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The purpose of this study is to compare the clinical performance of a new resin based filling material to an established resin-based filling material in posterior teeth at 2 different study centers.
The objective of this study is to compare the performance of the composite resin Venus Pearl and a commercially available control composite material for the restoration of class II-cavities. Primary endpoints of the study are a mean score for each patient calculated from aesthetic, functional attribute and biological parameters. Secondary endpoints are the evaluation of secondary caries, plaque accumulation and gingival reactions and the comparison of the primary score at week 1, month 6, month 12 and month 24 after restoration. Beside this, the single components of the three categories of the primary endpoints will be compared. The study will be executed as a multi-center (Oregon Health & Science University, Portland, OR, USA and Medical School Hannover, Hannover, Germany), single-blinded and randomized clinical investigation. 90 comparable cavities per study site will be treated (45 cavities for each material at each site).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venus Pearl | Experimental | Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration. |
|
| control resin-based filling material | Active Comparator | Placement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placement of restoration | Device | Placement of restorations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Score for Surface Luster | 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 | 2 years |
| Score for Surface Staining | 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 staining | 2 years |
| Score for Marginal Discoloration | 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 marginal discoloration | 2 years |
| Score for Fracture and Retention | 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 functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for fracture and retention | 2 years |
| Score for Color Match | 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 color match |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Werner Geurtsen, Prof. Dr. | Hannover Medical School | Study Chair |
| Gabriela Ibarra, DDS, MPH, MS | Oregon Health and Science University | Principal Investigator |
| Werner Geurtsen, Prof. Dr. | Medical School Hannover | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University-School of Dentistry | Portland | Oregon | 97239 | United States | ||
| Medical School Hannover |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
90 restorations with each material were placed at T0 (in total 180). 7 days afterwards baseline analysis was performed and not all patients from T0 showed up at baseline. That is why the participant and restoration number between T0 and baseline differs.
Each patient was eligible to receive up to 4 restorations, with either test or control material. That means the same patient can have received restoration(s)with VP as well as with control.116 is the absolute patient number at baseline.
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Control Resin-based Filling Material |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Score for Surface Luster | 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 | Posted | Mean | Standard Deviation | scores on a scale | 2 years | Restorations | Restorations |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Venus Pearl | Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Scientific Affairs Management | Kulzer GmbH | +4915116891006 | andrea.leyer@kulzer-dental.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2013 | May 24, 2024 | Prot_SAP_000.pdf |
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| 2 years |
| Score for Esthetic Anatomical Form | 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 esthetic anatomical form | 2 years |
| Score for Marginal Adaptation | 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 functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for marginal adaptation | 2 years |
| Score for Abrasion | 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 functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for abrasion | 2 years |
| Score for Approximal Anatomical Form | 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 functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for approximal anatomical form | 2 years |
| Score for Satisfaction of Patient | 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 functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for satisfaction of patient | 2 years |
| Score for Post-operative Hypersensitivity | 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 biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for post-operative hypersensitivity | 2 years |
| Score for Caries, Erosion | 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 biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for caries, erosion | 2 years |
| Score for "Tooth Integrity" | 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 biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for "tooth integrity" | 2 years |
| Score for Parodontal Reaction | 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 biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for parodontal reaction | 2 years |
| Score for Adjacent Mucosa | 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 biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for adjacent mucosa | 2 years |
| Hanover |
| 30625 |
| Germany |
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
| BG002 | Total | Total of all reporting groups |
| Restorations |
|
| Number |
| years |
| Restorations |
|
|
| Sex: Female, Male | 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). | Count of Units | Restorations | Restorations |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Post-operative hypersensitivity |
| 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). | Mean | Standard Deviation | scores on a scale | Restorations |
|
|
| Caries, erosion |
| 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). | Mean | Standard Deviation | scores on a scale | Restorations |
|
|
| "Tooth integrity" |
| 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). | Mean | Standard Deviation | scores on a scale | Restorations |
|
|
| Parodontal reaction |
| 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). | Mean | Standard Deviation | scores on a scale | Restorations |
|
|
| Adjacent mucosa |
| 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). | Mean | Standard Deviation | scores on a scale | Restorations |
|
|
| Fracture and retention |
| 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). | Mean | Standard Deviation | scores on a scale | Restorations |
|
|
| Marginal adaptation |
| 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). | Mean | Standard Deviation | scores on a scale | Restorations |
|
|
| Abrasion |
| 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). | Mean | Standard Deviation | scores on a scale | Restorations |
|
|
| Approximal anatomical form |
| 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). | Mean | Standard Deviation | scores on a scale | Restorations |
|
|
| Surface luster |
| 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). | Mean | Standard Deviation | scores on a scale | Restorations |
|
|
| Satisfaction of patient |
| 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). | Mean | Standard Deviation | scores on a scale | Restorations |
|
|
| Marginal discoloration |
| 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). | Mean | Standard Deviation | scores on a scale | Restorations |
|
|
| Surface staining |
| 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). | Mean | Standard Deviation | scores on a scale | Restorations |
|
|
| Color match |
| 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). | Mean | Standard Deviation | scores on a scale | Restorations |
|
|
| Esthetic anatomical form |
| 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). | Mean | Standard Deviation | scores on a scale | 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
|
|
| Primary | Score for Surface Staining | 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 staining | Posted | Mean | Standard Deviation | scores on a scale | 2 years | Restorations | Restorations |
|
|
|
| Primary | Score for Marginal Discoloration | 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 marginal discoloration | Posted | Mean | Standard Deviation | scores on a scale | 2 years | Restorations | Restorations |
|
|
|
| Primary | Score for Fracture and Retention | 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 functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for fracture and retention | Posted | Mean | Standard Deviation | scores on a scale | 2 years | Restorations | Restorations |
|
|
|
| Primary | Score for Color Match | 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 color match | Posted | Mean | Standard Deviation | scores on a scale | 2 years | Restorations | Restorations |
|
|
|
| Primary | Score for Esthetic Anatomical Form | 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 esthetic anatomical form | Posted | Mean | Standard Deviation | scores on a scale | 2 years | Restorations | Restorations |
|
|
|
| Primary | Score for Marginal Adaptation | 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 functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for marginal adaptation | Posted | Mean | Standard Deviation | scores on a scale | 2 years | Restorations | Restorations |
|
|
|
| Primary | Score for Abrasion | 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 functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for abrasion | Posted | Mean | Standard Deviation | scores on a scale | 2 years | Restorations | Restorations |
|
|
|
| Primary | Score for Approximal Anatomical Form | 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 functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for approximal anatomical form | Posted | Mean | Standard Deviation | scores on a scale | 2 years | Restorations | Restorations |
|
|
|
| Primary | Score for Satisfaction of Patient | 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 functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for satisfaction of patient | Posted | Mean | Standard Deviation | scores on a scale | 2 years | Restorations | Restorations |
|
|
|
| Primary | Score for Post-operative Hypersensitivity | 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 biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for post-operative hypersensitivity | Posted | Mean | Standard Deviation | scores on a scale | 2 years | Restorations | Restorations |
|
|
|
| Primary | Score for Caries, Erosion | 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 biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for caries, erosion | Posted | Mean | Standard Deviation | scores on a scale | 2 years | Restorations | Restorations |
|
|
|
| Primary | Score for "Tooth Integrity" | 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 biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for "tooth integrity" | Posted | Mean | Standard Deviation | scores on a scale | 2 years | Restorations | Restorations |
|
|
|
| Primary | Score for Parodontal Reaction | 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 biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for parodontal reaction | Posted | Mean | Standard Deviation | scores on a scale | 2 years | Restorations | Restorations |
|
|
|
| Primary | Score for Adjacent Mucosa | 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 biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for adjacent mucosa | Posted | Mean | Standard Deviation | scores on a scale | 2 years | Restorations | Restorations |
|
|
|
| 0 |
| 90 |
| 0 |
| 90 |
| 0 |
| 90 |
| EG001 | 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. | 0 | 90 | 0 | 90 | 0 | 90 |
Not provided