NCT04604301

Brief Summary

This investigation will be a clinical trial to study the performance of a newly developed high strength ceramic material for crowns. The ceramic 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. Two adhesive resin cement techniques will be used to hold the crown to the tooth and they will be evaluated for creating sensitivity to the tooth. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Sep 2020Nov 2027

Study Start

First participant enrolled

September 24, 2020

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 27, 2020

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

7.1 years

First QC Date

October 22, 2020

Last Update Submit

March 17, 2026

Conditions

Fractured ToothDecayed ToothUnsatisfactory Restoration of Tooth

Keywords

CrownCeramicCAD/CAM

Outcome Measures

Primary Outcomes (1)

  • Crown failure

    Restoration failure is scored by visual loss of the crown from the tooth requiring replacement of the study crown with a new crown at any time between delivery and five years.

    from delivery of the crown up to 5 years

Secondary Outcomes (3)

  • Crown loss of retention

    from delivery of crown up to 5 years

  • Tooth sensitivity

    from delivery of crown up to 5 years

  • Margin staining

    from delivery of crown up to 5 years

Study Arms (4)

Crown, 1.0mm thickness, Calcium Aluminate Ionomer Cement

EXPERIMENTAL

occlusal thickness of 1.0 mm delivered with a conventional Calcium Aluminate Ionomer cement

Device: Celtra Quatro

Crown, 1.5mm thickness, Calcium Aluminate Ionomer Cement

EXPERIMENTAL

occlusal thickness of 1.5 mm delivered with a conventional Calcium Aluminate Ionomer cement

Device: Celtra Quatro

Crown, 1.0mm thickness, dual cure resin cement

EXPERIMENTAL

occlusal thickness of 1.0 mm delivered with Prime and Bond elect Universal Bond in total etch mode with a dual cure resin cement

Device: Celtra Quatro

Crown, 1.5mm thickness, dual cure resin cement

EXPERIMENTAL

occlusal thickness of 1.5 mm delivered with Prime and Bond elect Universal Bond in total etch mode with a dual cure resin cement

Device: Celtra Quatro

Interventions

Celtra QuatroDEVICE

Full ceramic crowns will be made from the high strength ceramic, Celtra Quatro

Crown, 1.0mm thickness, Calcium Aluminate Ionomer CementCrown, 1.0mm thickness, dual cure resin cementCrown, 1.5mm thickness, Calcium Aluminate Ionomer CementCrown, 1.5mm thickness, dual cure resin cement

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School os Dentistry

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Tooth Fractures

Condition Hierarchy (Ancestors)

Tooth InjuriesTooth DiseasesStomatognathic DiseasesWounds and Injuries

Study Officials

  • Dennis Fasbinder, DDS

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
The final thickness of the restoration was not identified until before treatment started The final cement was not identified in the treatment process until the crown was milled.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 22, 2020

First Posted

October 27, 2020

Study Start

September 24, 2020

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)