Dental Disorders Hard Tissues of TeethNCT06173167
Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns
A study testing Crowns self-adhesively luted and Crowns conventionally cemented in people with Dental Disorders Hard Tissues of Teeth and Dental Diseases, run by Ivoclar Vivadent AG at 1 site in United States.
Trial summary
This investigation will be a randomized, prospective, longitudinal clinical trial to study the clinical performance of a new monolithic, zirconia material with shade, translucency and material graduation for chairside CAD/CAM crowns. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Disorders Hard Tissues of Teeth, Dental Diseases
- What is being tested?
- Crowns self-adhesively luted and Crowns conventionally cemented
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- at least 18 years of age
- at least one carious lesion, defective restoration, or fractured portion of the tooth to be restored on a maxillary or mandibular premolar or molar tooth - Each lesion, fracture, or defective restoration should exhibit sufficient size or loss of tooth structure requiring a full crown restoration.
- tooth should have at least one opposing tooth in occlusion and one adjacent tooth with an intact proximal contact
- No more than ten teeth that are endodontically treated may be included in the study, equally divided between the two groups of crowns. All remaining teeth in the study will test vital and be asymptomatic at the beginning of treatment.
- No more than two restorations will be placed per patient
Who cannot join
- Sensitive teeth
- Teeth with a history of direct or indirect pulp capping procedures
- Patients with significant untreated dental disease to include periodontitis and/or rampant caries
- Women who self-report that they are possibly pregnant, pregnant, or lactating, as elective dental treatment is not indicated at these times
- Patients with a self-reported history of allergies to the materials to be used in the study including composite resin cements or zirconia restorative materials
- Patients unable to return for the recall appointments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109-1078
Dennis J Fasbinder, 734-647-4450, djfas@umich.edu
About this study
This investigation will be a randomized, prospective, longitudinal clinical trial to study the clinical performance of a new monolithic, zirconia material with shade, translucency and material graduation for chairside CAD/CAM crowns. The restorations will be luted either with a self-adhesive luting material or a conventional cement. The crowns will be evaluated for a period of two years.
- Being tested
- Crowns self-adhesively luted, Crowns conventionally cemented
- Keywords
- Dental Caries, Caries
- Medical subject headings
- Stomatognathic Diseases, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crowns self-adhesively lutedDevice
After cavity preparation, the zirconia chairside crown will be placed using SpeedCEM Plus. The excess will be light cured with Bluephase G4 in PreCure mode (950 mW/cm^2). After removal of the excess, the luting material margins will be light-cured again for 20s (1200 mW/cm^2).
Crowns conventionally cementedDevice
After cavity preparation, the zirconia chairside crown will be placed using ZirCAD Cement. The excess cement will be removed in the gel phase, either following light curing (5 - 10 seconds per segment) or following self-curing (approximately 2 min after placement). The restoration will be held in position during final curing that is complete 4 min 30 s after placement.
| Study group | Role | What they receive |
|---|---|---|
| SpeedCEM Plus luted crowns | Experimental | crowns delivered with a self-adhesive, self-curing resin cement (SpeedCEM Plus\Ivoclar Vivadent AG) Receives: Device: Crowns self-adhesively luted |
| ZirCAD Cement cemented crowns | Experimental | crowns delivered with a resin modified glass ionomer cement (ZirCAD Cement\Ivoclar Vivadent AG) Receives: Device: Crowns conventionally cemented |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term Post-operative Sensitivity
assessed by patient's weekly feedback for 4 weeks after the treatment rating sensitivity from 1 "no sensitivity" to 4 "severe discomfort noted routinely with cold or pressure stimulation"
Measured: 4 weeks
Secondary outcomes (1)
Quality Criteria (modified FDI criteria)
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" (e.g. post-operative hypersensitivity, surface lustre, Staining, fracture of material, retension, occlusal contour and wear, and colour match of restorations)
Measured: 1 year to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start8 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Disorders Hard Tissues of 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ivoclar Vivadent AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
- Investigators
- Dennis J. Fasbinder, DDS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173167
- Sponsor's protocol ID
- OTCS11686932
- Other IDs
- HUM00241710
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns
- ClinicalTrials.gov ID
- NCT06173167
- Acronym / sponsor ID
- OTCS11686932
- Keywords
- Dental Caries, Caries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ivoclar Vivadent AGIndustry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Dec 2023 (actual)
- 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.
This investigation will be a randomized, prospective, longitudinal clinical trial to study the clinical performance of a new monolithic, zirconia material with shade, translucency and material graduation for chairside CAD/CAM crowns. The restorations will be luted either with a self-adhesive luting material or a conventional cement. The crowns will be evaluated for a period of two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SpeedCEM Plus luted crowns | Experimental | Device: Crowns self-adhesively lutedcrowns delivered with a self-adhesive, self-curing resin cement (SpeedCEM Plus\Ivoclar Vivadent AG) |
| ZirCAD Cement cemented crowns | Experimental | Device: Crowns conventionally cementedcrowns delivered with a resin modified glass ionomer cement (ZirCAD Cement\Ivoclar Vivadent AG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- at least 18 years of age
- at least one carious lesion, defective restoration, or fractured portion of the tooth to be restored on a maxillary or mandibular premolar or molar tooth - Each lesion, fracture, or defective restoration should exhibit sufficient size or loss of tooth structure requiring a full crown restoration.
- tooth should have at least one opposing tooth in occlusion and one adjacent tooth with an intact proximal contact
- No more than ten teeth that are endodontically treated may be included in the study, equally divided between the two groups of crowns. All remaining teeth in the study will test vital and be asymptomatic at the beginning of treatment.
- No more than two restorations will be placed per patient
Key exclusion criteria (6 listed)
- Sensitive teeth
- Teeth with a history of direct or indirect pulp capping procedures
- Patients with significant untreated dental disease to include periodontitis and/or rampant caries
- Women who self-report that they are possibly pregnant, pregnant, or lactating, as elective dental treatment is not indicated at these times
- Patients with a self-reported history of allergies to the materials to be used in the study including composite resin cements or zirconia restorative materials
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 |
|---|---|---|
| Crowns self-adhesively lutedAfter cavity preparation, the zirconia chairside crown will be placed using SpeedCEM Plus. The excess will be light cured with Bluephase G4 in PreCure mode (950 mW/cm^2). After removal of the excess, the luting material margins will be light-cured again for 20s (1200 mW/cm^2). | Device | SpeedCEM Plus luted crowns |
| Crowns conventionally cementedAfter cavity preparation, the zirconia chairside crown will be placed using ZirCAD Cement. The excess cement will be removed in the gel phase, either following light curing (5 - 10 seconds per segment) or following self-curing (approximately 2 min after placement). The restoration will be held in position during final curing that is complete 4 min 30 s after placement. | Device | ZirCAD Cement cemented crowns |
Primary outcome
Short-term Post-operative Sensitivity
Time frame: 4 weeks
assessed by patient's weekly feedback for 4 weeks after the treatment rating sensitivity from 1 "no sensitivity" to 4 "severe discomfort noted routinely with cold or pressure stimulation"
1 secondary outcome
Quality Criteria (modified FDI criteria)
Time frame: 1 year to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 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.
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 Crowns self-adhesively luted and Crowns conventionally cemented in people with Dental Disorders Hard Tissues of Teeth and Dental Diseases, run by Ivoclar Vivadent AG 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dennis J. Fasbinder, DDS ((734) 647-4450, djfas@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term Post-operative Sensitivity (time frame: 4 weeks). 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 Mar 2024.