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| Name | Class |
|---|---|
| University of Michigan | OTHER |
| 3M | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| CAD/CAM Crowns | Other | Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-adhesive cement (3M). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lithium disilicate onlays (IPS emaxCAD/Ivoclar) | Device | Restoration of posterior teeth |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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.] | 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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.] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paula Myhre | Solventum | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109-1078 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20628774 | Background | 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. | |
| 14158464 |
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Each lesion or defective restoration exhibited sufficient size to extend at least one-half the intercuspal width of the tooth requiring an onlay or full crown restoration. The onlays covered between one and three cusps on the selected tooth and maintained an occlusal margin. All teeth tested vital and were asymptomatic at the beginning of treatment. No more than two restorations were placed per patient; molar teeth were included prior to premolar teeth.
The patient population was selected from current patients under clinical treatment at the University of Michigan Dental Clinics. Patients were over 18 years of age, of either gender, and of any ethnic background. Each patient had at least one carious lesion or defective restoration to be restored on a maxillary or mandibular premolar or molar tooth.
| ID | Title | Description |
|---|---|---|
| FG000 | CAD/CAM Onlays | 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). |
| FG001 | CAD/CAM Crowns | Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-adhesive cement (3M). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. Of the 58 subjects, 36 had one restoration and 22 had two restorations.
| ID | Title | Description |
|---|---|---|
| BG000 | CAD/CAM Onlays | 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). |
| BG001 | CAD/CAM Crowns |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at time of consent, subjects must be 18 years of age or older. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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.] | Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. | Posted | Count of Units | Restorations | 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years | Restorations | Restorations |
|
From participant's first treatment restoration to subject's completion of the study, an average of 3 years..
Non-device related adverse event reporting was not required beyond the 6-month follow-up visit. Reporting of all device-related and serious adverse events was required throughout the study (3 years).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CAD/CAM Onlays | 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). Lithium disilicate onlays (IPS emaxCAD/Ivoclar): Restoration of posterior teeth |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment | Non-device related. Patient records are locked, not available to dental clinic. No other information is available. Cause and date unknown. |
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Assessments were planned to be examined by two independent clinical evaluators using pre-defined Fédération Dentaire Internationale (FDI) criteria. However, some of the evaluations were made by only a single evaluator. Each occurrence was recorded in the study file as a protocol deviation and was not expected to affect the conclusions of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paula Myhre | Solventum US LLC | 6513842714 | pemyhre1@solventum.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 17, 2020 | Feb 25, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Chairside zirconia crowns (3M) |
| Device |
Restoration of posterior teeth |
|
| 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.] | 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.] | 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.] | 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.] | 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.] | 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.] | 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.] | 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] | 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. | 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] | 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] | 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] | 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.] | 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] | 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] | 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] | 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] | 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years |
| SILNESS 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. |
| 14121956 | Background | LOE 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. |
| Lost to Follow-up |
|
Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-adhesive cement (3M).
| BG002 | Total | Total of all reporting groups |
| Number of Teeth Treated |
|
Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58.
| Mean |
| Standard Deviation |
| years |
| Participants |
|
|
| Sex: Female, Male | Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. | Count of Participants | Participants | No | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Type of restoration | Number of Onlays and Number of Crowns. | Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. | Count of Units | Number of Teeth Treated | No | Number of Teeth Treated |
|
|
| OG001 | CAD/CAM Crowns | Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-adhesive cement (3M). |
|
|
| Secondary | 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.] | Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. | Posted | Count of Units | Restorations | 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years | Restorations | Restorations |
|
|
|
| Secondary | 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.] | Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. | Posted | Count of Units | Restorations | 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years | Restorations | Restorations |
|
|
|
| Secondary | 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.] | Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. | Posted | Count of Units | Restorations | 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years | Restorations | Restorations |
|
|
|
| Secondary | 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.] | Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. | Posted | Count of Units | Restorations | 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years | Restorations | Restorations |
|
|
|
| Secondary | 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.] | Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. | Posted | Count of Units | Restorations | 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years | Restorations | Restorations |
|
|
|
| Secondary | 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.] | Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. | Posted | Count of Units | Restorations | 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years | Restorations | Restorations |
|
|
|
| Secondary | 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.] | Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. | Posted | Count of Units | Restorations | 3 years with assessments at 6 months, 1 year, 2 years, and 3 years | Restorations | Restorations |
|
|
|
| Secondary | 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.] | Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. | Posted | Count of Units | Restorations | 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years | Restorations | Restorations |
|
|
|
| Secondary | 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] | Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. | Posted | Count of Units | Restorations | 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years | Restorations | Restorations |
|
|
|
| Secondary | 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. | Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. | Posted | Count of Units | Restorations | up to 4 weeks after baseline with weekly assessments or until the restoration is reported asymptomatic | Restorations | Restorations |
|
|
|
| Secondary | 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] | Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. | Posted | Count of Units | Restorations | 3 years with assessments at 6 months, 1 year, 2 years, and 3 years | Restorations | Restorations |
|
|
|
| Secondary | 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] | Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. | Posted | Count of Units | Restorations | 3 years with assessments at 6 months, 1 year, 2 years, and 3 years | Restorations | Restorations |
|
|
|
| Secondary | 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] | Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. | Posted | Count of Units | Restorations | 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years | Restorations | Restorations |
|
|
|
| Secondary | 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.] | Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. | Posted | Count of Units | Restorations | 3 years with assessments at 6 months, 1 year, 2 years, and 3 years | Restorations | Restorations |
|
|
|
| Secondary | 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] | Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. | Posted | Count of Units | Restorations | 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years | Restorations | Restorations |
|
|
|
| Secondary | 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] | Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. | Posted | Count of Units | Restorations | 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years | Restorations | Restorations |
|
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|
| Secondary | 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] | Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. | Posted | Count of Units | Restorations | 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years | Restorations | Restorations |
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|
|
| Secondary | 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] | Up to two restorations of either type (onlays and/or crowns) were allowed per subject. Actual overall number of participants treated was 58. | Posted | Count of Units | Restorations | 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years | Restorations | Restorations |
|
|
|
| 1 |
| 35 |
| 1 |
| 35 |
| 0 |
| 35 |
| EG001 | CAD/CAM Crowns | Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-adhesive cement (3M). Chairside zirconia crowns (3M): Restoration of posterior teeth | 0 | 33 | 0 | 33 | 0 | 33 |
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Not provided
| Missed visit / no data |
|
| Failed Onlay / Crown |
|
| Missed visit / no data |
|
| Failed Onlay / Crown |
|
| Missed visit / no data |
|
| Failed Onlay / Crown |
|
| Missed visit / no data |
|
| Failed Onlay / Crown |
|
| Missed visit / no data |
|
| Failed Onlay / Crown |
|
| 6 months post-restoration |
|
| 1 year post-restoration |
|
| 2 years post-restoration |
|
| 3 years post-restoration |
|
| Missed visit / no data |
|
| Not applicable |
|
| Failed onlay / crown |
|
| 6 months post-restoration |
|
| 1 year post-restoration |
|
| 2 years post-restoration |
|
| 3 years post-restoration |
|
| 3: Clinically sufficient |
|
| Missed visit / no data |
|
| Failed Onlay / Crown |
|
| Not Applicable |
|
| 6 months post-restoration |
|
| 1 year post-restoration |
|
| 2 years post-restoration |
|
| 3 years post-restoration |
|
| Missed visit / no data |
|
| Failed Onlay / Crown |
|
| Not Applicable |
|
| 6 months post-restoration |
|
| 1 year post-restoration |
|
| 2 years post-restoration |
|
| 3 years post-restoration |
|
| 3: Clinically sufficient |
|
| Missed visit / no data |
|
| Failed Onlay / Crown |
|
| Not Applicabl |
|
| 6 months post-restoration |
|
| 1 year post-restoration |
|
| 2 years post-restoration |
|
| 3 years post-restoration |
|
| Missed visit / no data |
|
| Failed onlay / crown |
|
| 6 months post-restoration |
|
| 1 year post-restoration |
|
| 2 years post-restoration |
|
| 3 years post-restoration |
|
| 3: Clinically sufficient |
|
| 4: Clinically unsatisfactory |
|
| 5: Clinically poor |
|
| Missed visit / no data |
|
| Failed onlay / crown |
|
| 1 year post-restoration |
|
| 2 years post-restoration |
|
| 3 years post-restoration |
|
| Missed visit / no data |
|
| Failed onlay / crown |
|
| 6 months post-restoration |
|
| 1 year post-restoration |
|
| 2 years post-restoration |
|
| 3 years post-restoration |
|
| Missed visit / no data |
|
| Failed onlay / crown |
|
| 6 months post-restoration |
|
| 1 year post-restoration |
|
| 2 years post-restoration |
|
| 3 years post-restoration |
|
| Clinically sufficient |
|
| Not assessed |
|
| 2 weeks post-restoration |
|
| 3 weeks post-restoration |
|
| Missed visit / no data |
|
| Failed onlay / crown |
|
| 1 year post-restoration |
|
| 2 years post-restoration |
|
| 3 years post-restoration |
|
| Missed visit / no data |
|
| Failed onlay / crown |
|
| 1 year post-restoration |
|
| 2 years post-restoration |
|
| 3 years post-restoration |
|
| Missed visit / no data |
|
| Failed onlay / crown |
|
| 6 months post-restoration |
|
| 1 year post-restoration |
|
| 2 years post-restoration |
|
| 3 years post-restoration |
|
| Missed visit / no data |
|
| Failed onlay / crown |
|
| 1 year post-restoration |
|
| 2 years post-restoration |
|
| 3 years post-restoration |
|
| Missed visit, no data |
|
| Failed onlay / crown |
|
| 6 months post-restoration |
|
| 1 year post-restoration |
|
| 2 years post-restoration |
|
| 3 years post-restoration |
|
| Missed visit, no data |
|
| Failed onlay / crown |
|
| 6 months post-restoration |
|
| 1 year post-restoration |
|
| 2 years post-restoration |
|
| 3 years post-restoration |
|
| Missed visit, no data |
|
| Failed onlay / crown |
|
| 6 months post-restoration |
|
| 1 year post-restoration |
|
| 2 years post-restoration |
|
| 3 years post-restoration |
|
| Missed visit, no data |
|
| Failed onlay / crown |
|
| 6 months post-restoration |
|
| 1 year post-restoration |
|
| 2 years post-restoration |
|
| 3 years post-restoration |
|