Clinical Evaluation of Chairside CAD/CAM Nano-ceramic Res... | NCT01464294

Studies
Clinical Evaluation of Chairside CAD/CAM Nano-ceramic Restorations

NCT01464294

Sponsor

Solventum US LLC

Status

Terminated

Last Update Posted

Dec 2, 2024Actual

Enrollment

120Actual

Phase

Not provided

Conditions

Restoration of Posterior Teeth

Interventions

Milled ceramic restorations
Milled nano-composite restorations

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

not a required sutudy to be posted

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Oct 27, 2011

First Submission Date that Met QC Criteria

Nov 2, 2011

First Posted Date

Nov 3, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2024

Last Update Posted Date

Dec 2, 2024Actual

Name	Class
3M	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
nano-composite		crowns and onlays	Device: Milled nano-composite restorations
ceramic		crowns & onlays	Device: Milled ceramic restorations

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Milled ceramic restorations	Device	Restoration of back teeth with milled ceramic crowns or onlays	ceramic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical performance	Subjective evaluation of restorations using USPHS criteria	3 years

Secondary Outcomes

Measure	Description	Time Frame
Luting cement	Subjective evaluaton of performance of a nano-filled resin luting cement used to cement the study onlays	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients attending and/or under clinical treatment at the University of Michigan Dental Clinics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dennis Fasbinder, DDS	School of Dentistry, Univ of Michigan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
School of Dentistry, Unversity of Michigan		Ann Arbor	Michigan	48109	United States