Lithium Disilicate Crowns Study

Not Applicable

Not yet recruiting

• Conditions: Caries; Dental Trauma

• Registration Number: NCT05070416
• Lead Sponsor: Ivoclar Vivadent AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-09-27
• Last Update Submitted: 2021-09-27
• Study Start: 2021-10-01
• Study First Posted: 2021-10-07
• Last Update Posted: 2021-10-07
• Primary Completion: 2022-02-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Quality Criteria (modified FDI criteria)	Baseline to 5 years	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)

Trial Locations

Locations (1)

University of Michigan School of Dentistry; 🇺🇸 Ann Arbor, Michigan, United States