NCT04279574

Brief Summary

This investigation will be a longitudinal clinical trial to study the long-term clinical performance of a resin cement for chairside CAD/CAM restorations. Lithium disilicate chairside CAD/CAM onlays will be adhesively bonded using a selective enamel etch technique with an adhesive. Full contour zirconia crowns will be cemented using a self-adhesive resin cement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 13, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

August 26, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2024

Completed
10 months until next milestone

Results Posted

Study results publicly available

March 24, 2025

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

3.7 years

First QC Date

February 13, 2020

Results QC Date

February 25, 2025

Last Update Submit

March 21, 2025

Conditions

Dental CementsCaries,Dental

Outcome Measures

Primary Outcomes (1)

  • Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Retention Scores]

    Retention. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[5b.1 Restoration in place; 5b.5 Complete loss of restoration\] Functional property (retention) assessed by visual and/or tactile assessment by two independent examiners.\]

    3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years

Secondary Outcomes (18)

  • Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Material Fracture Scores]

    3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years

  • Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Form - Mesial]

    3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years

  • Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Point - Mesial Scores]

    3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years

  • Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Form - Distal Scores]

    3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years

  • Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Point - Distal Scores]

    3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years

  • +13 more secondary outcomes

Study Arms (2)

CAD/CAM Onlays

OTHER

Lithium disilicate chairside CAD/CAM onlays (IPS emaxCAD/Ivoclar) will be adhesively bonded using a selective enamel etch technique with an adhesive (3M) and cement (3M).

Device: Lithium disilicate onlays (IPS emaxCAD/Ivoclar)

CAD/CAM Crowns

OTHER

Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-adhesive cement (3M).

Device: Chairside zirconia crowns (3M)

Interventions

Lithium disilicate onlays (IPS emaxCAD/Ivoclar)DEVICE

Restoration of posterior teeth

CAD/CAM Onlays
Chairside zirconia crowns (3M)DEVICE

Restoration of posterior teeth

CAD/CAM Crowns

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject in need of crown and/or onlay restoration
  • Subject age 18 or above
  • Subject with healthy / treated periodontal status (max. degree of movement 1)
  • Subject agrees to participate in the study and signed informed consent and HIPAA form

You may not qualify if:

  • Devital or sensitive teeth
  • Teeth diagnosed with symptoms of incomplete tooth fracture
  • Teeth with prior endodontic treatment of any kind
  • Teeth with a history of direct or indirect pulp capping procedures
  • Subjects with uncontrolled bruxism or parafunctional habits
  • Subject has known allergies to any product used in this study
  • Subject will not be available for the study duration
  • Subjects with significant untreated dental disease to include periodontitis and rampant caries
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109-1078, United States

Location

Related Publications (3)

  • Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.

    PMID: 20628774BACKGROUND

  • SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

    PMID: 14158464BACKGROUND

  • LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

    PMID: 14121956BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Limitations and Caveats

Assessments were planned to be examined by two independent clinical evaluators using pre-defined Fédération Dentaire Internationale (FDI) criteria. However, some of the evaluations were made by only a single evaluator. Each occurrence was recorded in the study file as a protocol deviation and was not expected to affect the conclusions of the study.

Results Point of Contact

Title
Paula Myhre
Organization
Solventum US LLC
pemyhre1@solventum.com
6513842714

Study Officials

  • Paula Myhre

    Solventum

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2020

First Posted

February 21, 2020

Study Start

August 26, 2020

Primary Completion

May 22, 2024

Study Completion

May 22, 2024

Last Updated

March 24, 2025

Results First Posted

March 24, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)