Trial Outcomes & Findings for Clinical Evaluation of a Bulk Fill Resin Composite (NCT NCT04686422)
NCT ID: NCT04686422
Last Updated: 2025-10-23
Results Overview
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"
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
Baseline
Results posted on
2025-10-23
Participant Flow
Unit of analysis: Restorations
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
39 68
|
|
Overall Study
6 Month
|
37 66
|
|
Overall Study
12 Month
|
34 62
|
|
Overall Study
24 Month
|
29 52
|
|
Overall Study
COMPLETED
|
23 40
|
|
Overall Study
NOT COMPLETED
|
16 28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Evaluation of a Bulk Fill Resin Composite
Baseline characteristics by cohort
| Measure |
Tetric PowerFill Class I and II restorations
n=68 Restorations
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
Age, Customized
<= 18 years
|
0 Participants
n=39 Participants
|
|
Age, Customized
Between 18 and 90 years
|
39 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Baselineassessed 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"
Outcome measures
| Measure |
Tetric PowerFill Class I and II restorations
n=68 Restorations
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
FDI 11 - Postoperative Hypersensitivity
FDI Score 1
|
55 Restorations
|
|
FDI 11 - Postoperative Hypersensitivity
FDI Score 2
|
10 Restorations
|
|
FDI 11 - Postoperative Hypersensitivity
FDI Score 3
|
3 Restorations
|
|
FDI 11 - Postoperative Hypersensitivity
FDI Score 4-5
|
0 Restorations
|
PRIMARY outcome
Timeframe: BaselineRestored 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")
Outcome measures
| Measure |
Tetric PowerFill Class I and II restorations
n=68 Restorations
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
Pulp Integrity
VAS Score 0-1
|
60 Restorations
|
|
Pulp Integrity
VAS Score 2-3
|
5 Restorations
|
|
Pulp Integrity
VAS Score 4-6
|
2 Restorations
|
|
Pulp Integrity
VAS Score 7-8
|
0 Restorations
|
|
Pulp Integrity
VAS Score 9-10
|
1 Restorations
|
PRIMARY outcome
Timeframe: BaselineRestorations were examined by a dentist
Outcome measures
| Measure |
Tetric PowerFill Class I and II restorations
n=68 Restorations
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
Overall Survival Rate
|
68 Restorations
|
PRIMARY outcome
Timeframe: 6 Monthassessed 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"
Outcome measures
| Measure |
Tetric PowerFill Class I and II restorations
n=66 Restorations
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
FDI 11 - Postoperative Hypersensitivity
FDI Score 4-5
|
0 Restorations
|
|
FDI 11 - Postoperative Hypersensitivity
FDI Score 1
|
60 Restorations
|
|
FDI 11 - Postoperative Hypersensitivity
FDI Score 2
|
3 Restorations
|
|
FDI 11 - Postoperative Hypersensitivity
FDI Score 3
|
3 Restorations
|
PRIMARY outcome
Timeframe: 6 MonthRestored 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")
Outcome measures
| Measure |
Tetric PowerFill Class I and II restorations
n=66 Restorations
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
Pulp Integrity
VAS Score 0-1
|
64 Restorations
|
|
Pulp Integrity
VAS Score 2-3
|
0 Restorations
|
|
Pulp Integrity
VAS Score 4-6
|
0 Restorations
|
|
Pulp Integrity
VAS Score 7-8
|
0 Restorations
|
|
Pulp Integrity
VAS Score 9-10
|
2 Restorations
|
PRIMARY outcome
Timeframe: 6 MonthRestorations were examined by a dentist
Outcome measures
| Measure |
Tetric PowerFill Class I and II restorations
n=66 Restorations
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
Overall Survival Rate
|
66 Restorations
|
PRIMARY outcome
Timeframe: 12 Monthassessed 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"
Outcome measures
| Measure |
Tetric PowerFill Class I and II restorations
n=62 Restorations
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
FDI 11 - Postoperative Hypersensitivity
FDI Score 1
|
59 Restorations
|
|
FDI 11 - Postoperative Hypersensitivity
FDI Score 2
|
2 Restorations
|
|
FDI 11 - Postoperative Hypersensitivity
FDI Score 3
|
1 Restorations
|
|
FDI 11 - Postoperative Hypersensitivity
FDI Score 4-5
|
0 Restorations
|
PRIMARY outcome
Timeframe: 12 MonthRestored 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")
Outcome measures
| Measure |
Tetric PowerFill Class I and II restorations
n=62 Restorations
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
Pulp Integrity
VAS Score 0-1
|
60 Restorations
|
|
Pulp Integrity
VAS Score 2-3
|
0 Restorations
|
|
Pulp Integrity
VAS Score 4-6
|
2 Restorations
|
|
Pulp Integrity
VAS Score 7-8
|
0 Restorations
|
|
Pulp Integrity
VAS Score 9-10
|
0 Restorations
|
PRIMARY outcome
Timeframe: 12 MonthRestorations were examined by a dentist
Outcome measures
| Measure |
Tetric PowerFill Class I and II restorations
n=62 Restorations
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
Overall Survival Rate
|
62 Restorations
|
PRIMARY outcome
Timeframe: 24 Monthassessed 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"
Outcome measures
| Measure |
Tetric PowerFill Class I and II restorations
n=52 Restorations
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
FDI 11 - Postoperative Hypersensitivity
FDI Score 1
|
50 Restorations
|
|
FDI 11 - Postoperative Hypersensitivity
FDI Score 2
|
2 Restorations
|
|
FDI 11 - Postoperative Hypersensitivity
FDI Score 3
|
0 Restorations
|
|
FDI 11 - Postoperative Hypersensitivity
FDI Score 4-5
|
0 Restorations
|
PRIMARY outcome
Timeframe: 24 MonthRestored 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")
Outcome measures
| Measure |
Tetric PowerFill Class I and II restorations
n=52 Restorations
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
Pulp Integrity
VAS Score 0-1
|
49 Restorations
|
|
Pulp Integrity
VAS Score 2-3
|
3 Restorations
|
|
Pulp Integrity
VAS Score 4-6
|
0 Restorations
|
|
Pulp Integrity
VAS Score 7-8
|
0 Restorations
|
|
Pulp Integrity
VAS Score 9-10
|
0 Restorations
|
PRIMARY outcome
Timeframe: 24 MonthRestorations were examined by a dentist
Outcome measures
| Measure |
Tetric PowerFill Class I and II restorations
n=52 Restorations
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
Overall Survival Rate
Survived
|
51 Restorations
|
|
Overall Survival Rate
Failed
|
1 Restorations
|
PRIMARY outcome
Timeframe: 36 Monthassessed 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"
Outcome measures
| Measure |
Tetric PowerFill Class I and II restorations
n=40 Restorations
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
FDI 11 - Postoperative Hypersensitivity
FDI Score 1
|
40 Restorations
|
|
FDI 11 - Postoperative Hypersensitivity
FDI Score 2
|
0 Restorations
|
|
FDI 11 - Postoperative Hypersensitivity
FDI Score 3
|
0 Restorations
|
|
FDI 11 - Postoperative Hypersensitivity
FDI Score 4-5
|
0 Restorations
|
PRIMARY outcome
Timeframe: 36 MonthRestored 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")
Outcome measures
| Measure |
Tetric PowerFill Class I and II restorations
n=40 Restorations
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
Pulp Integrity
VAS Score 0-1
|
40 Restorations
|
|
Pulp Integrity
VAS Score 2-3
|
0 Restorations
|
|
Pulp Integrity
VAS Score 4-6
|
0 Restorations
|
|
Pulp Integrity
VAS Score 7-8
|
0 Restorations
|
|
Pulp Integrity
VAS Score 9-10
|
0 Restorations
|
PRIMARY outcome
Timeframe: 36 MonthRestorations were examined by a dentist
Outcome measures
| Measure |
Tetric PowerFill Class I and II restorations
n=40 Restorations
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
Overall Survival Rate
Survived
|
38 Restorations
|
|
Overall Survival Rate
Failed
|
2 Restorations
|
SECONDARY outcome
Timeframe: Baselineassessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
Outcome measures
| Measure |
Tetric PowerFill Class I and II restorations
n=68 Restorations
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 1 - Surface luster: FDI Score 1
|
68 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 1 - Surface luster: FDI Score 2-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 2 - Surface staining: FDI Score 1
|
68 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 2 - Surface staining: FDI Score 2-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 3 - Color matching: FDI Score 1
|
57 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 3 - Color matching: FDI Score 2
|
8 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 3 - Color matching: FDI Score 3
|
3 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 3 - Color matching: FDI Score 4-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 5 - Material fracture: FDI Score 1
|
68 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 5 - Material fracture: FDI Score 2-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 7 - Occlusal wear: FDI Score 1
|
68 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 7 - Occlusal wear: FDI Score 2-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 13 - Tooth integrity: FDI Score 1
|
68 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 13 - Tooth integrity: FDI Score 2-5
|
0 Restorations
|
SECONDARY outcome
Timeframe: 6 Monthassessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
Outcome measures
| Measure |
Tetric PowerFill Class I and II restorations
n=66 Restorations
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 1 - Surface luster: FDI Score 1
|
28 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 1 - Surface luster: FDI Score 2
|
38 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 1 - Surface luster: FDI Score 3-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 2 - Surface staining: FDI Score 1
|
66 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 2 - Surface staining: FDI Score 2-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 3 - Color matching: FDI Score 1
|
61 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 3 - Color matching: FDI Score 2
|
3 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 3 - Color matching: FDI Score 3
|
2 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 3 - Color matching: FDI Score 4-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 5 - Material fracture: FDI Score 1
|
66 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 5 - Material fracture: FDI Score 2-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 7 - Occlusal wear: FDI Score 1
|
66 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 7 - Occlusal wear: FDI Score 2-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 13 - Tooth integrity: FDI Score 1
|
66 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 13 - Tooth integrity: FDI Score 2-5
|
0 Restorations
|
SECONDARY outcome
Timeframe: 12 Monthassessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
Outcome measures
| Measure |
Tetric PowerFill Class I and II restorations
n=62 Restorations
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 1 - Surface luster: FDI Score 1
|
25 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 1 - Surface luster: FDI Score 2
|
37 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 1 - Surface luster: FDI Score 3-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 2 - Surface staining: FDI Score 1
|
59 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 2 - Surface staining: FDI Score 2
|
3 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 2 - Surface staining: FDI Score 3-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 3 - Color matching: FDI Score 1
|
59 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 3 - Color matching: FDI Score 2
|
3 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 3 - Color matching: FDI Score 3
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 3 - Color matching: FDI Score 4-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 5 - Material fracture: FDI Score 1
|
62 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 5 - Material fracture: FDI Score 2-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 7 - Occlusal wear: FDI Score 1
|
62 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 7 - Occlusal wear: FDI Score 2-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 13 - Tooth integrity: FDI Score 1
|
62 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 13 - Tooth integrity: FDI Score 2-5
|
0 Restorations
|
SECONDARY outcome
Timeframe: 24 Monthassessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
Outcome measures
| Measure |
Tetric PowerFill Class I and II restorations
n=52 Restorations
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 1 - Surface luster: FDI Score 3-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 2 - Surface staining: FDI Score 1
|
48 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 2 - Surface staining: FDI Score 2
|
4 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 2 - Surface staining: FDI Score 3-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 3 - Color matching: FDI Score 1
|
51 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 3 - Color matching: FDI Score 2
|
1 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 3 - Color matching: FDI Score 3
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 3 - Color matching: FDI Score 4-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 5 - Material fracture: FDI Score 1
|
52 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 5 - Material fracture: FDI Score 2-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 7 - Occlusal wear: FDI Score 1
|
50 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 7 - Occlusal wear: FDI Score 2
|
2 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 7 - Occlusal wear: FDI Score 3-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 13 - Tooth integrity: FDI Score 1
|
52 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 13 - Tooth integrity: FDI Score 2-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 1 - Surface luster: FDI Score 1
|
26 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 1 - Surface luster: FDI Score 2
|
26 Restorations
|
SECONDARY outcome
Timeframe: 36 Monthassessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
Outcome measures
| Measure |
Tetric PowerFill Class I and II restorations
n=40 Restorations
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 1 - Surface luster: FDI Score 1
|
12 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 1 - Surface luster: FDI Score 2
|
28 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 1 - Surface luster: FDI Score 3-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 2 - Surface staining: FDI Score 1
|
40 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 2 - Surface staining: FDI Score 2-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 3 - Color matching: FDI Score 1
|
35 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 3 - Color matching: FDI Score 2
|
5 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 3 - Color matching: FDI Score 3
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 3 - Color matching: FDI Score 4-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 5 - Material fracture: FDI Score 1
|
40 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 5 - Material fracture: FDI Score 2-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 7 - Occlusal wear: FDI Score 1
|
36 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 7 - Occlusal wear: FDI Score 2
|
4 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 7 - Occlusal wear: FDI Score 3-5
|
0 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 13 - Tooth integrity: FDI Score 1
|
40 Restorations
|
|
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
FDI 13 - Tooth integrity: FDI Score 2-5
|
0 Restorations
|
Adverse Events
Tetric PowerFill Class I and II restorations
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tetric PowerFill Class I and II restorations
n=39 participants at risk
Tetric PowerFill: Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
|
|---|---|
|
General disorders
Restoration was replaced
|
5.1%
2/39 • Number of events 2 • 36 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60