Survival of Implant-Supported All-Ceramic Prostheses

NCT01729858 | Active Not Recruiting FDA Device

• 1 other identifier: IRB201601767-N
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Partial Edentulism; Disorder of Prostheses and Implants; Dental Prosthesis Failure

Outcome Measures

Primary Outcomes (1)

• Fracture

  Any fracture or chipping of the prostheses reported by the participant or noted at recall periods

  A change from baseline to year 5

Secondary Outcomes (1)

• Wear of prosthesis and enamel antagonist

  6 mos, 1 year, 2 year, 3 year, 4 year, 5 year

Study Arms (2)

Metal-Ceramic

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

Device: Metal-Ceramic

Ceramic-Ceramic

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

Device: Ceramic-Ceramic

Interventions

Ceramic-Ceramic DEVICE

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.

Ceramic-Ceramic

Metal-Ceramic DEVICE

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.

Metal-Ceramic

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients accessing a dental clinic for bridge placement

You may qualify if:

• 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

You may not qualify if:

• Non compliance Not enough teeth remaining Uncontrolled medical condition

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator
• Ivoclar Vivadent AG: collaborator
• Dentsply Sirona Inc.: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (5)

• 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.

  PMID: 25263400 BACKGROUND

• 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.

  PMID: 25016139 BACKGROUND

• 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.

  PMID: 23758092 RESULT

• 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.

  PMID: 34059304 DERIVED

• 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.

  PMID: 33527747 DERIVED

Study Officials

• Josephine F Esquivel-Upshaw, DMD,MS,MS-CI

  University of Florida

  PRINCIPAL INVESTIGATOR

• Kenneth J Anusavice, PhD, DMD

  University of Florida

  STUDY DIRECTOR

• Arthur E Clark, PhD, DMD

  University of Florida

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 20, 2012
• Study Start: December 1, 2008
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

US (1)