DecayNCT01278862
Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns
A study testing DVS veneer and Conventional Veneer in people with Decay, run by Solventum US LLC at 1 site in United States.
Trial summary
Study aim is to compare Lava Computer Aided Design / Computer Aided Milling Computer Aided Machining (CAD/CAM)crowns that are veneered (covered) with porcelain that has been milled using CAD/CAM, with similar CAD/CAM Lava crowns that have been veneered with a hand fabricated porcelain covering. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Decay
- What is being tested?
- DVS veneer and Conventional Veneer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Mar 2014
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age.
- Have at least one decayed back tooth in need of a crown
- Study tooth to be an upper or lower premolar or molar tooth/ teeth
- Study tooth to be vital and asymptomatic at start of study
Who cannot join
- Teeth which are non vital, have had root canal treatment
- Teeth which are pulp capped
- Sensitive teeth
- Significant untreated dental disease including periodontitis and rampant decay
- Pregnant or lactating women
- Patients with allergies to any of the materials to be used in the study
- Unable to attend the recall appointments
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Dental School
Ann Arbor, Michigan, 48109-1274
About this study
Study aim is to compare Lava Computer Aided Design / Computer Aided Milling Computer Aided Machining (CAD/CAM)crowns that are veneered (covered) with porcelain that has been milled using CAD/CAM, with similar CAD/CAM Lava crowns that have been veneered with a hand fabricated porcelain covering.
Read the detailed description
Veneers will be randomly allocated to study crowns. Study crowns will be evaluated over three years. The test porcelain veneer is CAD/CAM milled as a veneer shell that is then fused to the CAD/CAM milled Lava crown to make the final crown to be cemented in the patient's mouth. This may be a more predictable technique in the fabrication of Lava crowns than current conventional methods.
- Conditions
- Decay
- Being tested
- DVS veneer, Conventional Veneer
- Keywords
- Crowns, posterior teeth, CAD CAM crowns, digital veneer system, Lava, clinical
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DVS veneerDevice
Also called Lava digital veneer system
CAD/CAM milled porcelain veneer for Lava crown
Conventional VeneerDevice
Also called Lava Crown
CAD/CAM milled Lava crown with lab fabricated veneer
| Study group | Role | What they receive |
|---|---|---|
| DVS veneer | Experimental | veneer made by CAD/CAM method Receives: Device: DVS veneer |
| Conventional veneer | Active comparator | Veneer made by laboratory technician Receives: Device: Conventional Veneer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria
Performance reported as the % of teeth with perfect (alpha/A) scores. USPHS criteria: Color Match ( A=Ideal, B=perceptible mismatch but acceptable, C=obvious mismatch and unacceptable); Margin Adaptation (A=no visible crevice, B=crevice along <50% margin>1mm depth, C=crevice along>50% margin >1mm depth); Margin discoloration (A=none, B=Surface stain non penetrating, C=Penetrating; Surface Finish (A=smooth, B=moderately uniformly rough, C=significant pitts/voids; Crown Fracture (A=none, B=small but repairable, C= coping exposed/complete delamination; Proximal Contact (A=firm resistance to floss/ideal contact, B=light resistance/variable breadth, C=open; Sensitivity (A=none, B= slight but not uncomfortable, C=severe; Caries (A=no evidence, B= evident but repairable, C=evident/not repairable.
Measured: 1 year
Gingival/Periodontal Health Based on Loe & Stillness Index, 1963.
Performance reported as the # of crowns exhibiting 0, 1, 2 and 3 index score. Gingival Index (0=normal, 1=mild inflammation, 2=moderate inflammation, 3=severe inflammation. Plaque Index (0= none, 1= observed only via probe at on tooth surface at gingival crest, 2=moderate accumulation along gingival margin and adjacent tooth, 3= abundant plaque along gingival margin and adjacent tooth.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startNov 2010
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: product no longer on market
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 DecayStudies 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
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Dennis Fasbinder, DDS, Principal investigator, Univ of Michigan School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278862
- Sponsor's protocol ID
- 3M ESPE CR-10-004
- Status last verified
- Nov 2024
- First submitted
- 14 Jan 2011
- Last updated
- 2 Dec 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 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns
- ClinicalTrials.gov ID
- NCT01278862
- Acronym / sponsor ID
- 3M ESPE CR-10-004
- Conditions
- Decay
- Keywords
- Crowns, posterior teeth, CAD CAM crowns, digital veneer system, Lava, clinical
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: product no longer on market
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Nov 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Posted 26 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study aim is to compare Lava Computer Aided Design / Computer Aided Milling Computer Aided Machining (CAD/CAM)crowns that are veneered (covered) with porcelain that has been milled using CAD/CAM, with similar CAD/CAM Lava crowns that have been veneered with a hand fabricated porcelain covering.
Detailed description
Veneers will be randomly allocated to study crowns. Study crowns will be evaluated over three years. The test porcelain veneer is CAD/CAM milled as a veneer shell that is then fused to the CAD/CAM milled Lava crown to make the final crown to be cemented in the patient's mouth. This may be a more predictable technique in the fabrication of Lava crowns than current conventional methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DVS veneer | Experimental | Device: DVS veneerveneer made by CAD/CAM method |
| Conventional veneer | Active comparator | Device: Conventional VeneerVeneer made by laboratory technician |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years of age.
- Have at least one decayed back tooth in need of a crown
- Study tooth to be an upper or lower premolar or molar tooth/ teeth
- Study tooth to be vital and asymptomatic at start of study
Key exclusion criteria (7 listed)
- Teeth which are non vital, have had root canal treatment
- Teeth which are pulp capped
- Sensitive teeth
- Significant untreated dental disease including periodontitis and rampant decay
- Pregnant or lactating women
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 |
|---|---|---|
| DVS veneerAlso: Lava digital veneer systemCAD/CAM milled porcelain veneer for Lava crown | Device | DVS veneer |
| Conventional VeneerAlso: Lava CrownCAD/CAM milled Lava crown with lab fabricated veneer | Device | Conventional veneer |
Primary outcome
Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria
Time frame: 1 year
Performance reported as the % of teeth with perfect (alpha/A) scores. USPHS criteria: Color Match ( A=Ideal, B=perceptible mismatch but acceptable, C=obvious mismatch and unacceptable); Margin Adaptation (A=no visible crevice, B=crevice along <50% margin>1mm depth, C=crevice along>50% margin >1mm depth); Margin discoloration (A=none, B=Surface stain non penetrating, C=Penetrating; Surface Finish (A=smooth, B=moderately uniformly rough, C=significant pitts/voids; Crown Fracture (A=none, B=small but repairable, C= coping exposed/complete delamination; Proximal Contact (A=firm resistance to floss/ideal contact, B=light resistance/variable breadth, C=open; Sensitivity (A=none, B= slight but not uncomfortable, C=severe; Caries (A=no evidence, B= evident but repairable, C=evident/not repairable.
Gingival/Periodontal Health Based on Loe & Stillness Index, 1963.
Time frame: 1 year
Performance reported as the # of crowns exhibiting 0, 1, 2 and 3 index score. Gingival Index (0=normal, 1=mild inflammation, 2=moderate inflammation, 3=severe inflammation. Plaque Index (0= none, 1= observed only via probe at on tooth surface at gingival crest, 2=moderate accumulation along gingival margin and adjacent tooth, 3= abundant plaque along gingival margin and adjacent tooth.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 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.
Dennis Fasbinder, DDS principal investigator
Univ of Michigan School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DVS veneer and Conventional Veneer in people with Decay, run by Solventum US LLC at 1 site in United States.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 26 Dec 2018). 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?
Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria (time frame: 1 year). The study lists 2 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 2 Dec 2024.