Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
106 participants
OBSERVATIONAL
2008-12-31
2028-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Metal-Ceramic
Metal Ceramic prosthesis with press on veneer with different thicknesses, different diameters of curvature of gingival embrasure and connector heights.
Metal-Ceramic
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.
Ceramic-Ceramic
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.
Interventions
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Ceramic-Ceramic
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.
Metal-Ceramic
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.
Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
75 Years
ALL
Yes
Sponsors
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National Institute of Dental and Craniofacial Research (NIDCR)
NIH
Ivoclar Vivadent AG
INDUSTRY
Dentsply Sirona Inc.
INDUSTRY
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Josephine F Esquivel-Upshaw, DMD,MS,MS-CI
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Kenneth J Anusavice, PhD, DMD
Role: STUDY_DIRECTOR
University of Florida
Arthur E Clark, PhD, DMD
Role: STUDY_DIRECTOR
University of Florida
Locations
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University of Florida
Gainesville, Florida, United States
Countries
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References
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Esquivel-Upshaw J, Mehler A, Clark A, Neal D, Gonzaga L, Anusavice K. Peri-implant complications for posterior endosteal implants. Clin Oral Implants Res. 2015 Dec;26(12):1390-6. doi: 10.1111/clr.12484. Epub 2014 Sep 27.
Esquivel-Upshaw JF, Mehler A, Clark AE, Neal D, Anusavice KJ. Fracture analysis of randomized implant-supported fixed dental prostheses. J Dent. 2014 Oct;42(10):1335-42. doi: 10.1016/j.jdent.2014.07.001. Epub 2014 Jul 9.
Esquivel-Upshaw JF, Clark AE, Shuster JJ, Anusavice KJ. Randomized clinical trial of implant-supported ceramic-ceramic and metal-ceramic fixed dental prostheses: preliminary results. J Prosthodont. 2014 Feb;23(2):73-82. doi: 10.1111/jopr.12066. Epub 2013 Jun 12.
Esquivel-Upshaw JF, Mecholsky JJ Jr, Clark AE, Jenkins R, Hsu SM, Neal D, Ren F. Factors influencing the survival of implant-supported ceramic-ceramic prostheses: A randomized, controlled clinical trial. J Dent. 2020;103S:100017. doi: 10.1016/j.jjodo.2020.100017. Epub 2020 Apr 17.
Mecholsky JJ, Hsu SM, Jadaan O, Griggs J, Neal D, Clark AE, Xia X, Esquivel-Upshaw JF. Forensic and reliability analyses of fixed dental prostheses. J Biomed Mater Res B Appl Biomater. 2021 Sep;109(9):1360-1368. doi: 10.1002/jbm.b.34796. Epub 2021 Feb 1.
Other Identifiers
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IRB201601767-N
Identifier Type: -
Identifier Source: org_study_id
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