Trial Outcomes & Findings for Optical Properties of Light Cured Luting Agent on Laminate Veneer (NCT NCT02464540)
NCT ID: NCT02464540
Last Updated: 2020-02-17
Results Overview
The color of laminate veneers will be performed with a spectrophotometer Vita Easyshade (Vita Zahnfabrik / Bad Saeckingen, Germany) based on Vita and 3D Master scales and on CIEL\*a\* b system. Data collected will be evaluated for translucency parameter (TP) and color difference (ΔE) according the thickness and color of the laminate veneers as well as color of dental substrate. The acceptable threshold color difference for the CIEDE2000 method is 1.8 (Paravina et al, 2015). Greater color variation is desirable when a shade match between darker and lighter adjacent tooth substrates is required and values above the clinical thresholds for acceptability of color differences indicating lower masking ability of the material. "Level of Agreement Between the Color Observed by the Operator and the Color Named by the Spectrophotometer" was included as a Primary or Secondary Outcome Measure, but data was not collected.
COMPLETED
NA
11 participants
after luting the laminate veneers (at least 1 hours after cementation)
2020-02-17
Participant Flow
Unit of analysis: ceramic restoration
Participant milestones
| Measure |
Light-cured Resin Cement
Ceramic restorations were cemented using translucent shade of photoactivated resin cement (RelyX Veneer; 3M ESPE).
|
Light-cured Flowable Composite
Ceramic restorations were cemented using translucent shade of flowable composite (Tetric N-Flow; Ivoclar Vivadent AG)
|
|---|---|---|
|
Overall Study
STARTED
|
11 17
|
11 21
|
|
Overall Study
COMPLETED
|
11 17
|
11 21
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optical Properties of Light Cured Luting Agent on Laminate Veneer
Baseline characteristics by cohort
| Measure |
Light-cured Resin Cement - Light-cured Flowable Composite
n=38 ceramic restoration
Ceramic restorations were cemented using translucent shade of photoactivated resin cement or Light-cured flowable composite. Participants enrolled in both arms, luting material to be used was randomly selected.
|
|---|---|
|
Age, Continuous
Age
|
39.6 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after luting the laminate veneers (at least 1 hours after cementation)Population: 38 ceramic restorations were cemented (25 laminate veneers, 13 crowns; 37 in anterior teeth; 1 in posterior tooth).
The color of laminate veneers will be performed with a spectrophotometer Vita Easyshade (Vita Zahnfabrik / Bad Saeckingen, Germany) based on Vita and 3D Master scales and on CIEL\*a\* b system. Data collected will be evaluated for translucency parameter (TP) and color difference (ΔE) according the thickness and color of the laminate veneers as well as color of dental substrate. The acceptable threshold color difference for the CIEDE2000 method is 1.8 (Paravina et al, 2015). Greater color variation is desirable when a shade match between darker and lighter adjacent tooth substrates is required and values above the clinical thresholds for acceptability of color differences indicating lower masking ability of the material. "Level of Agreement Between the Color Observed by the Operator and the Color Named by the Spectrophotometer" was included as a Primary or Secondary Outcome Measure, but data was not collected.
Outcome measures
| Measure |
Light-cured Resin Cement
n=17 ceramic restoration
Color change was estimated by calculating the CIEDE2000 formula. Corresponding ΔE00 values for perceptibility and acceptability were 0.8 and 1.8, respectively. (Paravina, 2015)
|
Light-cured Flowable Composite
n=21 ceramic restoration
Color change was estimated by calculating the CIEDE2000 formula. Corresponding ΔE00 values for perceptibility and acceptability were 0.8 and 1.8, respectively. (Paravina, 2015)
|
|---|---|---|
|
Optical Properties of Laminate Veneers
|
5.31 Delta E (color change)
Standard Deviation 1.80
|
5.07 Delta E (color change)
Standard Deviation 2.37
|
Adverse Events
Light-cured Resin Cement
Light-cured Flowable Composite
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place