Dental CementsNCT04279574
Clinical Performance of Chairside CAD/CAM Restorations
A study testing Lithium disilicate onlays (IPS emaxCAD/Ivoclar) and Chairside zirconia crowns (3M) in people with Dental Cements and Caries,Dental, run by Solventum US LLC at 1 site in United States.
Trial summary
This investigation will be a longitudinal clinical trial to study the long-term clinical performance of a resin cement for chairside CAD/CAM restorations. Lithium disilicate chairside CAD/CAM onlays will be adhesively bonded using a selective enamel etch technique with an adhesive. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Dental Cements, Caries,Dental
- What is being tested?
- Lithium disilicate onlays (IPS emaxCAD/Ivoclar) and Chairside zirconia crowns (3M)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2020to 22 May 2024
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject in need of crown and/or onlay restoration
- Subject age 18 or above
- Subject with healthy / treated periodontal status (max. degree of movement 1)
- Subject agrees to participate in the study and signed informed consent and HIPAA form
Who cannot join
- Devital or sensitive teeth
- Teeth diagnosed with symptoms of incomplete tooth fracture
- Teeth with prior endodontic treatment of any kind
- Teeth with a history of direct or indirect pulp capping procedures
- Subjects with uncontrolled bruxism or parafunctional habits
- Subject has known allergies to any product used in this study
Show all 9Show fewer
- Subject will not be available for the study duration
- Subjects with significant untreated dental disease to include periodontitis and rampant caries
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan
Ann Arbor, Michigan, 48109-1078
About this study
Official title: Clinical Performance of Chairside CAD/CAM Restorations Using a New Adhesive Cement
This investigation will be a longitudinal clinical trial to study the long-term clinical performance of a resin cement for chairside CAD/CAM restorations. Lithium disilicate chairside CAD/CAM onlays will be adhesively bonded using a selective enamel etch technique with an adhesive.
Full contour zirconia crowns will be cemented using a self-adhesive resin cement.
Read the detailed description
A wide variety of restorative materials are available for dental restorations. The most popular current materials include glass ceramics and full contour zirconia. Glass ceramic materials are generally preferred for their high translucency mimicking enamel-like esthetics of natural teeth and zirconia is preferred for high strength applications. Both of these materials are available for clinical treatment using chairside CAD/CAM technology.
The introduction of an induction sintering oven (SpeedFire oven/Dentsply Sirona) opened the opportunity for chairside full contour zirconia crowns by decreasing sintering times for zirconia to under 30 minutes. 3M Chairside Zirconia (3M) was marketed in 2019 and offers improved esthetics and high strength for monolithic zirconia restorations with an efficient processing time.
This investigation will be a longitudinal clinical trial to study the long-term clinical performance of CAD/CAM restorations. Lithium disilicate chairside CAD/CAM onlays (IPS emaxCAD/Ivoclar) will be adhesively bonded using a selective enamel etch technique with a universal adhesive (3M) and a resin cement (3M). Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-adhesive technique.
- Conditions
- Dental Cements, Caries,Dental
- Being tested
- Lithium disilicate onlays (IPS emaxCAD/Ivoclar), Chairside zirconia crowns (3M)
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithium disilicate onlays (IPS emaxCAD/Ivoclar)Device
Restoration of posterior teeth
Chairside zirconia crowns (3M)Device
Restoration of posterior teeth
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM Onlays | Other | Lithium disilicate chairside CAD/CAM onlays (IPS emaxCAD/Ivoclar) will be adhesively bonded using a selective enamel etch technique with an adhesive (3M) and cement (3M). Receives: Device: Lithium disilicate onlays (IPS emaxCAD/Ivoclar) |
| CAD/CAM Crowns | Other | Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-adhesive cement (3M). Receives: Device: Chairside zirconia crowns (3M) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Retention Scores]
Retention. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) [5b.1 Restoration in place; 5b.5 Complete loss of restoration] Functional property (retention) assessed by visual and/or tactile assessment by two independent examiners.]
Measured: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Secondary outcomes (18)
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Material Fracture Scores]
Material Fracture. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor] Functional properties assessed by visual and/or tactile assessment by two independent examiners.]
Measured: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Form - Mesial]
Approximal anatomical contact form - mesial. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor] Functional property assessed by visual and/or tactile assessment by two independent examiners.]
Measured: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Point - Mesial Scores]
Approximal anatomical contact point - mesial. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor] Functional property assessed by visual and/or tactile assessment by two independent examiners.]
Measured: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Form - Distal Scores]
Approximal Anatomical Contact Form - Distal. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor] Functional property assessed by visual and/or tactile assessment by two independent examiners.]
Measured: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Point - Distal Scores]
Approximal Anatomical Contact Point - Distal. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor] Functional property assessed by visual and/or tactile assessment by two independent examiners.]
Measured: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Occlusal Contour and Wear Scores]
Occlusal contour and wear. Evaluations according to FDI World Dental Federation critera (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor] Functional property assessed by visual and/or tactile assessment by two independent examiners.]
Measured: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Biologic Properties of Restorations (Onlays and Crowns) [Recurrence of Caries, Erosion, Abfraction Scores]
Recurrence of caries, erosion, abfraction. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor] Biological properties assessed by visual and/or tactile assessment by two independent examiners.]
Measured: 3 years with assessments at 6 months, 1 year, 2 years, and 3 years
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Marginal Adaptation Scores]
Marginal Adaptation. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor] Functional property assessed by visual and/or tactile assessment by two independent examiners.]
Measured: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Esthetic Properties of Restorations (Onlays and Crowns) [Surface Luster Scores]
Surface Luster: Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor]
Measured: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Short-term Post-operative Sensitivity (Onlays and Crowns)
Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) [Rating Scale 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor] Biological properties assessed by patient interview.
Measured: up to 4 weeks after baseline with weekly assessments or until the restoration is reported asymptomatic
Gingival Index (Onlays and Crowns)
Loe \& Silness Index, 1963 [0: normal gingiva, 1: mild inflammation and no bleeding, 2: moderate inflammation and bleeding, 3: severe inflammation]
Measured: 3 years with assessments at 6 months, 1 year, 2 years, and 3 years
Plaque Index (Onlays and Crowns)
Silness \& Loe Index, 1964 [0: plaque detectable in the gingival area, 1: plaque recognized only by running tip of probe across tooth surface at gingival crest, 2: moderate accumulation of plaque visible along gingival margin and adjacent tooth, 3: abundance of plaque visible along gingival margin and adjacent tooth]
Measured: 3 years with assessments at 6 months, 1 year, 2 years, and 3 years
Esthetic Properties Clinical Performance of Restorations (Onlays and Crowns) [Aesthetic Anatomical Form]
Aesthetic Anatomical Form. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor] Functional property assessed by visual and/or tactile assessment by two independent examiners]
Measured: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Biologic Properties of Restorations (Onlays and Crowns) [Post-operative Sensitivity]
Post-operative sensitivity. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor] Biological properties assessed by patient interview.]
Measured: 3 years with assessments at 6 months, 1 year, 2 years, and 3 years
Esthetic Properties of Restorations (Onlays and Crowns) [Surface Staining Scores]
Surface Staining: Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor]
Measured: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Esthetic Properties of Restorations (Onlays and Crowns) [Margin Staining Scores]
Margin Staining: Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor]
Measured: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Esthetic Properties of Restorations (Onlays and Crowns) [Color Match and Translucency Scores]
Color Match and Translucency: Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor]
Measured: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Esthetic Properties of Restorations (Onlays and Crowns) [Aesthetic Anatomical Form Scores]
Aesthetic anatomical form: Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor]
Measured: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start26 Aug 2020
- Primary completion22 May 2024
- Study completion22 May 2024
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental CementsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Michigan, 3M
- Responsible party
- Sponsor
- Investigators
- Paula Myhre, Study director, Solventum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279574
- Sponsor's protocol ID
- EM-11-050060
- Status last verified
- Mar 2025
- First submitted
- 13 Feb 2020
- Last updated
- 24 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
PubMed 20628774SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
PubMed 14158464LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
PubMed 14121956
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Chairside CAD/CAM Restorations Using a New Adhesive Cement
- ClinicalTrials.gov ID
- NCT04279574
- Acronym / sponsor ID
- EM-11-050060
- Conditions
- Dental Cements, Caries,Dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Michigan, 3M
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Posted 24 Mar 2025
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 longitudinal clinical trial to study the long-term clinical performance of a resin cement for chairside CAD/CAM restorations. Lithium disilicate chairside CAD/CAM onlays will be adhesively bonded using a selective enamel etch technique with an adhesive.
Full contour zirconia crowns will be cemented using a self-adhesive resin cement.
Detailed description
A wide variety of restorative materials are available for dental restorations. The most popular current materials include glass ceramics and full contour zirconia. Glass ceramic materials are generally preferred for their high translucency mimicking enamel-like esthetics of natural teeth and zirconia is preferred for high strength applications. Both of these materials are available for clinical treatment using chairside CAD/CAM technology.
The introduction of an induction sintering oven (SpeedFire oven/Dentsply Sirona) opened the opportunity for chairside full contour zirconia crowns by decreasing sintering times for zirconia to under 30 minutes. 3M Chairside Zirconia (3M) was marketed in 2019 and offers improved esthetics and high strength for monolithic zirconia restorations with an efficient processing time.
This investigation will be a longitudinal clinical trial to study the long-term clinical performance of CAD/CAM restorations. Lithium disilicate chairside CAD/CAM onlays (IPS emaxCAD/Ivoclar) will be adhesively bonded using a selective enamel etch technique with a universal adhesive (3M) and a resin cement (3M). Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-adhesive technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM Onlays | Other | Device: Lithium disilicate onlays (IPS emaxCAD/Ivoclar)Lithium disilicate chairside CAD/CAM onlays (IPS emaxCAD/Ivoclar) will be adhesively bonded using a selective enamel etch technique with an adhesive (3M) and cement (3M). |
| CAD/CAM Crowns | Other | Device: Chairside zirconia crowns (3M)Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-adhesive cement (3M). |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject in need of crown and/or onlay restoration
- Subject age 18 or above
- Subject with healthy / treated periodontal status (max. degree of movement 1)
- Subject agrees to participate in the study and signed informed consent and HIPAA form
Key exclusion criteria (9 listed)
- Devital or sensitive teeth
- Teeth diagnosed with symptoms of incomplete tooth fracture
- Teeth with prior endodontic treatment of any kind
- Teeth with a history of direct or indirect pulp capping procedures
- Subjects with uncontrolled bruxism or parafunctional habits
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 |
|---|---|---|
| Lithium disilicate onlays (IPS emaxCAD/Ivoclar)Restoration of posterior teeth | Device | CAD/CAM Onlays |
| Chairside zirconia crowns (3M)Restoration of posterior teeth | Device | CAD/CAM Crowns |
Primary outcome
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Retention Scores]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Retention. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) [5b.1 Restoration in place; 5b.5 Complete loss of restoration] Functional property (retention) assessed by visual and/or tactile assessment by two independent examiners.]
18 secondary outcomes
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Material Fracture Scores]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Form - Mesial]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Point - Mesial Scores]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Form - Distal Scores]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Point - Distal Scores]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Occlusal Contour and Wear Scores]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Biologic Properties of Restorations (Onlays and Crowns) [Recurrence of Caries, Erosion, Abfraction Scores]
Time frame: 3 years with assessments at 6 months, 1 year, 2 years, and 3 years
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Marginal Adaptation Scores]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Esthetic Properties of Restorations (Onlays and Crowns) [Surface Luster Scores]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Short-term Post-operative Sensitivity (Onlays and Crowns)
Time frame: up to 4 weeks after baseline with weekly assessments or until the restoration is reported asymptomatic
Gingival Index (Onlays and Crowns)
Time frame: 3 years with assessments at 6 months, 1 year, 2 years, and 3 years
Plaque Index (Onlays and Crowns)
Time frame: 3 years with assessments at 6 months, 1 year, 2 years, and 3 years
Esthetic Properties Clinical Performance of Restorations (Onlays and Crowns) [Aesthetic Anatomical Form]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Biologic Properties of Restorations (Onlays and Crowns) [Post-operative Sensitivity]
Time frame: 3 years with assessments at 6 months, 1 year, 2 years, and 3 years
Esthetic Properties of Restorations (Onlays and Crowns) [Surface Staining Scores]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Esthetic Properties of Restorations (Onlays and Crowns) [Margin Staining Scores]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Esthetic Properties of Restorations (Onlays and Crowns) [Color Match and Translucency Scores]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Esthetic Properties of Restorations (Onlays and Crowns) [Aesthetic Anatomical Form Scores]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20628774Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
- Background: PubMed 14158464SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
- Background: PubMed 14121956LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Dental Cements
Active, not recruiting
A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
Bracket Bonding, Orthodontic Treatment
Not yet recruiting
Clinical Performance of High Viscous Glass Ionomer Cervical Restorations With Silver-Modified Atraumatic Restorative Technique (SMART) Versus Conventional Treatment in Elderly Cancer Patients. (A 12-month Randomized Clinical Trial)
Dental Caries, Cervical Caries
Recruiting
Evaluation of Ceramic Dental Crown Clinical Performance After Conventional Hydrofluoric Acid Etching or Gaseous Plasma Pretreatment
Prosthodontics, Dental Adhesives/Restorations Performance
Active, not recruiting
Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children
Dental Caries, Tooth Injuries
Not yet recruiting
Repair Versus Replacement of Failed Restorations in Primary Teeth
Dental Caries, Restoration Defects
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.
Paula Myhre study director
Solventum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lithium disilicate onlays (IPS emaxCAD/Ivoclar) and Chairside zirconia crowns (3M) in people with Dental Cements and Caries,Dental, 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 9 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 24 Mar 2025. 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 24 Mar 2025). 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?
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Retention Scores] (time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04279574, which also lists 3 linked publications.
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 24 Mar 2025.