Dental Caries Clinical Trial
Official title:
Clinical Investigation of the F-Composite 2 System in Direct Filling Therapy
NCT number | NCT03221660 |
Other study ID # | 621211 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 11, 2018 |
Est. completion date | July 7, 2023 |
Verified date | July 2023 |
Source | Ivoclar Vivadent AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | July 7, 2023 |
Est. primary completion date | April 3, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Liechtenstein | Ivoclar Vivadent | Schaan |
Lead Sponsor | Collaborator |
---|---|
Ivoclar Vivadent AG |
Liechtenstein,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Replacement of Filling | maximum of 3 fillings which have to be replaced due to a lack of quality after 2 years | 2 years |
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