Survival of Implant-Supported All-Ceramic Prostheses

NCT ID: NCT01729858

Last Updated: 2025-06-15

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Partial Edentulism Disorder of Prostheses and Implants Dental Prosthesis Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type 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.

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

Intervention Type 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.

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role collaborator

Ivoclar Vivadent AG

INDUSTRY

Sponsor Role collaborator

Dentsply Sirona Inc.

INDUSTRY

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 25263400 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25016139 (View on PubMed)

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.

Reference Type RESULT
PMID: 23758092 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34059304 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33527747 (View on PubMed)

Other Identifiers

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IRB201601767-N

Identifier Type: -

Identifier Source: org_study_id

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