Fractured ToothNCT03036579
Celtra Duo Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Dental Crown Study
A study testing Celtra Duo in people with Fractured Tooth and Decayed Tooth, run by University of Michigan at 1 site in United States.
Trial summary
This investigation will be a clinical trial to study the performance of a newly developed high strength ceramic material for crowns. The ceramic has been approved by the FDA for patient treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractured Tooth, Decayed Tooth, Unsatisfactory Restoration of Tooth
- What is being tested?
- Celtra Duo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Sep 2019
- 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
- must have at least one carious lesion or defective restoration or fractured tooth in a molar or premolar
- reason for restoration should extend more than one-half the intercuspal width of the tooth requiring a full crown restoration
- Teeth to be vital and asymptomatic prior to treatment
- No more than two restorations will be placed per patient. If a patient presents with more than two acceptable teeth for the study, molar teeth will be included prior to premolar teeth.
Who cannot join
- Devital or sensitive teeth
- Teeth with prior endodontic treatment of any kind
- Teeth with a history of direct or indirect pulp capping procedures
- Patients with significant untreated dental disease to include periodontitis and rampant caries
- Pregnant or lactating women
- Patients with a history of allergies to any of the materials to be used in the study
- Patients unable to return for the recall appointments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Chairside Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Zirconia-reinforced Lithium Silicate Ceramic Crowns
This investigation will be a clinical trial to study the performance of a newly developed high strength ceramic material for crowns. The ceramic has been approved by the FDA for patient treatment. A computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. Two adhesive resin cement techniques will be used to hold the crown to the tooth and they will be evaluated for creating sensitivity to the tooth. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.
Read the detailed description
The study will be composed of two groups of 50 crowns placed in adult patients that have been identified as requiring at least one crown on a posterior tooth. A maximum of two crowns per patient will be completed. All the crowns will be made from the same high strength ceramic material (Celtra Duo/Dentsply Sirona). The two groups of crowns will be made using two different processes to create the surface texture and finish for the crown. One group of Celtra Duo crowns (Group 1) will be glaze-fired in a porcelain oven and the second group (Group 2) will be hand-polished. All the crowns will be cemented using two adhesive techniques. All of the oven-fired, glazed crowns will be cemented using the self-etching, self-adhesive resin cement technique (Calibra Universal Cement/Dentsply). All of the hand polished crowns will be cemented using an adhesive bonding technique using Prime \& Bond Elect (Dentsply) with a dual cured resin cement (Calibra Ceram/Dentsply). The crowns are planned to be evaluated at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. At each appointment an examination of the crown will be completed as well as clinical photographs, an intraoral digital scan, and impression of the crown.
- Being tested
- Celtra Duo
- Keywords
- CAD/CAM, Ceramic, Crown
- Medical subject headings
- Tooth Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celtra DuoDevice
Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
| Study group | Role | What they receive |
|---|---|---|
| Glazed Fired, Calibra Céram | Experimental | Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement Receives: Device: Celtra Duo |
| Hand Polished, Calibra Universal | Experimental | Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement Receives: Device: Celtra Duo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crown Failure
Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and three years.
Measured: from delivery of the crown up to 3 years
Secondary outcomes (3)
Crown Loss of Retention
Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown.
Measured: 3 years
Tooth Sensitivity
Tooth Sensitivity is evaluated as either "0" if the subject reports that there is NO sensitivity for the tooth with the study crown, or "1" if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure. The better outcome is to have NO tooth sensitivity. The number of teeth with tooth sensitivity are listed below.
Measured: 3 years
Margin Staining
Margin Staining is evaluated as either "0" if there is NO staining at the crown margin where it meets the tooth, or "1" if there IS staining at the crown margin where it meets the tooth. The better outcome is to have NO margin staining. The number of teeth with margin staining are listed below.
Measured: from delivery of the crown up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startNov 2015
- Primary completionSep 2019
- Study completionSep 2019
Why it stopped: COVID, loss of funding
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 Fractured ToothStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Care provider
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Inc.
- Responsible party
- Principal investigator, Dennis J. Fasbinder, DDS, University of Michigan
- Investigators
- Dennis J Fasbinder, DDS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036579
- Sponsor's protocol ID
- HUM00103921
- Status last verified
- Mar 2023
- First submitted
- 26 Jan 2017
- Last updated
- 13 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Chairside Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Zirconia-reinforced Lithium Silicate Ceramic Crowns
- ClinicalTrials.gov ID
- NCT03036579
- Acronym / sponsor ID
- HUM00103921
- Keywords
- CAD/CAM, Ceramic, Crown
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID, loss of funding
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Dentsply Sirona Inc.
- Study start
- Nov 2015
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Posted 13 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation will be a clinical trial to study the performance of a newly developed high strength ceramic material for crowns. The ceramic has been approved by the FDA for patient treatment. A computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. Two adhesive resin cement techniques will be used to hold the crown to the tooth and they will be evaluated for creating sensitivity to the tooth. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.
Detailed description
The study will be composed of two groups of 50 crowns placed in adult patients that have been identified as requiring at least one crown on a posterior tooth. A maximum of two crowns per patient will be completed. All the crowns will be made from the same high strength ceramic material (Celtra Duo/Dentsply Sirona). The two groups of crowns will be made using two different processes to create the surface texture and finish for the crown. One group of Celtra Duo crowns (Group 1) will be glaze-fired in a porcelain oven and the second group (Group 2) will be hand-polished. All the crowns will be cemented using two adhesive techniques. All of the oven-fired, glazed crowns will be cemented using the self-etching, self-adhesive resin cement technique (Calibra Universal Cement/Dentsply). All of the hand polished crowns will be cemented using an adhesive bonding technique using Prime \& Bond Elect (Dentsply) with a dual cured resin cement (Calibra Ceram/Dentsply). The crowns are planned to be evaluated at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. At each appointment an examination of the crown will be completed as well as clinical photographs, an intraoral digital scan, and impression of the crown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glazed Fired, Calibra Céram | Experimental | Device: Celtra DuoCeltra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement |
| Hand Polished, Calibra Universal | Experimental | Device: Celtra DuoCeltra Duo crowns will be hand-polished and cemented with Calibra Universal Cement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- must have at least one carious lesion or defective restoration or fractured tooth in a molar or premolar
- reason for restoration should extend more than one-half the intercuspal width of the tooth requiring a full crown restoration
- Teeth to be vital and asymptomatic prior to treatment
- No more than two restorations will be placed per patient. If a patient presents with more than two acceptable teeth for the study, molar teeth will be included prior to premolar teeth.
Key exclusion criteria (7 listed)
- Devital or sensitive teeth
- Teeth with prior endodontic treatment of any kind
- Teeth with a history of direct or indirect pulp capping procedures
- Patients with significant untreated dental disease to include 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 |
|---|---|---|
| Celtra DuoFull ceramic crowns will be made from the high strength ceramic, Celtra Duo. | Device | Glazed Fired, Calibra Céram, Hand Polished, Calibra Universal |
Primary outcome
Crown Failure
Time frame: from delivery of the crown up to 3 years
Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and three years.
3 secondary outcomes
Crown Loss of Retention
Time frame: 3 years
Tooth Sensitivity
Time frame: 3 years
Margin Staining
Time frame: from delivery of the crown up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 J Fasbinder, DDS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Celtra Duo in people with Fractured Tooth and Decayed Tooth, run by University of Michigan 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 13 Apr 2023. 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 13 Apr 2023). 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?
Crown Failure (time frame: from delivery of the crown up to 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 13 Apr 2023.