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Lithium Disilicate (CAD/CAM) Fixed Partial Dentures (FPD) Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03036566
Recruitment Status : Active, not recruiting
First Posted : January 30, 2017
Last Update Posted : January 7, 2019
Sponsor:
Collaborator:
Ivoclar Vivadent AG
Information provided by (Responsible Party):
Dennis Fasbinder, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Missing Tooth Device: Lithium disilicate ceramic (Ivoclar) Not Applicable

Detailed Description:
The study will be composed of 30 bridges placed in adult patients that have been identified as requiring replacement of a single tooth. All the bridges will be made from the same high strength ceramic material (emaxCAD/Ivoclar) using a computer to make the entire bridge. All the crowns will be cemented using the most current marketed version of the manufacturer's adhesive resin cement (MultiLink Automix/Ivoclar). At each recall appointment an evaluation of the bridge will be completed as well as clinical photographs, an intraoral digital scan, and impression of the bridge. The purpose of the study is to measure how well the high strength bridges function over an extended period of time.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Chairside Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Lithium Disilicate Fixed Partial Dentures (FPD)
Study Start Date : March 2014
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arm Intervention/treatment
Experimental: Bridge
Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.
Device: Lithium disilicate ceramic (Ivoclar)
Three unit high strength ceramic bridges replacing a single tooth.
Other Name: fixed partial denture




Primary Outcome Measures :
  1. Bridge failure [ Time Frame: from delivery of the bridge up to 5 years ]
    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.


Secondary Outcome Measures :
  1. Bridge loss of retention [ Time Frame: from delivery of the bridge up to 5 years ]
    Loss of retention is measured as detachment of the bridge from the teeth without fracture of the bridge requiring recementation of the bridge.

  2. Tooth sensitivity [ Time Frame: from delivery of the bridge up to 5 years ]
    Patient described tooth sensitivity on a scale of 1 to 4, where 1 means absence of sensitivity (pain) and four means severe discomfort noted routinely with cold or pressure stimulation.

  3. Margin staining [ Time Frame: from delivery of the bridge up to 5 years ]
    Margin staining is categorized based on modified US Public Health Service criteria using a four point scale where 1 is no staining and 4 is penetrating stain involving more than 50% of the margin of each of the abutment teeth.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • missing one anterior or premolar tooth that is appropriate for replacement with a bridge. The second premolar tooth will be the most distal tooth acceptable as a pontic for inclusion in the study.
  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036566


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Ivoclar Vivadent AG
Investigators
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Principal Investigator: Dennis J Fasbinder, DDS University of Michigan

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Responsible Party: Dennis Fasbinder, Clinical Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03036566     History of Changes
Other Study ID Numbers: HUM00081086
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Tooth Loss
Anodontia
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Tooth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs