NCT03036566

Brief Summary

This investigation will be a clinical trial to study the performance of a high strength ceramic material for bridges to replace missing teeth. The ceramic material has been approved by the FDA for patient treatment. A computer technique will be used to make the bridges. The bridges will be cemented using an adhesive resin cement (MultiLink Automix/Ivoclar). The bridges are planned be evaluated for clinical performance at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. The purpose of the study is to measure how well the high strength bridges function over an extended period of time.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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 Start

First participant enrolled

March 1, 2014

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2020

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

April 5, 2023

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

6 years

First QC Date

January 26, 2017

Results QC Date

February 4, 2023

Last Update Submit

July 16, 2024

Conditions

Missing Tooth

Outcome Measures

Primary Outcomes (1)

  • Bridge Failure

    Bridge failure includes fracture of the bridge or loss of the bridge requiring placement of a new bridge at any time between delivery and five years.

    from delivery of the bridge up to 5 years

Secondary Outcomes (3)

  • Bridge Loss of Retention

    from delivery of the bridge up to 5 years

  • Number of Bridges Associate With Tooth Sensitivity

    from delivery of the bridge up to 5 years

  • Number of Bridges Associated With Margin Staining

    from delivery of the bridge up to 5 years

Study Arms (1)

Bridge

EXPERIMENTAL

Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.

Device: Lithium disilicate ceramic (Ivoclar)

Interventions

Lithium disilicate ceramic (Ivoclar)DEVICE

Three unit high strength ceramic bridges replacing a single tooth.

Also known as: fixed partial denture
Bridge

Eligibility Criteria

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

You may qualify if:

  • healthy periodontal status for the adjacent abutment teeth with 1:1 crown:root ratio
  • abutment teeth must be asymptomatic prior to treatment
  • Endodontically treated teeth will be acceptable for abutments as long as nonmetallic cores can be placed to retain the FPD since the lithium disilicate will be bonded to the abutments.
  • no more than one bridge will be placed per patient. If a patient presents with more than one missing teeth acceptable for the study, premolar teeth will be included prior to anterior teeth. Each bridge will be three units and include only one missing tooth.

You may not qualify if:

  • sensitive abutment teeth
  • teeth with a history of direct or indirect pulp capping procedures
  • patients with significant untreated dental disease to include periodontitis and caries
  • pregnant or lactating women
  • patients with allergies to any material in the study
  • patients unable to return for recall appointments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Anodontia

Interventions

Denture, Partial, Fixed

Condition Hierarchy (Ancestors)

Tooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Denture, PartialDenturesDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Results Point of Contact

Title
Dennis J. Fasbinder, DDS
Organization
University of Michigan
djfas@umich.edu
7346474450

Study Officials

  • Dennis J Fasbinder, DDS

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 26, 2017

First Posted

January 30, 2017

Study Start

March 1, 2014

Primary Completion

March 5, 2020

Study Completion

March 5, 2020

Last Updated

July 25, 2024

Results First Posted

April 5, 2023

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)