Clinical Evaluation of Chairside CAD/CAM Nano-ceramic Restorations

Restoration of Posterior Teeth Clinical Trial

Official title:

Clinical Evaluation of Chairside CAD/CAM Nano-ceramic Restorations

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01464294
• Other study ID #: 3M ESPE CR-10-019
• Status: Terminated
• Phase: N/A
• First received: October 27, 2011
• Last updated: January 26, 2015
• Start date: October 2011
• Est. completion date: December 2014

Study information

• Verified date: December 2013
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Study aim is to test whether nano-composite CAD/CAM milled restorations have a similar performance in clinical service to conventional ceramic CAD/CAM restorations.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient 18 years of age or over

• To have at least one carious lesion or defective restoration in a molar or premolar tooth, cavities to be large enough to warrant a milled restoration of either a crown or onlay

• Teeth to be vital and asymptomatic

Exclusion Criteria:

• Devital or sensitive teeth

• Teeth that have had root canal treatment

• Patients with significant untreated dental disease including periodontitis and rampant caries

• Pregnant or lactating women

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Restoration of Posterior Teeth

Intervention

Device:
• Milled ceramic restorations
Restoration of back teeth with milled ceramic crowns or onlays
• Milled nano-composite restorations
Restoration of back teeth with milled crowns or onlays

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical performance	Subjective evaluation of restorations using USPHS criteria	3 years	No
Secondary	Luting cement	Subjective evaluaton of performance of a nano-filled resin luting cement used to cement the study onlays	3 years	No