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The purpose of this clinical trial is to measure the clinical outcomes of Tetric PowerFill Class I and II restorations cured in 3 seconds with the Bluephase PowerCure curing unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tetric PowerFill Class I and II restorations | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetric PowerFill | Device | Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| FDI 11 - Postoperative Hypersensitivity | assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Baseline |
| Pulp Integrity | Restored teeth are assessed by a cold air stimuli test (air syringe) by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") | Baseline |
| Overall Survival Rate | Restorations were examined by a dentist | Baseline |
| FDI 11 - Postoperative Hypersensitivity | assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 6 Month |
| Pulp Integrity | Restored teeth are assessed by a cold air stimuli test (air syringe) by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") | 6 Month |
| Overall Survival Rate | Restorations were examined by a dentist | 6 Month |
| FDI 11 - Postoperative Hypersensitivity | assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" |
| Measure | Description | Time Frame |
|---|---|---|
| FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity) | assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Baseline |
| FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathaniel Lawson, Dr | UAB School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB School of Dentistry | Birmingham | Alabama | 35294-0007 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tetric PowerFill Class I and II restorations | Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tetric PowerFill Class I and II restorations | Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | FDI 11 - Postoperative Hypersensitivity | assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Posted | Number | Restorations | Baseline | Restorations | Restorations |
|
|
36 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 | Tetric PowerFill Class I and II restorations | Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Restoration was replaced | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Team Leader Study Management | Ivoclar Vivadent AG | +4232353780 | patrizia.elkuch-hoch@ivoclar.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 | Aug 23, 2017 | Sep 26, 2025 | Prot_SAP_001.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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| 12 Month |
| Pulp Integrity | Restored teeth are assessed by a cold air stimuli test (air syringe) by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") | 12 Month |
| Overall Survival Rate | Restorations were examined by a dentist | 12 Month |
| FDI 11 - Postoperative Hypersensitivity | assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 24 Month |
| Pulp Integrity | Restored teeth are assessed by a cold air stimuli test (air syringe) by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") | 24 Month |
| Overall Survival Rate | Restorations were examined by a dentist | 24 Month |
| FDI 11 - Postoperative Hypersensitivity | assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 36 Month |
| Pulp Integrity | Restored teeth are assessed by a cold air stimuli test (air syringe) by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") | 36 Month |
| Overall Survival Rate | Restorations were examined by a dentist | 36 Month |
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" |
| 6 Month |
| FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity) | assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 12 Month |
| FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity) | assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 24 Month |
| FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity) | assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 36 Month |
| Restorations |
|
| 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 |
|
|
| Restorations |
|
|
| Primary | Pulp Integrity | Restored teeth are assessed by a cold air stimuli test (air syringe) by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") | Posted | Number | Restorations | Baseline | Restorations | Restorations |
|
|
|
| Primary | Overall Survival Rate | Restorations were examined by a dentist | Posted | Number | Restorations | Baseline | Restorations | Restorations |
|
|
|
| Primary | FDI 11 - Postoperative Hypersensitivity | assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Posted | Number | Restorations | 6 Month | Restorations | Restorations |
|
|
|
| Primary | Pulp Integrity | Restored teeth are assessed by a cold air stimuli test (air syringe) by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") | Posted | Number | Restorations | 6 Month | Restorations | Restorations |
|
|
|
| Primary | Overall Survival Rate | Restorations were examined by a dentist | Posted | Number | Restorations | 6 Month | Restorations | Restorations |
|
|
|
| Primary | FDI 11 - Postoperative Hypersensitivity | assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Posted | Number | Restorations | 12 Month | Restorations | Restorations |
|
|
|
| Primary | Pulp Integrity | Restored teeth are assessed by a cold air stimuli test (air syringe) by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") | Posted | Number | Restorations | 12 Month | Restorations | Restorations |
|
|
|
| Primary | Overall Survival Rate | Restorations were examined by a dentist | Posted | Number | Restorations | 12 Month | Restorations | Restorations |
|
|
|
| Primary | FDI 11 - Postoperative Hypersensitivity | assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Posted | Number | Restorations | 24 Month | Restorations | Restorations |
|
|
|
| Primary | Pulp Integrity | Restored teeth are assessed by a cold air stimuli test (air syringe) by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") | Posted | Number | Restorations | 24 Month | Restorations | Restorations |
|
|
|
| Primary | Overall Survival Rate | Restorations were examined by a dentist | Posted | Number | Restorations | 24 Month | Restorations | Restorations |
|
|
|
| Primary | FDI 11 - Postoperative Hypersensitivity | assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Posted | Number | Restorations | 36 Month | Restorations | Restorations |
|
|
|
| Primary | Pulp Integrity | Restored teeth are assessed by a cold air stimuli test (air syringe) by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") | Posted | Number | Restorations | 36 Month | Restorations | Restorations |
|
|
|
| Primary | Overall Survival Rate | Restorations were examined by a dentist | Posted | Number | Restorations | 36 Month | Restorations | Restorations |
|
|
|
| Secondary | FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity) | assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Posted | Number | Restorations | Baseline | Restorations | Restorations |
|
|
|
| Secondary | FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity) | assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Posted | Number | Restorations | 6 Month | Restorations | Restorations |
|
|
|
| Secondary | FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity) | assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Posted | Number | Restorations | 12 Month | Restorations | Restorations |
|
|
|
| Secondary | FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity) | assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Posted | Number | Restorations | 24 Month | Restorations | Restorations |
|
|
|
| Secondary | FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity) | assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Posted | Number | Restorations | 36 Month | Restorations | Restorations |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 2 |
| 39 |
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| Title | Measurements |
|---|---|
|
| VAS Score 7-8 |
|
| VAS Score 9-10 |
|
| Title | Measurements |
|---|---|
|
| FDI Score 4-5 |
|
| Title | Measurements |
|---|---|
|
| VAS Score 7-8 |
|
| VAS Score 9-10 |
|
| Title | Measurements |
|---|---|
|
| FDI Score 4-5 |
|
| Title | Measurements |
|---|---|
|
| VAS Score 7-8 |
|
| VAS Score 9-10 |
|
| Title | Measurements |
|---|---|
|
| FDI Score 4-5 |
|
| Title | Measurements |
|---|---|
|
| VAS Score 7-8 |
|
| VAS Score 9-10 |
|
| Title | Measurements |
|---|---|
|
| FDI Score 4-5 |
|
| Title | Measurements |
|---|---|
|
| VAS Score 7-8 |
|
| VAS Score 9-10 |
|
| Title | Measurements |
|---|---|
|
| FDI 2 - Surface staining: FDI Score 2-5 |
|
| FDI 3 - Color matching: FDI Score 1 |
|
| FDI 3 - Color matching: FDI Score 2 |
|
| FDI 3 - Color matching: FDI Score 3 |
|
| FDI 3 - Color matching: FDI Score 4-5 |
|
| FDI 5 - Material fracture: FDI Score 1 |
|
| FDI 5 - Material fracture: FDI Score 2-5 |
|
| FDI 7 - Occlusal wear: FDI Score 1 |
|
| FDI 7 - Occlusal wear: FDI Score 2-5 |
|
| FDI 13 - Tooth integrity: FDI Score 1 |
|
| FDI 13 - Tooth integrity: FDI Score 2-5 |
|
| Title | Measurements |
|---|---|
|
| FDI 2 - Surface staining: FDI Score 1 |
|
| FDI 2 - Surface staining: FDI Score 2-5 |
|
| FDI 3 - Color matching: FDI Score 1 |
|
| FDI 3 - Color matching: FDI Score 2 |
|
| FDI 3 - Color matching: FDI Score 3 |
|
| FDI 3 - Color matching: FDI Score 4-5 |
|
| FDI 5 - Material fracture: FDI Score 1 |
|
| FDI 5 - Material fracture: FDI Score 2-5 |
|
| FDI 7 - Occlusal wear: FDI Score 1 |
|
| FDI 7 - Occlusal wear: FDI Score 2-5 |
|
| FDI 13 - Tooth integrity: FDI Score 1 |
|
| FDI 13 - Tooth integrity: FDI Score 2-5 |
|
| Title | Measurements |
|---|---|
|
| FDI 2 - Surface staining: FDI Score 1 |
|
| FDI 2 - Surface staining: FDI Score 2 |
|
| FDI 2 - Surface staining: FDI Score 3-5 |
|
| FDI 3 - Color matching: FDI Score 1 |
|
| FDI 3 - Color matching: FDI Score 2 |
|
| FDI 3 - Color matching: FDI Score 3 |
|
| FDI 3 - Color matching: FDI Score 4-5 |
|
| FDI 5 - Material fracture: FDI Score 1 |
|
| FDI 5 - Material fracture: FDI Score 2-5 |
|
| FDI 7 - Occlusal wear: FDI Score 1 |
|
| FDI 7 - Occlusal wear: FDI Score 2-5 |
|
| FDI 13 - Tooth integrity: FDI Score 1 |
|
| FDI 13 - Tooth integrity: FDI Score 2-5 |
|
| Title | Measurements |
|---|---|
|
| FDI 2 - Surface staining: FDI Score 1 |
|
| FDI 2 - Surface staining: FDI Score 2 |
|
| FDI 2 - Surface staining: FDI Score 3-5 |
|
| FDI 3 - Color matching: FDI Score 1 |
|
| FDI 3 - Color matching: FDI Score 2 |
|
| FDI 3 - Color matching: FDI Score 3 |
|
| FDI 3 - Color matching: FDI Score 4-5 |
|
| FDI 5 - Material fracture: FDI Score 1 |
|
| FDI 5 - Material fracture: FDI Score 2-5 |
|
| FDI 7 - Occlusal wear: FDI Score 1 |
|
| FDI 7 - Occlusal wear: FDI Score 2 |
|
| FDI 7 - Occlusal wear: FDI Score 3-5 |
|
| FDI 13 - Tooth integrity: FDI Score 1 |
|
| FDI 13 - Tooth integrity: FDI Score 2-5 |
|
| Title | Measurements |
|---|---|
|
| FDI 2 - Surface staining: FDI Score 1 |
|
| FDI 2 - Surface staining: FDI Score 2-5 |
|
| FDI 3 - Color matching: FDI Score 1 |
|
| FDI 3 - Color matching: FDI Score 2 |
|
| FDI 3 - Color matching: FDI Score 3 |
|
| FDI 3 - Color matching: FDI Score 4-5 |
|
| FDI 5 - Material fracture: FDI Score 1 |
|
| FDI 5 - Material fracture: FDI Score 2-5 |
|
| FDI 7 - Occlusal wear: FDI Score 1 |
|
| FDI 7 - Occlusal wear: FDI Score 2 |
|
| FDI 7 - Occlusal wear: FDI Score 3-5 |
|
| FDI 13 - Tooth integrity: FDI Score 1 |
|
| FDI 13 - Tooth integrity: FDI Score 2-5 |
|