Clinical Evaluation of Lithium Disilicate CAD/CAM Crowns
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Ivoclar Vivadent AG
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- Number of Crowns With Short-term Post-operative Sensitivity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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).
Intervention: Lithium disilicate crowns (Device)
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).
Intervention: Lithium disilicate crowns (Device)
Outcomes
Primary Outcomes
Number of Crowns With Short-term Post-operative Sensitivity
Time Frame: 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 Outcomes
- Quality Criteria (Modified FDI Criteria)(4 weeks)