CariesNCT01925040
Comparison of 2 Different Resin Based Filling Materials in Posterior Teeth - a Multicenter Study
A study testing Placement of restoration in people with Caries and Unsatisfactory or Defective Restoration of Tooth, run by Heraeus Kulzer GmbH at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caries, Unsatisfactory or Defective Restoration of Tooth
- What is being tested?
- Placement of restoration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2013to Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Oregon Health and Science University-School of Dentistry
Portland, Oregon, 97239
About this study
Official title: Clinical Investigation of a New Nanohybrid Resin Composite Venus Pearl in Class 2 Cavities- a Multi-center Study
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.
Read the 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).
- Being tested
- Placement of restoration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of restorationDevice
Placement of restorations
| Study group | Role | What they receive |
|---|---|---|
| Venus Pearl | Experimental | Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration. Receives: Device: Placement of 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. Receives: Device: Placement of restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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"
Measured: 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
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2022
- Study completionJul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heraeus Kulzer GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Werner Geurtsen, Prof. Dr., Study chair, Hannover Medical SchoolGabriela Ibarra, DDS, MPH, MS, Principal investigator, Oregon Health and Science UniversityWerner Geurtsen, Prof. Dr., Principal investigator, Medical School Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925040
- Sponsor's protocol ID
- HKG-DT-01/2011-SOCO-CLIN
- Status last verified
- Oct 2024
- First submitted
- 15 Aug 2013
- Last updated
- 28 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of a New Nanohybrid Resin Composite Venus Pearl in Class 2 Cavities- a Multi-center Study
- ClinicalTrials.gov ID
- NCT01925040
- Acronym / sponsor ID
- HKG-DT-01/2011-SOCO-CLIN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Heraeus Kulzer GmbHIndustry (pharma, biotech, devices)
- Study start
- Jun 2013 (actual)
- Primary completion
- Jul 2022 (actual)
- Study completion
- Jul 2022 (actual)
- First posted
- 19 Aug 2013 (estimated)
- Results
- Posted 28 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venus Pearl | Experimental | Device: Placement of restorationPlacement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration. |
| control resin-based filling material | Active comparator | Device: Placement of restorationPlacement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placement of restorationPlacement of restorations | Device | Venus Pearl, control resin-based filling material |
Primary outcome
Score for Surface Luster
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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"
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Werner Geurtsen, Prof. Dr. study chair
Hannover Medical School
Gabriela Ibarra, DDS, MPH, MS principal investigator
Oregon Health and Science University
Werner Geurtsen, Prof. Dr. principal investigator
Medical School Hannover
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of restoration in people with Caries and Unsatisfactory or Defective Restoration of Tooth, run by Heraeus Kulzer GmbH at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score for Surface Luster (time frame: 2 years). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.