TetricCAD Crown Clinical Study

Fractured Tooth Clinical Trial

Official title:

Clinical Evaluation of Chairside CAD/CAM Resilient Ceramic Crowns

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03716817
• Other study ID #: HUM00145596
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: October 2026

Study information

• Verified date: September 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: October 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Decayed Tooth
• Dental Caries
• Fractured Tooth
• Tooth Fractures
• Unsatisfactory Restoration of Tooth

Intervention

Device:
• Tetric CAD
Resilient ceramic crowns (Tetric CAD by Ivoclar Vivadent) 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).

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Ivoclar Vivadent AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crown failure	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.	from delivery of the crown up to 5 years
Secondary	Crown loss of retention	Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown.	from delivery of the crown up to 5 years
Secondary	Tooth sensitivity	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.	from delivery of the crown up to 5 years
Secondary	Margin staining	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.	from delivery of the crown up to 5 years