Survival of Implant-Supported All-Ceramic Prostheses

June 14, 2023 updated by: University of Florida

Factors Influencing the Survival of Implant-Supported All-Ceramic Prostheses

The purpose of this research study is to identify reasons that cause an all-ceramic bridge to fracture which include the thickness of the bridge material, the type of bridge material and the bite force of the person. This all-ceramic bridge will be compared to a metal-ceramic bridge. The investigators are conducting this study so we can make bridges which can withstand forces in the mouth which tend to break them.

The overall objective of this research is to analyze how properties of ceramic materials and different forces in the mouth interact with each other to affect the longevity of these bridges. These include fracture toughness, elastic modulus of ceramic layers and supporting substrate, core thickness, connector height, wear, loading orientation, and maximum clenching force.

Study Overview

Detailed Description

The long-range goal of the proposed research is to formulate design survival statistics that will aid the dental community in fabricating properly designed prostheses that can predictably survive the oral environment.

Patients who qualify for this study will be randomized (as in chanced with the flip of a coin) into two groups. The first group is a metal-ceramic group where patients will receive a bridge with a metal substructure underneath. The second group is an all-ceramic group where patients will receive a bridge which is made of hard ceramic material. All patients will receive two dental implants which will bond to bone for a period of 4-6 months. An impression or mold of the implants will then be made and a bridge will be fabricated based on the randomization of the patient. Patients will be asked to return at 6 months and yearly thereafter up to 5 years. During these recall appointments, photographs will be taken and impressions of the bridge and other teeth will be made. This will allow us to measure the amount of wear happening with the bridge and the other teeth. The investigators can also examine the amount of bone around the implants as well as the integrity of the bridge.

Study Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients accessing a dental clinic for bridge placement

Description

Inclusion Criteria:

  • Aged between 21-75 years, and no contraindications to dental treatment.
  • Good overall dental health, no active caries, no periodontal disease, and periodontal pocket depths not greater than 4 mm.
  • Missing at least three teeth in the posterior area of the mouth.
  • Natural teeth opposing the edentulous area and a full complement of teeth or restored teeth in all other areas of the mouth
  • Adequate bone height and width at areas of proposed implant sites
  • Adequate interocclusal distance to accommodate prosthesis
  • Good oral hygiene and compliance with oral hygiene instructions as determined by the amount of plaque present on tooth surfaces.
  • Compliance with appointments and willing to pay $2625 for a 3-unit implant supported FDP

Exclusion Criteria:

Non compliance Not enough teeth remaining Uncontrolled medical condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Metal-Ceramic
Metal Ceramic prosthesis with press on veneer with different thicknesses, different diameters of curvature of gingival embrasure and connector heights.

Metal Ceramic prosthesis with press on veneer with different thicknesses, different diameters of curvature of gingival embrasure and connector heights.

Fifty percent of the recruited subjects will receive the metal-ceramic bridges at baseline.

Ceramic-Ceramic
Zirconia computer aided design and computer milled cores with press on veneers with different thicknesses, gingival embrasure diameters and connector heights.

Zirconia computer aided design and computer milled cores with press on veneers with different thicknesses, gingival embrasure diameters and connector heights.

Fifty percent of the recruited subjects will be given a ceramic-ceramic bridge at baseline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fracture
Time Frame: A change from baseline to year 5
Any fracture or chipping of the prostheses reported by the participant or noted at recall periods
A change from baseline to year 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wear of prosthesis and enamel antagonist
Time Frame: 6 mos, 1 year, 2 year, 3 year, 4 year, 5 year
Wear of the prosthesis and the opposing enamel will be assessed at the recall appointments
6 mos, 1 year, 2 year, 3 year, 4 year, 5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Josephine F Esquivel-Upshaw, DMD,MS,MS-CI, University of Florida
  • Study Director: Kenneth J Anusavice, PhD, DMD, University of Florida
  • Study Director: Arthur E Clark, PhD, DMD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2008

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 14, 2012

First Submitted That Met QC Criteria

November 19, 2012

First Posted (Estimated)

November 20, 2012

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IRB201601767-N
  • K23DE018414 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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