI Scire 1-5
timeFrame: 60 month
measure: FDI 11 Postoperative Hypersensitivity and Tooth Vitality, FDI Scores 1-5
timeFrame: 60 month
measure: FDI 12 Recurrence of Caries (CAR), Erosion, Abfraction, FDI Scores 1-5
timeFrame: 60 month
measure: FDI 13 Tooth Integrity, FDI Scores 1-5
timeFrame: 60 month
Locations:
city: Schaan
country: Liechtenstein
facility: Ivoclar Vivadent
Study officials:
affiliation: dentist internal clinic
name: Lukas Enggist, Dr
role: PRINCIPAL_INVESTIGATOR
References: