NCT05070416

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

October 4, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 7, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

August 14, 2025

Completed
Last Updated

October 23, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

September 27, 2021

Results QC Date

April 10, 2025

Last Update Submit

September 26, 2025

Conditions

CariesDental Trauma

Outcome Measures

Primary Outcomes (1)

  • 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"

    4 weeks

Secondary Outcomes (1)

  • Quality Criteria (Modified FDI Criteria)

    4 weeks

Study Arms (2)

Crowns self-adhesively cemented

EXPERIMENTAL

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).

Device: Lithium disilicate crowns

Crowns adhesively luted

EXPERIMENTAL

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).

Device: Lithium disilicate crowns

Interventions

Lithium disilicate crownsDEVICE

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 lutedCrowns self-adhesively cemented

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109-1078, United States

Location

Results Point of Contact

Title
Team Leader Study Management
Organization
Ivoclar Vivadent AG
patrizia.elkuch-hoch@ivoclar.com
+4232353780

Study Officials

  • Dennis J. Fasbinder, DDS

    University of Michigan School of Dentistry, Department of Cariology, Restorative Sciences & Endodontics

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2021

First Posted

October 7, 2021

Study Start

October 4, 2021

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

October 23, 2025

Results First Posted

August 14, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)