Trial Outcomes & Findings for Prospective, Split-mouth, Comparative Study to Compare Clinical Outcomes of Two Different Posterior Composite (NCT NCT04708223)
NCT ID: NCT04708223
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 Fédération dentaire internationale (FDI) criteria on a scale from 1 "very good" to 5 "unacceptable"
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
Baseline
Results posted on
2025-10-23
Participant Flow
Unit of analysis: Teeth
Participant milestones
| Measure |
Fast-curing composites
Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
|
Conventionally applied composites
Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.
|
|---|---|---|
|
Overall Study
STARTED
|
51 50
|
51 50
|
|
Overall Study
6 Month
|
49 48
|
49 48
|
|
Overall Study
12 Month
|
40 36
|
40 39
|
|
Overall Study
24 Month
|
37 36
|
37 37
|
|
Overall Study
COMPLETED
|
31 30
|
31 29
|
|
Overall Study
NOT COMPLETED
|
20 20
|
20 21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Fast-curing composites
n=50 Teeth
Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
|
Conventionally applied composites
n=50 Teeth
Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.
|
Total
n=100 Teeth
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<= 18 years
|
0 participants
n=51 Participants
|
0 participants
n=51 Participants
|
0 participants
n=51 Participants
|
|
Age, Customized
18 to 80 years
|
51 participants
n=51 Participants
|
51 participants
n=51 Participants
|
51 participants
n=51 Participants
|
|
Sex/Gender, Customized
Female
|
34 participants
n=51 Participants
|
34 participants
n=51 Participants
|
34 participants
n=51 Participants
|
|
Sex/Gender, Customized
Male
|
17 participants
n=51 Participants
|
17 participants
n=51 Participants
|
17 participants
n=51 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
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 Fédération dentaire internationale (FDI) criteria on a scale from 1 "very good" to 5 "unacceptable"
Outcome measures
| Measure |
Fast-curing composites
n=51 Participants
Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
|
Conventionally applied composites
n=50 Teeth
Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.
|
|---|---|---|
|
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
FDI 11 - Postoperative Hypersensitivity: FDI Score 1
|
47 Teeth
|
45 Teeth
|
|
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
FDI 11 - Postoperative Hypersensitivity: FDI Score 2
|
3 Teeth
|
5 Teeth
|
|
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
FDI 11 - Postoperative Hypersensitivity: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
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 |
Fast-curing composites
n=48 Teeth
Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
|
Conventionally applied composites
n=48 Teeth
Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.
|
|---|---|---|
|
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
FDI 11 - Postoperative Hypersensitivity: FDI Score 1
|
46 Teeth
|
47 Teeth
|
|
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
FDI 11 - Postoperative Hypersensitivity: FDI Score 2
|
1 Teeth
|
1 Teeth
|
|
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
FDI 11 - Postoperative Hypersensitivity: FDI Score 3
|
1 Teeth
|
0 Teeth
|
|
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
FDI 11 - Postoperative Hypersensitivity: FDI Score 4-5
|
0 Teeth
|
0 Teeth
|
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 |
Fast-curing composites
n=39 Teeth
Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
|
Conventionally applied composites
n=36 Teeth
Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.
|
|---|---|---|
|
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
FDI 11 - Postoperative Hypersensitivity: FDI Score 1
|
38 Teeth
|
36 Teeth
|
|
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
FDI 11 - Postoperative Hypersensitivity: FDI Score 2
|
1 Teeth
|
0 Teeth
|
|
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
FDI 11 - Postoperative Hypersensitivity: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
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 |
Fast-curing composites
n=37 Teeth
Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
|
Conventionally applied composites
n=36 Teeth
Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.
|
|---|---|---|
|
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
FDI 11 - Postoperative Hypersensitivity: FDI Score 1
|
36 Teeth
|
36 Teeth
|
|
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
FDI 11 - Postoperative Hypersensitivity: FDI Score 2
|
1 Teeth
|
0 Teeth
|
|
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
FDI 11 - Postoperative Hypersensitivity: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
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 |
Fast-curing composites
n=31 Participants
Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
|
Conventionally applied composites
n=29 Teeth
Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.
|
|---|---|---|
|
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
FDI 11 - Postoperative Hypersensitivity: FDI Score 1
|
30 Teeth
|
28 Teeth
|
|
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
FDI 11 - Postoperative Hypersensitivity: FDI Score 2
|
0 Teeth
|
0 Teeth
|
|
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
FDI 11 - Postoperative Hypersensitivity: FDI Score 3
|
0 Teeth
|
1 Teeth
|
|
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
FDI 11 - Postoperative Hypersensitivity: FDI Score 4-5
|
0 Teeth
|
0 Teeth
|
SECONDARY outcome
Timeframe: Baselineassessed following the FDI criteria (patient view, tooth vitality, surface luster, surface staining, colour match, material fracture, marginal adaption, occlusal wear and tooth integrity) on a scale from 1 "very good" to 5 "unacceptable"
Outcome measures
| Measure |
Fast-curing composites
n=50 Teeth
Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
|
Conventionally applied composites
n=50 Teeth
Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.
|
|---|---|---|
|
Restoration Quality Evaluation
FDI 1 - Surface luster: FDI Score 1
|
44 Teeth
|
41 Teeth
|
|
Restoration Quality Evaluation
FDI 1 - Surface luster: FDI Score 2
|
6 Teeth
|
9 Teeth
|
|
Restoration Quality Evaluation
FDI 1 - Surface luster: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 2 - Surface staining: FDI Score 1
|
50 Teeth
|
47 Teeth
|
|
Restoration Quality Evaluation
FDI 2 - Surface staining: FDI Score 2
|
0 Teeth
|
3 Teeth
|
|
Restoration Quality Evaluation
FDI 2 - Surface staining: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 3 - Color match: FDI Score 1
|
28 Teeth
|
24 Teeth
|
|
Restoration Quality Evaluation
FDI 3 - Color match: FDI Score 2
|
20 Teeth
|
19 Teeth
|
|
Restoration Quality Evaluation
FDI 3 - Color match: FDI Score 3
|
2 Teeth
|
7 Teeth
|
|
Restoration Quality Evaluation
FDI 3 - Color match: FDI Score 4-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 5 - Material fracture: FDI Score 1
|
50 Teeth
|
49 Teeth
|
|
Restoration Quality Evaluation
FDI 5 - Material fracture: FDI Score 2
|
0 Teeth
|
1 Teeth
|
|
Restoration Quality Evaluation
FDI 5 - Material fracture: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 6 - Marginal adaption: FDI Score 1
|
49 Teeth
|
49 Teeth
|
|
Restoration Quality Evaluation
FDI 6 - Marginal adaption: FDI Score 2
|
1 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 6 - Marginal adaption: FDI Score 3
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 6 - Marginal adaption: FDI Score 4
|
0 Teeth
|
1 Teeth
|
|
Restoration Quality Evaluation
FDI 6 - Marginal adaption: FDI Score 5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 7 - Occlusal wear: FDI Score 1
|
50 Teeth
|
50 Teeth
|
|
Restoration Quality Evaluation
FDI 7 - Occlusal wear: FDI Score 2-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 10 - Patient's view: FDI Score 1
|
39 Teeth
|
42 Teeth
|
|
Restoration Quality Evaluation
FDI 10 - Patient's view: FDI Score 2
|
8 Teeth
|
4 Teeth
|
|
Restoration Quality Evaluation
FDI 10 - Patient's view: FDI Score 3
|
3 Teeth
|
2 Teeth
|
|
Restoration Quality Evaluation
FDI 10 - Patient's view: FDI Score 4
|
0 Teeth
|
2 Teeth
|
|
Restoration Quality Evaluation
FDI 10 - Patient's view: FDI Score 5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 11 - Tooth vitality: FDI Score 1
|
50 Teeth
|
50 Teeth
|
|
Restoration Quality Evaluation
FDI 11 - Tooth vitality: FDI Score 2-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 13 - Tooth integrity: FDI Score 1
|
50 Teeth
|
48 Teeth
|
|
Restoration Quality Evaluation
FDI 13 - Tooth integrity: FDI Score 2
|
0 Teeth
|
2 Teeth
|
|
Restoration Quality Evaluation
FDI 13 - Tooth integrity: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
SECONDARY outcome
Timeframe: 6 Monthassessed following the FDI criteria (patient view, tooth vitality, surface luster, surface staining, colour match, material fracture, marginal adaption, occlusal wear and tooth integrity) on a scale from 1 "very good" to 5 "unacceptable"
Outcome measures
| Measure |
Fast-curing composites
n=48 Teeth
Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
|
Conventionally applied composites
n=48 Teeth
Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.
|
|---|---|---|
|
Restoration Quality Evaluation
FDI 1 - Surface luster: FDI Score 1
|
41 Teeth
|
42 Teeth
|
|
Restoration Quality Evaluation
FDI 1 - Surface luster: FDI Score 2
|
7 Teeth
|
6 Teeth
|
|
Restoration Quality Evaluation
FDI 1 - Surface luster: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 2 - Surface staining: FDI Score 1
|
48 Teeth
|
46 Teeth
|
|
Restoration Quality Evaluation
FDI 2 - Surface staining: FDI Score 2
|
0 Teeth
|
2 Teeth
|
|
Restoration Quality Evaluation
FDI 2 - Surface staining: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 3 - Color match: FDI Score 1
|
29 Teeth
|
26 Teeth
|
|
Restoration Quality Evaluation
FDI 3 - Color match: FDI Score 2
|
16 Teeth
|
14 Teeth
|
|
Restoration Quality Evaluation
FDI 3 - Color match: FDI Score 3
|
3 Teeth
|
8 Teeth
|
|
Restoration Quality Evaluation
FDI 3 - Color match: FDI Score 4-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 5 - Material fracture: FDI Score 1
|
48 Teeth
|
47 Teeth
|
|
Restoration Quality Evaluation
FDI 5 - Material fracture: FDI Score 2
|
0 Teeth
|
1 Teeth
|
|
Restoration Quality Evaluation
FDI 5 - Material fracture: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 6 - Marginal adaption: FDI Score 1
|
47 Teeth
|
46 Teeth
|
|
Restoration Quality Evaluation
FDI 6 - Marginal adaption: FDI Score 2
|
1 Teeth
|
2 Teeth
|
|
Restoration Quality Evaluation
FDI 6 - Marginal adaption: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 7 - Occlusal wear: FDI Score 1
|
48 Teeth
|
48 Teeth
|
|
Restoration Quality Evaluation
FDI 7 - Occlusal wear: FDI Score 2-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 10 - Patient's view: FDI Score 1
|
37 Teeth
|
39 Teeth
|
|
Restoration Quality Evaluation
FDI 10 - Patient's view: FDI Score 2
|
8 Teeth
|
9 Teeth
|
|
Restoration Quality Evaluation
FDI 10 - Patient's view: FDI Score 3
|
3 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 10 - Patient's view: FDI Score 4-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 11 - Tooth vitality: FDI Score 1
|
48 Teeth
|
48 Teeth
|
|
Restoration Quality Evaluation
FDI 11 - Tooth vitality: FDI Score 2-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 13 - Tooth integrity: FDI Score 1
|
48 Teeth
|
47 Teeth
|
|
Restoration Quality Evaluation
FDI 13 - Tooth integrity: FDI Score 2
|
0 Teeth
|
1 Teeth
|
|
Restoration Quality Evaluation
FDI 13 - Tooth integrity: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
SECONDARY outcome
Timeframe: 12 Monthassessed following the FDI criteria (patient view, tooth vitality, surface luster, surface staining, colour match, material fracture, marginal adaption, occlusal wear and tooth integrity) on a scale from 1 "very good" to 5 "unacceptable"
Outcome measures
| Measure |
Fast-curing composites
n=39 Teeth
Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
|
Conventionally applied composites
n=36 Teeth
Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.
|
|---|---|---|
|
Restoration Quality Evaluation
FDI 6 - Marginal adaption: FDI Score 5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 7 - Occlusal wear: FDI Score 1
|
39 Teeth
|
36 Teeth
|
|
Restoration Quality Evaluation
FDI 7 - Occlusal wear: FDI Score 2-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 10 - Patient's view: FDI Score 1
|
33 Teeth
|
30 Teeth
|
|
Restoration Quality Evaluation
FDI 10 - Patient's view: FDI Score 2
|
4 Teeth
|
5 Teeth
|
|
Restoration Quality Evaluation
FDI 10 - Patient's view: FDI Score 3
|
2 Teeth
|
1 Teeth
|
|
Restoration Quality Evaluation
FDI 10 - Patient's view: FDI Score 4-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 11 - Tooth vitality: FDI Score 1
|
39 Teeth
|
36 Teeth
|
|
Restoration Quality Evaluation
FDI 11 - Tooth vitality: FDI Score 2-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 13 - Tooth integrity: FDI Score 1
|
36 Teeth
|
34 Teeth
|
|
Restoration Quality Evaluation
FDI 13 - Tooth integrity: FDI Score 2
|
2 Teeth
|
2 Teeth
|
|
Restoration Quality Evaluation
FDI 13 - Tooth integrity: FDI Score 3
|
1 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 13 - Tooth integrity: FDI Score 4-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 1 - Surface luster: FDI Score 1
|
35 Teeth
|
32 Teeth
|
|
Restoration Quality Evaluation
FDI 1 - Surface luster: FDI Score 2
|
4 Teeth
|
4 Teeth
|
|
Restoration Quality Evaluation
FDI 1 - Surface luster: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 2 - Surface staining: FDI Score 1
|
36 Teeth
|
29 Teeth
|
|
Restoration Quality Evaluation
FDI 2 - Surface staining: FDI Score 2
|
2 Teeth
|
5 Teeth
|
|
Restoration Quality Evaluation
FDI 2 - Surface staining: FDI Score 3
|
1 Teeth
|
2 Teeth
|
|
Restoration Quality Evaluation
FDI 2 - Surface staining: FDI Score 4-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 3 - Color match: FDI Score 1
|
17 Teeth
|
17 Teeth
|
|
Restoration Quality Evaluation
FDI 3 - Color match: FDI Score 2
|
18 Teeth
|
18 Teeth
|
|
Restoration Quality Evaluation
FDI 3 - Color match: FDI Score 3
|
4 Teeth
|
1 Teeth
|
|
Restoration Quality Evaluation
FDI 3 - Color match: FDI Score 4-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 5 - Material fracture: FDI Score 1
|
38 Teeth
|
36 Teeth
|
|
Restoration Quality Evaluation
FDI 5 - Material fracture: FDI Score 2
|
1 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 5 - Material fracture: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 6 - Marginal adaption: FDI Score 1
|
36 Teeth
|
33 Teeth
|
|
Restoration Quality Evaluation
FDI 6 - Marginal adaption: FDI Score 2
|
3 Teeth
|
2 Teeth
|
|
Restoration Quality Evaluation
FDI 6 - Marginal adaption: FDI Score 3
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 6 - Marginal adaption: FDI Score 4
|
0 Teeth
|
1 Teeth
|
SECONDARY outcome
Timeframe: 24 Monthassessed following the FDI criteria (patient view, tooth vitality, surface luster, surface staining, colour match, material fracture, marginal adaption, occlusal wear and tooth integrity) on a scale from 1 "very good" to 5 "unacceptable"
Outcome measures
| Measure |
Fast-curing composites
n=37 Teeth
Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
|
Conventionally applied composites
n=36 Teeth
Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.
|
|---|---|---|
|
Restoration Quality Evaluation
FDI 1 - Surface luster: FDI Score 1
|
26 Teeth
|
25 Teeth
|
|
Restoration Quality Evaluation
FDI 1 - Surface luster: FDI Score 2
|
11 Teeth
|
11 Teeth
|
|
Restoration Quality Evaluation
FDI 1 - Surface luster: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 2 - Surface staining: FDI Score 1
|
31 Teeth
|
28 Teeth
|
|
Restoration Quality Evaluation
FDI 2 - Surface staining: FDI Score 2
|
4 Teeth
|
7 Teeth
|
|
Restoration Quality Evaluation
FDI 2 - Surface staining: FDI Score 3
|
2 Teeth
|
1 Teeth
|
|
Restoration Quality Evaluation
FDI 2 - Surface staining: FDI Score 4-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 3 - Color match: FDI Score 1
|
17 Teeth
|
18 Teeth
|
|
Restoration Quality Evaluation
FDI 3 - Color match: FDI Score 2
|
14 Teeth
|
12 Teeth
|
|
Restoration Quality Evaluation
FDI 3 - Color match: FDI Score 3
|
6 Teeth
|
6 Teeth
|
|
Restoration Quality Evaluation
FDI 3 - Color match: FDI Score 4-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 5 - Material fracture: FDI Score 1
|
36 Teeth
|
36 Teeth
|
|
Restoration Quality Evaluation
FDI 5 - Material fracture: FDI Score 2
|
1 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 5 - Material fracture: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 6 - Marginal adaption: FDI Score 1
|
34 Teeth
|
35 Teeth
|
|
Restoration Quality Evaluation
FDI 6 - Marginal adaption: FDI Score 2
|
3 Teeth
|
1 Teeth
|
|
Restoration Quality Evaluation
FDI 6 - Marginal adaption: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 7 - Occlusal wear: FDI Score 1
|
35 Teeth
|
35 Teeth
|
|
Restoration Quality Evaluation
FDI 7 - Occlusal wear: FDI Score 2
|
2 Teeth
|
1 Teeth
|
|
Restoration Quality Evaluation
FDI 7 - Occlusal wear: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 10 - Patient's view: FDI Score 1
|
29 Teeth
|
30 Teeth
|
|
Restoration Quality Evaluation
FDI 10 - Patient's view: FDI Score 2
|
6 Teeth
|
4 Teeth
|
|
Restoration Quality Evaluation
FDI 10 - Patient's view: FDI Score 3
|
2 Teeth
|
2 Teeth
|
|
Restoration Quality Evaluation
FDI 10 - Patient's view: FDI Score 4-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 11 - Tooth vitality: FDI Score 1
|
37 Teeth
|
36 Teeth
|
|
Restoration Quality Evaluation
FDI 11 - Tooth vitality: FDI Score 2-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 13 - Tooth integrity: FDI Score 1
|
36 Teeth
|
36 Teeth
|
|
Restoration Quality Evaluation
FDI 13 - Tooth integrity: FDI Score 2
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 13 - Tooth integrity: FDI Score 3
|
1 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 13 - Tooth integrity: FDI Score 4-5
|
0 Teeth
|
0 Teeth
|
SECONDARY outcome
Timeframe: 36 Monthassessed following the FDI criteria (patient view, tooth vitality, surface luster, surface staining, colour match, material fracture, marginal adaption, occlusal wear and tooth integrity) on a scale from 1 "very good" to 5 "unacceptable"
Outcome measures
| Measure |
Fast-curing composites
n=30 Teeth
Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
|
Conventionally applied composites
n=29 Teeth
Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.
|
|---|---|---|
|
Restoration Quality Evaluation
FDI 13 - Tooth integrity: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 1 - Surface luster: FDI Score 1
|
20 Teeth
|
20 Teeth
|
|
Restoration Quality Evaluation
FDI 1 - Surface luster: FDI Score 2
|
10 Teeth
|
9 Teeth
|
|
Restoration Quality Evaluation
FDI 1 - Surface luster: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 2 - Surface staining: FDI Score 1
|
26 Teeth
|
20 Teeth
|
|
Restoration Quality Evaluation
FDI 2 - Surface staining: FDI Score 2
|
4 Teeth
|
9 Teeth
|
|
Restoration Quality Evaluation
FDI 2 - Surface staining: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 3 - Color match: FDI Score 1
|
15 Teeth
|
13 Teeth
|
|
Restoration Quality Evaluation
FDI 3 - Color match: FDI Score 2
|
8 Teeth
|
10 Teeth
|
|
Restoration Quality Evaluation
FDI 3 - Color match: FDI Score 3
|
7 Teeth
|
6 Teeth
|
|
Restoration Quality Evaluation
FDI 3 - Color match: FDI Score 4-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 5 - Material fracture: FDI Score 1
|
30 Teeth
|
29 Teeth
|
|
Restoration Quality Evaluation
FDI 5 - Material fracture: FDI Score 2-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 6 - Marginal adaption: FDI Score 1
|
28 Teeth
|
25 Teeth
|
|
Restoration Quality Evaluation
FDI 6 - Marginal adaption: FDI Score 2
|
2 Teeth
|
4 Teeth
|
|
Restoration Quality Evaluation
FDI 6 - Marginal adaption: FDI Score 3-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 7 - Occlusal wear: FDI Score 1
|
30 Teeth
|
29 Teeth
|
|
Restoration Quality Evaluation
FDI 7 - Occlusal wear: FDI Score 2-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 10 - Patient's view: FDI Score 1
|
26 Teeth
|
25 Teeth
|
|
Restoration Quality Evaluation
FDI 10 - Patient's view: FDI Score 2
|
3 Teeth
|
3 Teeth
|
|
Restoration Quality Evaluation
FDI 10 - Patient's view: FDI Score 3
|
1 Teeth
|
1 Teeth
|
|
Restoration Quality Evaluation
FDI 10 - Patient's view: FDI Score 4-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 11 - Tooth vitality: FDI Score 1
|
30 Teeth
|
29 Teeth
|
|
Restoration Quality Evaluation
FDI 11 - Tooth vitality: FDI Score 2-5
|
0 Teeth
|
0 Teeth
|
|
Restoration Quality Evaluation
FDI 13 - Tooth integrity: FDI Score 1
|
27 Teeth
|
24 Teeth
|
|
Restoration Quality Evaluation
FDI 13 - Tooth integrity: FDI Score 2
|
0 Teeth
|
2 Teeth
|
|
Restoration Quality Evaluation
DI 13 - Tooth integrity: n/a
|
3 Teeth
|
3 Teeth
|
Adverse Events
Fast-curing composites
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Conventionally applied composites
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fast-curing composites
n=51 participants at risk
Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
|
Conventionally applied composites
n=51 participants at risk
Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill): Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.
|
|---|---|---|
|
General disorders
Unrelated: Lesion next to study tooth
|
2.0%
1/51 • 36 Month
|
0.00%
0/51 • 36 Month
|
|
General disorders
Buccal side repair
|
0.00%
0/51 • 36 Month
|
2.0%
1/51 • 36 Month
|
|
General disorders
Unlikely related: Sensitivity near study tooth
|
2.0%
1/51 • 36 Month
|
0.00%
0/51 • 36 Month
|
|
General disorders
Sensitivity
|
5.9%
3/51 • 36 Month
|
3.9%
2/51 • 36 Month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60