Trial Outcomes & Findings for Comparison of 2 Different Resin Based Filling Materials in Posterior Teeth - a Multicenter Study (NCT NCT01925040)
NCT ID: NCT01925040
Last Updated: 2024-10-28
Results Overview
The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of esthetic properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for surface luster
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
130 participants
Primary outcome timeframe
2 years
Results posted on
2024-10-28
Participant Flow
The total number of patients that started the study was 130. However, each patient was eligible to receive up to four restorations, with either a test or a control material. That means the same patient can have received a restoration/restorations with Venus Pearl as well as with the control resin-based filling material. That is the reason why the sum of the following participants differs from the total patient number 130. The analysis was restoration based.
Unit of analysis: restorations
Participant milestones
| Measure |
Venus Pearl
Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
Control Resin-based Filling Material
Placement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
|---|---|---|
|
Overall Study
STARTED
|
85 90
|
83 90
|
|
Overall Study
COMPLETED
|
49 55
|
48 53
|
|
Overall Study
NOT COMPLETED
|
36 35
|
35 37
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
Baseline characteristics by cohort
| Measure |
Venus Pearl
n=83 Restorations
Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
Control Resin-based Filling Material
n=80 Restorations
Placement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
Total
n=163 Restorations
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 18 years
|
0 years
n=83 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
0 years
n=80 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
0 years
n=163 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
|
Age, Customized
18 - 75 years
|
83 years
n=83 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
80 years
n=80 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
163 years
n=163 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
|
Age, Customized
> 75 years
|
0 years
n=83 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
0 years
n=80 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
0 years
n=163 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
|
Sex: Female, Male
Female
|
43 Restorations
n=83 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
42 Restorations
n=80 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
85 Restorations
n=163 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
|
Sex: Female, Male
Male
|
40 Restorations
n=83 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
38 Restorations
n=80 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
78 Restorations
n=163 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Post-operative hypersensitivity
|
1.08 scores on a scale
STANDARD_DEVIATION 0.28 • n=83 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.06 scores on a scale
STANDARD_DEVIATION 0.24 • n=80 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.07 scores on a scale
STANDARD_DEVIATION 0.26 • n=163 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
|
Caries, erosion
|
1.05 scores on a scale
STANDARD_DEVIATION 0.22 • n=83 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.06 scores on a scale
STANDARD_DEVIATION 0.24 • n=80 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.06 scores on a scale
STANDARD_DEVIATION 0.25 • n=163 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
|
"Tooth integrity"
|
1.04 scores on a scale
STANDARD_DEVIATION 0.19 • n=83 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.06 scores on a scale
STANDARD_DEVIATION 0.24 • n=80 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.05 scores on a scale
STANDARD_DEVIATION 0.22 • n=163 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
|
Parodontal reaction
|
1.17 scores on a scale
STANDARD_DEVIATION 0.38 • n=83 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.2 scores on a scale
STANDARD_DEVIATION 0.51 • n=80 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.18 scores on a scale
STANDARD_DEVIATION 0.45 • n=163 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
|
Adjacent mucosa
|
1.12 scores on a scale
STANDARD_DEVIATION 0.36 • n=83 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.2 scores on a scale
STANDARD_DEVIATION 0.49 • n=80 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.16 scores on a scale
STANDARD_DEVIATION 0.43 • n=163 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
|
Fracture and retention
|
1.10 scores on a scale
STANDARD_DEVIATION 0.46 • n=83 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.08 scores on a scale
STANDARD_DEVIATION 0.31 • n=80 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.09 scores on a scale
STANDARD_DEVIATION 0.39 • n=163 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
|
Marginal adaptation
|
1.25 scores on a scale
STANDARD_DEVIATION 0.58 • n=83 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.16 scores on a scale
STANDARD_DEVIATION 0.4 • n=80 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.21 scores on a scale
STANDARD_DEVIATION 0.5 • n=163 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
|
Abrasion
|
1.01 scores on a scale
STANDARD_DEVIATION 0.11 • n=83 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.03 scores on a scale
STANDARD_DEVIATION 0.22 • n=80 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.02 scores on a scale
STANDARD_DEVIATION 0.17 • n=163 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
|
Approximal anatomical form
|
1.38 scores on a scale
STANDARD_DEVIATION 0.7 • n=83 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.29 scores on a scale
STANDARD_DEVIATION 0.53 • n=80 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.33 scores on a scale
STANDARD_DEVIATION 0.62 • n=163 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
|
Surface luster
|
1.28 scores on a scale
STANDARD_DEVIATION 0.51 • n=83 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.28 scores on a scale
STANDARD_DEVIATION 0.45 • n=80 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.28 scores on a scale
STANDARD_DEVIATION 0.48 • n=163 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
|
Satisfaction of patient
|
1.11 scores on a scale
STANDARD_DEVIATION 0.44 • n=83 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.06 scores on a scale
STANDARD_DEVIATION 0.24 • n=80 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.09 scores on a scale
STANDARD_DEVIATION 0.36 • n=163 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
|
Marginal discoloration
|
1.16 scores on a scale
STANDARD_DEVIATION 0.4 • n=83 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.26 scores on a scale
STANDARD_DEVIATION 0.5 • n=80 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.18 scores on a scale
STANDARD_DEVIATION 0.43 • n=163 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
|
Surface staining
|
1.11 scores on a scale
STANDARD_DEVIATION 0.35 • n=83 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.1 scores on a scale
STANDARD_DEVIATION 0.3 • n=80 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.1 scores on a scale
STANDARD_DEVIATION 0.33 • n=163 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
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|
Color match
|
1.27 scores on a scale
STANDARD_DEVIATION 0.47 • n=83 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.26 scores on a scale
STANDARD_DEVIATION 0.5 • n=80 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.26 scores on a scale
STANDARD_DEVIATION 0.48 • n=163 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
|
Esthetic anatomical form
|
1.22 scores on a scale
STANDARD_DEVIATION 0.52 • n=83 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.24 scores on a scale
STANDARD_DEVIATION 0.48 • n=80 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
1.22 scores on a scale
STANDARD_DEVIATION 0.5 • n=163 Restorations • Each patient was eligible to receive up to 4 restorations, with either VP or control. So, e.g. the same patient can have received 1 restoration with VP and 1 restoration with control. So, materialwise there is 1 patient for VP and 1 patient for control, which adds up in the ClinicalTrial system in the total column as 2 patients, even though it was only 1 patient. This is why the patient numbers in the columns do not represent the sum of the absolute patient number (116).
|
PRIMARY outcome
Timeframe: 2 yearsThe primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of esthetic properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for surface luster
Outcome measures
| Measure |
Venus Pearl
n=55 Restorations
Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
Control Resin-based Filling Material
n=53 Restorations
Placement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
|---|---|---|
|
Score for Surface Luster
|
1.89 scores on a scale
Standard Deviation 0.6
|
1.62 scores on a scale
Standard Deviation 0.63
|
PRIMARY outcome
Timeframe: 2 yearsThe primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of esthetic properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for surface staining
Outcome measures
| Measure |
Venus Pearl
n=55 Restorations
Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
Control Resin-based Filling Material
n=53 Restorations
Placement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
|---|---|---|
|
Score for Surface Staining
|
1.44 scores on a scale
Standard Deviation 0.54
|
1.34 scores on a scale
Standard Deviation 0.52
|
PRIMARY outcome
Timeframe: 2 yearsThe primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of esthetic properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for marginal discoloration
Outcome measures
| Measure |
Venus Pearl
n=55 Restorations
Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
Control Resin-based Filling Material
n=53 Restorations
Placement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
|---|---|---|
|
Score for Marginal Discoloration
|
1.49 scores on a scale
Standard Deviation 0.57
|
1.47 scores on a scale
Standard Deviation 0.72
|
PRIMARY outcome
Timeframe: 2 yearsThe primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for fracture and retention
Outcome measures
| Measure |
Venus Pearl
n=55 Restorations
Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
Control Resin-based Filling Material
n=53 Restorations
Placement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
|---|---|---|
|
Score for Fracture and Retention
|
1.24 scores on a scale
Standard Deviation 0.58
|
1.32 scores on a scale
Standard Deviation 0.64
|
PRIMARY outcome
Timeframe: 2 yearsThe primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of esthetic properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for color match
Outcome measures
| Measure |
Venus Pearl
n=55 Restorations
Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
Control Resin-based Filling Material
n=53 Restorations
Placement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
|---|---|---|
|
Score for Color Match
|
1.64 scores on a scale
Standard Deviation 0.7
|
1.64 scores on a scale
Standard Deviation 0.68
|
PRIMARY outcome
Timeframe: 2 yearsThe primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of esthetic properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for esthetic anatomical form
Outcome measures
| Measure |
Venus Pearl
n=55 Restorations
Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
Control Resin-based Filling Material
n=53 Restorations
Placement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
|---|---|---|
|
Score for Esthetic Anatomical Form
|
1.49 scores on a scale
Standard Deviation 0.63
|
1.45 scores on a scale
Standard Deviation 0.64
|
PRIMARY outcome
Timeframe: 2 yearsThe primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for marginal adaptation
Outcome measures
| Measure |
Venus Pearl
n=55 Restorations
Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
Control Resin-based Filling Material
n=53 Restorations
Placement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
|---|---|---|
|
Score for Marginal Adaptation
|
1.29 scores on a scale
Standard Deviation 0.53
|
1.42 scores on a scale
Standard Deviation 0.69
|
PRIMARY outcome
Timeframe: 2 yearsThe primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for abrasion
Outcome measures
| Measure |
Venus Pearl
n=55 Restorations
Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
Control Resin-based Filling Material
n=53 Restorations
Placement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
|---|---|---|
|
Score for Abrasion
|
1.16 scores on a scale
Standard Deviation 0.42
|
1.17 scores on a scale
Standard Deviation 0.43
|
PRIMARY outcome
Timeframe: 2 yearsThe primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for approximal anatomical form
Outcome measures
| Measure |
Venus Pearl
n=55 Restorations
Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
Control Resin-based Filling Material
n=53 Restorations
Placement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
|---|---|---|
|
Score for Approximal Anatomical Form
|
1.44 scores on a scale
Standard Deviation 0.76
|
1.23 scores on a scale
Standard Deviation 0.51
|
PRIMARY outcome
Timeframe: 2 yearsThe primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for satisfaction of patient
Outcome measures
| Measure |
Venus Pearl
n=55 Restorations
Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
Control Resin-based Filling Material
n=53 Restorations
Placement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
|---|---|---|
|
Score for Satisfaction of Patient
|
1.04 scores on a scale
Standard Deviation 0.27
|
1.06 scores on a scale
Standard Deviation 0.41
|
PRIMARY outcome
Timeframe: 2 yearsThe primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for post-operative hypersensitivity
Outcome measures
| Measure |
Venus Pearl
n=55 Restorations
Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
Control Resin-based Filling Material
n=53 Restorations
Placement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
|---|---|---|
|
Score for Post-operative Hypersensitivity
|
1.04 scores on a scale
Standard Deviation 0.19
|
1.04 scores on a scale
Standard Deviation 0.19
|
PRIMARY outcome
Timeframe: 2 yearsThe primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for caries, erosion
Outcome measures
| Measure |
Venus Pearl
n=55 Restorations
Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
Control Resin-based Filling Material
n=53 Restorations
Placement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
|---|---|---|
|
Score for Caries, Erosion
|
1.02 scores on a scale
Standard Deviation 0.13
|
1.08 scores on a scale
Standard Deviation 0.43
|
PRIMARY outcome
Timeframe: 2 yearsThe primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for "tooth integrity"
Outcome measures
| Measure |
Venus Pearl
n=55 Restorations
Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
Control Resin-based Filling Material
n=53 Restorations
Placement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
|---|---|---|
|
Score for "Tooth Integrity"
|
1.11 scores on a scale
Standard Deviation 0.37
|
1.19 scores on a scale
Standard Deviation 0.44
|
PRIMARY outcome
Timeframe: 2 yearsThe primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for parodontal reaction
Outcome measures
| Measure |
Venus Pearl
n=55 Restorations
Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
Control Resin-based Filling Material
n=53 Restorations
Placement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
|---|---|---|
|
Score for Parodontal Reaction
|
1.45 scores on a scale
Standard Deviation 0.77
|
1.36 scores on a scale
Standard Deviation 0.68
|
PRIMARY outcome
Timeframe: 2 yearsThe primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for adjacent mucosa
Outcome measures
| Measure |
Venus Pearl
n=55 Restorations
Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
Control Resin-based Filling Material
n=53 Restorations
Placement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration.
Placement of restoration: Placement of restorations
|
|---|---|---|
|
Score for Adjacent Mucosa
|
1.07 scores on a scale
Standard Deviation 0.26
|
1.11 scores on a scale
Standard Deviation 0.42
|
Adverse Events
Venus Pearl
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Resin-based Filling Material
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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
Restriction type: GT60