TetricCAD Crown Clinical Study

Not Applicable

Active, not recruiting

• Conditions: Decayed Tooth; Fractured Tooth; Unsatisfactory Restoration of Tooth

• Registration Number: NCT03716817
• Lead Sponsor: University of Michigan

Brief Summary

This investigation will be a clinical trial to study the performance of a new resin-based ceramic material for crowns. The material has been approved by the FDA for patient treatment. A computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.

Detailed Description

The study will be composed of 50 crowns placed in adult patients that have been identified as requiring at least one crown on a posterior tooth. A maximum of two crowns per patient will be completed. All the crowns will be made from the same resilient ceramic CAD/CAM block(Tetric CAD/Ivoclar Vivadent). The crowns are placed using an adhesive bonding process including a total etch process with a universal adhesive (Adhese by Ivoclar Vivadent) and dual-cured resin cement (Variolink Esthetic by Ivoclar Vivadent). The crowns are planned to be evaluated at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. At each appointment, an examination of the crown will be completed as well as clinical photographs, an intraoral digital scan, and impression of the crown.

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2018-10-21
• Study First Submitted QC: 2018-10-21
• Study First Posted: 2018-10-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-17
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• must have at least one carious lesion or defective restoration or fractured tooth in a molar or premolar
• reason for restoration should extend more than one-half the intercuspal width of the tooth requiring a full crown restoration
• Teeth to be vital and asymptomatic prior to treatment
• No more than two restorations will be placed per patient. If a patient presents with more than two acceptable teeth for the study, molar teeth will be included prior to premolar teeth.

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 rampant caries
• Pregnant or lactating women
• Patients with a history of allergies to any of the materials to be used in the study
• Patients unable to return for the recall appointments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Crown failure	from delivery of the crown up to 5 years	Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and five years.

Secondary Outcome Measures

Name	Time	Method
Tooth sensitivity	from delivery of the crown up to 5 years	Patient described sensitivity on a scale of 1 to 4, where 1 means absence of sensitivity (pain) and four means severe discomfort noted routinely with cold or pressure stimulation.
Margin staining	from delivery of the crown up to 5 years	Margin staining is categorized based on modified US Public Health Service criteria using a four point scale where 1 is no staining and 4 is penetrating stain involving more than 50% of the margin.
Crown loss of retention	from delivery of the crown up to 5 years	Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown.

Trial Locations

Locations (1)

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