Caries, Dental Trauma
Conditions
Brief summary
CAD-CAM crowns made of experimental lithium disilicate (shades A1, A2 and A3) are placed in patients by using either a dual-curing adhesive or a self-adhesive luting material in combination with total etch/universal bonding agent.
Interventions
DEVICELithium disilicate crowns
The study population is separated in two groups. The teeth will be etched in total etch mode with 37% phosphoric acid (Total Etch, Ivoclar Vivadent AG). After the application of Adhese Universal-adhesive (Ivoclar Vivadent AG), MultiCore Flow (Ivoclar Vivadent AG) will be applied. The crowns will be polished, then etched with IPS Ceramic Etching Gel (Ivoclar Vivadent AG) and conditioned with Monobond Plus (Ivoclar Vivadent AG). The crowns will be luted as described for group 1 or 2. A final intraoral polishing step will be done with OptraGloss (Ivoclar Vivadent AG). All required light-curing steps are conducted with Bluephase G4 (Ivoclar Vivadent AG).
Sponsors
University of Michigan
Ivoclar Vivadent AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients will be at least 18 years of age, of either gender, and of any ethnic background. * Each patient should have at least one carious lesion or defective restoration to be restored on a maxillary or mandibular premolar or molar tooth. * Each lesion or defective restoration should exhibit sufficient size or loss of tooth structure requiring a full crown restoration. * The tooth should have at least one opposing tooth in occlusion and one adjacent tooth with an intact proximal contact. * All teeth will test vital and be asymptomatic at the beginning of treatment. No more than two restorations will be placed per patient.
Exclusion criteria
* 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/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 past history of allergies to the materials to be used in the study including composite resin cements or ceramic restorative materials * Patients unable to return for the recall appointments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Crowns With Short-term Post-operative Sensitivity | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality Criteria (Modified FDI Criteria) | 4 weeks | assessed following the FDI criteria on a scale from 1 very good to 5 unacceptable (e.g. surface lustre, Staining, and colour match of restorations) |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from 04.10.2021 to 01.03.2023 in the clinic.
Participants by arm
| Arm | Count |
|---|---|
| Crowns self-adhesively cemented Group 1 receives crowns with an occlusal thickness of 1.5 mm and luted with a self-adhesive, self-curing resin cement (SpeedCem Plus, Ivoclar Vivadent AG).
Lithium disilicate crowns: The study population is separated in two groups. The teeth will be etched in total etch mode with 37% phosphoric acid (Total Etch, Ivoclar Vivadent AG). After the application of Adhese Universal-adhesive (Ivoclar Vivadent AG), MultiCore Flow (Ivoclar Vivadent AG) will be applied. The crowns will be polished, then etched with IPS Ceramic Etching Gel (Ivoclar Vivadent AG) and conditioned with Monobond Plus (Ivoclar Vivadent AG). The crowns will be luted as described for group 1 or 2. A final intraoral polishing step will be done with OptraGloss (Ivoclar Vivadent AG). All required light-curing steps are conducted with Bluephase G4 (Ivoclar Vivadent AG). | 3 |
| Crowns adhesively luted Group 2 receives crowns with an occlusal thickness of 1.2 mm delivered with a dual-curing resin cement (Variolink Esthetic (DC),Ivoclar Vivadent AG).
Lithium disilicate crowns: The study population is separated in two groups. The teeth will be etched in total etch mode with 37% phosphoric acid (Total Etch, Ivoclar Vivadent AG). After the application of Adhese Universal-adhesive (Ivoclar Vivadent AG), MultiCore Flow (Ivoclar Vivadent AG) will be applied. The crowns will be polished, then etched with IPS Ceramic Etching Gel (Ivoclar Vivadent AG) and conditioned with Monobond Plus (Ivoclar Vivadent AG). The crowns will be luted as described for group 1 or 2. A final intraoral polishing step will be done with OptraGloss (Ivoclar Vivadent AG). All required light-curing steps are conducted with Bluephase G4 (Ivoclar Vivadent AG). | 5 |
| Total | 8 |
Baseline characteristics
| Characteristic | Crowns self-adhesively cemented | Crowns adhesively luted | Total |
|---|---|---|---|
| Age, Customized > 18 years | 3 participants | 5 participants | 8 participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 5 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 0 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 5 |
| other Total, other adverse events | 0 / 3 | 0 / 5 |
| serious Total, serious adverse events | 0 / 3 | 0 / 5 |
Outcome results
Primary
Number of Crowns With 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
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Crowns self-adhesively cemented | Number of Crowns With Short-term Post-operative Sensitivity | 0 Crowns |
| Crowns adhesively luted | Number of Crowns With Short-term Post-operative Sensitivity | 0 Crowns |
Secondary
Quality Criteria (Modified FDI Criteria)
assessed following the FDI criteria on a scale from 1 very good to 5 unacceptable (e.g. surface lustre, Staining, and colour match of restorations)
Time frame: 4 weeks
Population: The clinical trial was early terminated and therefore, only the quality criteria of some participants could be assessed in detail.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Crowns self-adhesively cemented | Quality Criteria (Modified FDI Criteria) | FDI 3 Colour, FDI Score 1 | 2 Crowns |
| Crowns self-adhesively cemented | Quality Criteria (Modified FDI Criteria) | FDI 1 Surface Luster, FDI Score 2-5 | 0 Crowns |
| Crowns self-adhesively cemented | Quality Criteria (Modified FDI Criteria) | FDI 2 Surface Staining, FDI Score 1 | 3 Crowns |
| Crowns self-adhesively cemented | Quality Criteria (Modified FDI Criteria) | FDI 2 Surface Staining, FDI Score 2-5 | 0 Crowns |
| Crowns self-adhesively cemented | Quality Criteria (Modified FDI Criteria) | FDI 3 Colour, FDI Score 2 | 1 Crowns |
| Crowns self-adhesively cemented | Quality Criteria (Modified FDI Criteria) | FDI 3 Colour, FDI Score 3-5 | 0 Crowns |
| Crowns self-adhesively cemented | Quality Criteria (Modified FDI Criteria) | FDI 6 Marginal Adaption, FDI Score 1 | 3 Crowns |
| Crowns self-adhesively cemented | Quality Criteria (Modified FDI Criteria) | FDI 6 Marginal Adaption, FDI Score 2-5 | 0 Crowns |
| Crowns self-adhesively cemented | Quality Criteria (Modified FDI Criteria) | FDI 8 Approximal anatomical form, FDI Score 1 | 3 Crowns |
| Crowns self-adhesively cemented | Quality Criteria (Modified FDI Criteria) | FDI 8 Approximal anatomical form, FDI Score 2-5 | 0 Crowns |
| Crowns self-adhesively cemented | Quality Criteria (Modified FDI Criteria) | FDI 10 Patient view, FDI Score 1 | 3 Crowns |
| Crowns self-adhesively cemented | Quality Criteria (Modified FDI Criteria) | FDI 10 Patient view, FDI Score 2-5 | 0 Crowns |
| Crowns self-adhesively cemented | Quality Criteria (Modified FDI Criteria) | FDI 1 Surface Luster, FDI Score 1 | 3 Crowns |
| Crowns adhesively luted | Quality Criteria (Modified FDI Criteria) | FDI 10 Patient view, FDI Score 1 | 5 Crowns |
| Crowns adhesively luted | Quality Criteria (Modified FDI Criteria) | FDI 1 Surface Luster, FDI Score 1 | 5 Crowns |
| Crowns adhesively luted | Quality Criteria (Modified FDI Criteria) | FDI 6 Marginal Adaption, FDI Score 1 | 5 Crowns |
| Crowns adhesively luted | Quality Criteria (Modified FDI Criteria) | FDI 1 Surface Luster, FDI Score 2-5 | 0 Crowns |
| Crowns adhesively luted | Quality Criteria (Modified FDI Criteria) | FDI 8 Approximal anatomical form, FDI Score 2-5 | 0 Crowns |
| Crowns adhesively luted | Quality Criteria (Modified FDI Criteria) | FDI 2 Surface Staining, FDI Score 1 | 5 Crowns |
| Crowns adhesively luted | Quality Criteria (Modified FDI Criteria) | FDI 6 Marginal Adaption, FDI Score 2-5 | 0 Crowns |
| Crowns adhesively luted | Quality Criteria (Modified FDI Criteria) | FDI 2 Surface Staining, FDI Score 2-5 | 0 Crowns |
| Crowns adhesively luted | Quality Criteria (Modified FDI Criteria) | FDI 3 Colour, FDI Score 1 | 5 Crowns |
| Crowns adhesively luted | Quality Criteria (Modified FDI Criteria) | FDI 10 Patient view, FDI Score 2-5 | 0 Crowns |
| Crowns adhesively luted | Quality Criteria (Modified FDI Criteria) | FDI 3 Colour, FDI Score 2 | 0 Crowns |
| Crowns adhesively luted | Quality Criteria (Modified FDI Criteria) | FDI 8 Approximal anatomical form, FDI Score 1 | 5 Crowns |
| Crowns adhesively luted | Quality Criteria (Modified FDI Criteria) | FDI 3 Colour, FDI Score 3-5 | 0 Crowns |