Lithium Disilicate Crowns Study

Caries Clinical Trial

Official title:

Clinical Evaluation of Lithium Disilicate CAD/CAM Crowns

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05070416
• Other study ID #: LL3986001
• Secondary ID: HUM00191892
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: October 1, 2027

Study information

• Verified date: September 2021
• Source: Ivoclar Vivadent AG
• Contact: Dennis J. Fasbinder, DDS
• Phone: (734) 647-4450
• Email: djfas[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

CAD-CAM crowns made of lithium disilicate 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 1, 2027
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caries
• Dental Trauma

Intervention

Device:
• 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).

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Ivoclar Vivadent AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality Criteria (modified FDI criteria)	assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" (e.g. post-operative hypersensitivity, surface lustre, Staining, fracture of material, retension, occlusal contour and wear, and colour match of restorations)	Baseline to 5 years