Trial Outcomes & Findings for Lithium Disilicate Crowns Study (NCT NCT05070416)
NCT ID: NCT05070416
Last Updated: 2025-10-23
Results Overview
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"
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
4 weeks
Results posted on
2025-10-23
Participant Flow
Patients were recruited from 04.10.2021 to 01.03.2023 in the clinic.
Unit of analysis: crowns
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
3 3
|
5 5
|
|
Overall Study
COMPLETED
|
3 3
|
5 5
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Crowns self-adhesively cemented
n=3 Participants
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).
|
Crowns adhesively luted
n=5 Participants
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).
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
> 18 years
|
3 participants
n=3 Participants
|
5 participants
n=5 Participants
|
8 participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=3 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=8 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 4 weeksassessed 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"
Outcome measures
| Measure |
Crowns self-adhesively cemented
n=3 Crowns
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).
|
Crowns adhesively luted
n=5 Crowns
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).
|
|---|---|---|
|
Number of Crowns With Short-term Post-operative Sensitivity
|
0 Crowns
|
0 Crowns
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The clinical trial was early terminated and therefore, only the quality criteria of some participants could be assessed in detail.
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)
Outcome measures
| Measure |
Crowns self-adhesively cemented
n=3 Crowns
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).
|
Crowns adhesively luted
n=5 Crowns
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).
|
|---|---|---|
|
Quality Criteria (Modified FDI Criteria)
FDI 1 Surface Luster, FDI Score 1
|
3 Crowns
|
5 Crowns
|
|
Quality Criteria (Modified FDI Criteria)
FDI 1 Surface Luster, FDI Score 2-5
|
0 Crowns
|
0 Crowns
|
|
Quality Criteria (Modified FDI Criteria)
FDI 2 Surface Staining, FDI Score 1
|
3 Crowns
|
5 Crowns
|
|
Quality Criteria (Modified FDI Criteria)
FDI 2 Surface Staining, FDI Score 2-5
|
0 Crowns
|
0 Crowns
|
|
Quality Criteria (Modified FDI Criteria)
FDI 3 Colour, FDI Score 1
|
2 Crowns
|
5 Crowns
|
|
Quality Criteria (Modified FDI Criteria)
FDI 3 Colour, FDI Score 2
|
1 Crowns
|
0 Crowns
|
|
Quality Criteria (Modified FDI Criteria)
FDI 3 Colour, FDI Score 3-5
|
0 Crowns
|
0 Crowns
|
|
Quality Criteria (Modified FDI Criteria)
FDI 6 Marginal Adaption, FDI Score 2-5
|
0 Crowns
|
0 Crowns
|
|
Quality Criteria (Modified FDI Criteria)
FDI 8 Approximal anatomical form, FDI Score 1
|
3 Crowns
|
5 Crowns
|
|
Quality Criteria (Modified FDI Criteria)
FDI 8 Approximal anatomical form, FDI Score 2-5
|
0 Crowns
|
0 Crowns
|
|
Quality Criteria (Modified FDI Criteria)
FDI 10 Patient view, FDI Score 1
|
3 Crowns
|
5 Crowns
|
|
Quality Criteria (Modified FDI Criteria)
FDI 6 Marginal Adaption, FDI Score 1
|
3 Crowns
|
5 Crowns
|
|
Quality Criteria (Modified FDI Criteria)
FDI 10 Patient view, FDI Score 2-5
|
0 Crowns
|
0 Crowns
|
Adverse Events
Crowns self-adhesively cemented
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Crowns adhesively luted
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60