Caries, Unsatisfactory or Defective Restoration of Tooth
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DEVICEPlacement of restoration
Placement of restorations
Sponsors
Heraeus Kulzer GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients should be 18 years and older. * Study teeth should have an interproximal (Class II) carious lesion or an existing defective class II restoration requiring restorative therapy on premolars or molars. * The maximum cavity depth determined by the radiograph will be D2 (Tyas classification). * The teeth included in the study need to have a proximal contact with the adjacent tooth and be in occlusion with the opposing dentition. * The teeth included in the study should be vital with no signs of pulpal pathology. * Patients that report brushing regularly without severe gingival inflammation and/or extensive caries. * Patients should have no allergies or systemic diseases which inhibit the treatment. * Patients should have voluntary participation and sign a written informed consent form. * Patients should be willing to participate in the recall/re-examination appointments.
Exclusion criteria
* Simultaneous participation in another study about dental restorative materials. * Written informed consent form not signed. * Nonvital pulp / periapical lesion. * Insufficient oral hygiene despite detailed instructions. * Pregnancy/ breast feeding before placement of the study restoration. * Minors. * Severe malocclusion/ malalignment/ traumatic occlusion/ bruxism. * Known allergy to any components present in any of the materials that are used for this study. * Unclear mucosal alterations, e.g. oral lichenoid reactions/lesions. * Severe medical complications (organ transplants, cancer, immune-compromised, long-term antibiotic or steroid therapy). * Infectious diseases such as HIV/Aids, Hepatitis, etc. * Application of bleaching products less than 14 days before placement of the restoration. * Orthodontic treatment during the study. * Xerostomia. * Untreated periodontal diseases. * Rampant or extensive caries present. * Systemic diseases with potential oral manifestation. * Sufficient isolation according to the criteria of adhesive techniques not possible, e.g. application of rubber dam. * Direct adhesive restoration not indicated. * Replacement of more than one cusp indicated. * Dental fears patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score for Surface Luster | 2 years | 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 |
| Score for Surface Staining | 2 years | 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 |
| Score for Marginal Discoloration | 2 years | 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 |
| Score for Fracture and Retention | 2 years | 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 |
| Score for Color Match | 2 years | 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 |
| Score for Esthetic Anatomical Form | 2 years | 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 |
| Score for Marginal Adaptation | 2 years | 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 |
| Score for Abrasion | 2 years | 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 |
| Score for Approximal Anatomical Form | 2 years | 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 |
| Score for Satisfaction of Patient | 2 years | 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 |
| Score for Post-operative Hypersensitivity | 2 years | 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 |
| Score for Caries, Erosion | 2 years | 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 |
| Score for Tooth Integrity | 2 years | 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 |
| Score for Parodontal Reaction | 2 years | 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 |
| Score for Adjacent Mucosa | 2 years | 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 |
Countries
Germany, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 78 |
| 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 | 83 |
| 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 | 75 |
| 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 | 80 |
| Total | 316 |
Baseline characteristics
| Characteristic | Venus Pearl | Control Resin-based Filling Material | Total |
|---|---|---|---|
| Abrasion | 1.01 scores on a scale STANDARD_DEVIATION 0.11 | 1.03 scores on a scale STANDARD_DEVIATION 0.22 | 1.02 scores on a scale STANDARD_DEVIATION 0.17 |
| Adjacent mucosa | 1.12 scores on a scale STANDARD_DEVIATION 0.36 | 1.2 scores on a scale STANDARD_DEVIATION 0.49 | 1.16 scores on a scale STANDARD_DEVIATION 0.43 |
| Age, Customized 18 - 75 years | 83 years | 80 years | 163 years |
| Age, Customized < 18 years | 0 years | 0 years | 0 years |
| Age, Customized > 75 years | 0 years | 0 years | 0 years |
| Approximal anatomical form | 1.38 scores on a scale STANDARD_DEVIATION 0.7 | 1.29 scores on a scale STANDARD_DEVIATION 0.53 | 1.33 scores on a scale STANDARD_DEVIATION 0.62 |
| Caries, erosion | 1.05 scores on a scale STANDARD_DEVIATION 0.22 | 1.06 scores on a scale STANDARD_DEVIATION 0.24 | 1.06 scores on a scale STANDARD_DEVIATION 0.25 |
| Color match | 1.27 scores on a scale STANDARD_DEVIATION 0.47 | 1.26 scores on a scale STANDARD_DEVIATION 0.5 | 1.26 scores on a scale STANDARD_DEVIATION 0.48 |
| Esthetic anatomical form | 1.22 scores on a scale STANDARD_DEVIATION 0.52 | 1.24 scores on a scale STANDARD_DEVIATION 0.48 | 1.22 scores on a scale STANDARD_DEVIATION 0.5 |
| Fracture and retention | 1.10 scores on a scale STANDARD_DEVIATION 0.46 | 1.08 scores on a scale STANDARD_DEVIATION 0.31 | 1.09 scores on a scale STANDARD_DEVIATION 0.39 |
| Marginal adaptation | 1.25 scores on a scale STANDARD_DEVIATION 0.58 | 1.16 scores on a scale STANDARD_DEVIATION 0.4 | 1.21 scores on a scale STANDARD_DEVIATION 0.5 |
| Marginal discoloration | 1.16 scores on a scale STANDARD_DEVIATION 0.4 | 1.26 scores on a scale STANDARD_DEVIATION 0.5 | 1.18 scores on a scale STANDARD_DEVIATION 0.43 |
| Parodontal reaction | 1.17 scores on a scale STANDARD_DEVIATION 0.38 | 1.2 scores on a scale STANDARD_DEVIATION 0.51 | 1.18 scores on a scale STANDARD_DEVIATION 0.45 |
| Post-operative hypersensitivity | 1.08 scores on a scale STANDARD_DEVIATION 0.28 | 1.06 scores on a scale STANDARD_DEVIATION 0.24 | 1.07 scores on a scale STANDARD_DEVIATION 0.26 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Satisfaction of patient | 1.11 scores on a scale STANDARD_DEVIATION 0.44 | 1.06 scores on a scale STANDARD_DEVIATION 0.24 | 1.09 scores on a scale STANDARD_DEVIATION 0.36 |
| Sex: Female, Male Female | 43 Restorations | 42 Restorations | 85 Restorations |
| Sex: Female, Male Male | 40 Restorations | 38 Restorations | 78 Restorations |
| Surface luster | 1.28 scores on a scale STANDARD_DEVIATION 0.51 | 1.28 scores on a scale STANDARD_DEVIATION 0.45 | 1.28 scores on a scale STANDARD_DEVIATION 0.48 |
| Surface staining | 1.11 scores on a scale STANDARD_DEVIATION 0.35 | 1.1 scores on a scale STANDARD_DEVIATION 0.3 | 1.1 scores on a scale STANDARD_DEVIATION 0.33 |
| Tooth integrity | 1.04 scores on a scale STANDARD_DEVIATION 0.19 | 1.06 scores on a scale STANDARD_DEVIATION 0.24 | 1.05 scores on a scale STANDARD_DEVIATION 0.22 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 0 / 90 |
| other Total, other adverse events | 0 / 90 | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 | 0 / 90 |
Outcome results
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
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venus Pearl | Score for Abrasion | 1.16 scores on a scale | Standard Deviation 0.42 |
| Control Resin-based Filling Material | Score for Abrasion | 1.17 scores on a scale | Standard Deviation 0.43 |
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
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venus Pearl | Score for Adjacent Mucosa | 1.07 scores on a scale | Standard Deviation 0.26 |
| Control Resin-based Filling Material | Score for Adjacent Mucosa | 1.11 scores on a scale | Standard Deviation 0.42 |
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
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venus Pearl | Score for Approximal Anatomical Form | 1.44 scores on a scale | Standard Deviation 0.76 |
| Control Resin-based Filling Material | Score for Approximal Anatomical Form | 1.23 scores on a scale | Standard Deviation 0.51 |
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
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venus Pearl | Score for Caries, Erosion | 1.02 scores on a scale | Standard Deviation 0.13 |
| Control Resin-based Filling Material | Score for Caries, Erosion | 1.08 scores on a scale | Standard Deviation 0.43 |
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
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venus Pearl | Score for Color Match | 1.64 scores on a scale | Standard Deviation 0.7 |
| Control Resin-based Filling Material | Score for Color Match | 1.64 scores on a scale | Standard Deviation 0.68 |
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
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venus Pearl | Score for Esthetic Anatomical Form | 1.49 scores on a scale | Standard Deviation 0.63 |
| Control Resin-based Filling Material | Score for Esthetic Anatomical Form | 1.45 scores on a scale | Standard Deviation 0.64 |
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
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venus Pearl | Score for Fracture and Retention | 1.24 scores on a scale | Standard Deviation 0.58 |
| Control Resin-based Filling Material | Score for Fracture and Retention | 1.32 scores on a scale | Standard Deviation 0.64 |
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
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venus Pearl | Score for Marginal Adaptation | 1.29 scores on a scale | Standard Deviation 0.53 |
| Control Resin-based Filling Material | Score for Marginal Adaptation | 1.42 scores on a scale | Standard Deviation 0.69 |
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
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venus Pearl | Score for Marginal Discoloration | 1.49 scores on a scale | Standard Deviation 0.57 |
| Control Resin-based Filling Material | Score for Marginal Discoloration | 1.47 scores on a scale | Standard Deviation 0.72 |
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
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venus Pearl | Score for Parodontal Reaction | 1.45 scores on a scale | Standard Deviation 0.77 |
| Control Resin-based Filling Material | Score for Parodontal Reaction | 1.36 scores on a scale | Standard Deviation 0.68 |
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
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venus Pearl | Score for Post-operative Hypersensitivity | 1.04 scores on a scale | Standard Deviation 0.19 |
| Control Resin-based Filling Material | Score for Post-operative Hypersensitivity | 1.04 scores on a scale | Standard Deviation 0.19 |
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
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venus Pearl | Score for Satisfaction of Patient | 1.04 scores on a scale | Standard Deviation 0.27 |
| Control Resin-based Filling Material | Score for Satisfaction of Patient | 1.06 scores on a scale | Standard Deviation 0.41 |
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
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venus Pearl | Score for Surface Luster | 1.89 scores on a scale | Standard Deviation 0.6 |
| Control Resin-based Filling Material | Score for Surface Luster | 1.62 scores on a scale | Standard Deviation 0.63 |
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
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venus Pearl | Score for Surface Staining | 1.44 scores on a scale | Standard Deviation 0.54 |
| Control Resin-based Filling Material | Score for Surface Staining | 1.34 scores on a scale | Standard Deviation 0.52 |
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
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venus Pearl | Score for Tooth Integrity | 1.11 scores on a scale | Standard Deviation 0.37 |
| Control Resin-based Filling Material | Score for Tooth Integrity | 1.19 scores on a scale | Standard Deviation 0.44 |