Restoration of Posterior TeethNCT01464294
Clinical Evaluation of Chairside CAD/CAM Nano-ceramic Restorations
An observational study of Restoration of Posterior Teeth, run by Solventum US LLC at 1 site in United States.
Trial summary
Study aim is to test whether nano-composite CAD/CAM milled restorations have a similar performance in clinical service to conventional ceramic CAD/CAM restorations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restoration of Posterior Teeth
- What is being tested?
- Milled ceramic restorations and Milled nano-composite restorations
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients attending and/or under clinical treatment at the University of Michigan Dental Clinics
Who may be able to join
- Patient 18 years of age or over
- To have at least one carious lesion or defective restoration in a molar or premolar tooth, cavities to be large enough to warrant a milled restoration of either a crown or onlay
- Teeth to be vital and asymptomatic
Who cannot join
- Devital or sensitive teeth
- Teeth that have had root canal treatment
- Patients with significant untreated dental disease including periodontitis and rampant caries
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Dentistry, Unversity of Michigan
Ann Arbor, Michigan, 48109
About this study
Study aim is to test whether nano-composite CAD/CAM milled restorations have a similar performance in clinical service to conventional ceramic CAD/CAM restorations.
- Conditions
- Restoration of Posterior Teeth
- Being tested
- Milled ceramic restorations, Milled nano-composite restorations
- Keywords
- CAD/CAM, crowns, onlays, composite block, milled restorations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milled ceramic restorationsDevice
Also called Empress CAD/CAM leucite porcelain (Ivoclar Vivadent)
Restoration of back teeth with milled ceramic crowns or onlays
Milled nano-composite restorationsDevice
Also called Lava Ultimate CAD/CAM Restorative (3M ESPE)
Restoration of back teeth with milled crowns or onlays
| Study group | Role | What they receive |
|---|---|---|
| nano-composite | crowns and onlays Receives: Device: Milled nano-composite restorations | |
| ceramic | crowns \& onlays Receives: Device: Milled ceramic restorations |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical performance
Subjective evaluation of restorations using USPHS criteria
Measured: 3 years
Secondary outcomes (1)
Luting cement
Subjective evaluaton of performance of a nano-filled resin luting cement used to cement the study onlays
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: not a required sutudy to be posted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restoration of Posterior TeethStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 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, School of Dentistry, Univ of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464294
- Sponsor's protocol ID
- 3M ESPE CR-10-019
- Status last verified
- Nov 2024
- First submitted
- 27 Oct 2011
- Last updated
- 2 Dec 2024
- Results posted
- No
- 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 Chairside CAD/CAM Nano-ceramic Restorations
- ClinicalTrials.gov ID
- NCT01464294
- Acronym / sponsor ID
- 3M ESPE CR-10-019
- Conditions
- Restoration of Posterior Teeth
- Keywords
- CAD/CAM, crowns, onlays, composite block, milled restorations
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: not a required sutudy to be posted
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Oct 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Nov 2011 (estimated)
- Results
- Not posted in the source record
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 test whether nano-composite CAD/CAM milled restorations have a similar performance in clinical service to conventional ceramic CAD/CAM restorations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nano-composite | – | Device: Milled nano-composite restorationscrowns and onlays |
| ceramic | – | Device: Milled ceramic restorationscrowns \& onlays |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending and/or under clinical treatment at the University of Michigan Dental Clinics
Key inclusion criteria (3 listed)
- Patient 18 years of age or over
- To have at least one carious lesion or defective restoration in a molar or premolar tooth, cavities to be large enough to warrant a milled restoration of either a crown or onlay
- Teeth to be vital and asymptomatic
Key exclusion criteria (4 listed)
- Devital or sensitive teeth
- Teeth that have had root canal treatment
- Patients with significant untreated dental disease including periodontitis and rampant caries
- 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 |
|---|---|---|
| Milled ceramic restorationsAlso: Empress CAD/CAM leucite porcelain (Ivoclar Vivadent)Restoration of back teeth with milled ceramic crowns or onlays | Device | ceramic |
| Milled nano-composite restorationsAlso: Lava Ultimate CAD/CAM Restorative (3M ESPE)Restoration of back teeth with milled crowns or onlays | Device | nano-composite |
Primary outcome
clinical performance
Time frame: 3 years
Subjective evaluation of restorations using USPHS criteria
1 secondary outcome
Luting cement
Time frame: 3 years
Results and safety
The study was stopped early (reason given: not a required sutudy to be posted). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
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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
School of Dentistry, Univ of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Restoration of Posterior Teeth, 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 3 inclusion and 4 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?
The study was stopped early (reason given: not a required sutudy to be posted). Results are not available in the source record.
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 (time frame: 3 years). 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.