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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| FDI 1 Surface Luster, FDI Score 1-5 | assessed on patient teeth (comparing surface of filling with enamel) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 60 months |
| FDI 2 Surface Staining, FDI Score 1-5 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lukas Enggist, Dr | dentist internal clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ivoclar Vivadent | Schaan | 9494 | Liechtenstein |
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| ID | Title | Description |
|---|---|---|
| FG000 | F-Composite 2 System | 75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling. F-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | F-Composite 2 System | 75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling. F-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage restored hypersensitive teeth | 1 month | Teeth | Teeth |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Long-term hypersensitivity | General disorders | Systematic Assessment | Fillings needed to be replaced due to long-term hypersensitivity. It is generally related to this type of clinical procedure and might also be dependent on the applied light intensity, the used adhesive or the backstory of the tooth. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. med. dent. Lukas Enggist, Dentist internal clinic (Principal Investigator) | Ivoclar Vivadent AG | +423 235 34 46 | lukas.enggist@ivoclarvivadent.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2020 | Oct 9, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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|
| Replacement of Filling | maximum of 3 fillings which have to be replaced due to a lack of quality after 2 years | 2 years |
assessed on patient teeth by checking surface staining of restoration following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
| 60 month |
| FDI 3 Translucency, FDI Score 1-5 | assessed on patient teeth by checking differences in shade and translucency following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 60 month |
| FDI 5 Retention/Fracture of Restorations, FDI Score 1-5 | assessed on patient teeth (checking irestorations for fractures, cracks, small hairline cracks, chip fractures, material damage) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 60 month |
| FDI 6 Marginal Adaption, FDI Score 1-5 | assessed on patient teeth (checking for hamonious outline, gaps and white/discolored lines)) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 60 month |
| FDI 10 Patient's View, FDI Scire 1-5 | assessed by discussion with the patient (satisfied with esthetics and function) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 60 month |
| FDI 11 Postoperative Hypersensitivity and Tooth Vitality, FDI Scores 1-5 | Hypersensitivity was assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable". Tooth vtality assessed by a cold stimuli test on the patient teeth (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 60 month |
| FDI 12 Recurrence of Caries (CAR), Erosion, Abfraction, FDI Scores 1-5 | assessed on patient teeth (primary caries, areas of demineralization erosion or abfraction)) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 60 month |
| FDI 13 Tooth Integrity, FDI Scores 1-5 | assessed on patient teeth by checking tooth integrity (looking for enamel cracks, tooth fractures) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 60 month |
| Teeth |
|
| Participants |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | Teeth | Teeth |
|
|
|
|
| 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. | The participants analyzed and number of teeth (units) analyzed differs from the number of participants and units assigned to the arm as 1 participant with 2 fillings did not attend the 12-month recall. | Posted | Number | teeth | 12 months | Teeth | Teeth |
|
|
|
| Secondary | Replacement of Filling | maximum of 3 fillings which have to be replaced due to a lack of quality after 2 years | Posted | Number | replaced fillings due to quality | 2 years | Teeth | Teeth |
|
|
|
| Other Pre-specified | FDI 1 Surface Luster, FDI Score 1-5 | assessed on patient teeth (comparing surface of filling with enamel) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed | Posted | Number | Teeth | 60 months | teeth | teeth |
|
|
|
| Other Pre-specified | FDI 2 Surface Staining, FDI Score 1-5 | assessed on patient teeth by checking surface staining of restoration following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed | Posted | Number | teeth | 60 month | Teeth | Teeth |
|
|
|
| Other Pre-specified | FDI 3 Translucency, FDI Score 1-5 | assessed on patient teeth by checking differences in shade and translucency following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed | Posted | Number | Teeth | 60 month | Teeth | Teeth |
|
|
|
| Other Pre-specified | FDI 5 Retention/Fracture of Restorations, FDI Score 1-5 | assessed on patient teeth (checking irestorations for fractures, cracks, small hairline cracks, chip fractures, material damage) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed | Posted | Number | Teeth | 60 month | Teeth | Teeth |
|
|
|
| Other Pre-specified | FDI 6 Marginal Adaption, FDI Score 1-5 | assessed on patient teeth (checking for hamonious outline, gaps and white/discolored lines)) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed | Posted | Number | Teeth | 60 month | Teeth | Teeth |
|
|
|
| Other Pre-specified | FDI 10 Patient's View, FDI Scire 1-5 | assessed by discussion with the patient (satisfied with esthetics and function) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed | Posted | Number | Teeth | 60 month | Teeth | Teeth |
|
|
|
| Other Pre-specified | FDI 11 Postoperative Hypersensitivity and Tooth Vitality, FDI Scores 1-5 | Hypersensitivity was assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable". Tooth vtality assessed by a cold stimuli test on the patient teeth (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed | Posted | Number | Teeth | 60 month | Teeth | Teeth |
|
|
|
| Other Pre-specified | FDI 12 Recurrence of Caries (CAR), Erosion, Abfraction, FDI Scores 1-5 | assessed on patient teeth (primary caries, areas of demineralization erosion or abfraction)) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed | Posted | Number | Teeth | 60 month | Teeth | Teeth |
|
|
|
| Other Pre-specified | FDI 13 Tooth Integrity, FDI Scores 1-5 | assessed on patient teeth by checking tooth integrity (looking for enamel cracks, tooth fractures) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed | Posted | Number | Teeth | 60 month | Teeth | Teeth |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 4 |
| 50 |
|
| Unrelated: Fracture of disto-lingual cusp next to study tooth | General disorders | Systematic Assessment | The fracture was partly at the border to the study restoration. But the restoration remained intact and was available for the 60-month recall. This adverse event is unrelated to the clinical procedure and to the investigational device itself. |
|
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| Title | Measurements |
|---|---|
|
| FDI 1 Surface Luster, FDI Score 4-5 |
|
| Title | Measurements |
|---|---|
|
| FDI 2 Surface Staining, FDI Score 4-5 |
|
| Title | Measurements |
|---|---|
|
|
| FDI 5 Fracture of material and retention, FDI Score 4-5 |
|
| Title | Measurements |
|---|---|
|
| FDI 6 Marginal Gap, FDI Score 4-5 |
|
|
| Title | Measurements |
|---|---|
|
| FDI 13 Tooth integrity, FDI Score 5 |
|