Partial EdentulismNCT01729858
Survival of Implant-Supported All-Ceramic Prostheses
An observational study of Partial Edentulism and Disorder of Prostheses and Implants, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Partial Edentulism, Disorder of Prostheses and Implants, Dental Prosthesis Failure
- What is being tested?
- Ceramic-Ceramic and Metal-Ceramic
- Type of treatment
- Medical device
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients accessing a dental clinic for bridge placement
Who may be able to join
- 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
Who cannot join
- Non compliance Not enough teeth remaining Uncontrolled medical condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Ceramic-Ceramic, Metal-Ceramic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceramic-CeramicDevice
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-CeramicDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Metal-Ceramic | Metal Ceramic prosthesis with press on veneer with different thicknesses, different diameters of curvature of gingival embrasure and connector heights. Receives: 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. Receives: Device: Ceramic-Ceramic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture
Any fracture or chipping of the prostheses reported by the participant or noted at recall periods
Measured: A change from baseline to year 5
Secondary outcomes (1)
Wear of prosthesis and enamel antagonist
Wear of the prosthesis and the opposing enamel will be assessed at the recall appointments
Measured: 6 mos, 1 year, 2 year, 3 year, 4 year, 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startDec 2008
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Partial EdentulismStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), Ivoclar Vivadent AG, Dentsply Sirona Inc.
- Responsible party
- Sponsor
- Investigators
- Josephine F Esquivel-Upshaw, DMD,MS,MS-CI, Principal investigator, University of FloridaKenneth J Anusavice, PhD, DMD, Study director, University of FloridaArthur E Clark, PhD, DMD, Study director, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729858
- Sponsor's protocol ID
- IRB201601767-N
- Status last verified
- Sep 2026
- First submitted
- 14 Nov 2012
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 25263400Esquivel-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.
PubMed 25016139Esquivel-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.
PubMed 23758092Esquivel-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.
PubMed 34059304Mecholsky 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.
PubMed 33527747
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing the Survival of Implant-Supported All-Ceramic Prostheses
- ClinicalTrials.gov ID
- NCT01729858
- Acronym / sponsor ID
- IRB201601767-N
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), Ivoclar Vivadent AG, Dentsply Sirona Inc.
- Study start
- Dec 2008 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metal-Ceramic | – | Device: Metal-CeramicMetal Ceramic prosthesis with press on veneer with different thicknesses, different diameters of curvature of gingival embrasure and connector heights. |
| Ceramic-Ceramic | – | Device: Ceramic-CeramicZirconia computer aided design and computer milled cores with press on veneers with different thicknesses, gingival embrasure diameters and connector heights. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients accessing a dental clinic for bridge placement
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Non compliance Not enough teeth remaining Uncontrolled medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceramic-CeramicZirconia 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. | Device | Ceramic-Ceramic |
| Metal-CeramicMetal 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. | Device | Metal-Ceramic |
Primary outcome
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
1 secondary outcome
Wear of prosthesis and enamel antagonist
Time frame: 6 mos, 1 year, 2 year, 3 year, 4 year, 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Background: PubMed 25263400Esquivel-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.
- Background: PubMed 25016139Esquivel-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.
- Results publication: PubMed 23758092Esquivel-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.
- Derived from this study: PubMed 34059304Esquivel-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.
- Derived from this study: PubMed 33527747Mecholsky 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josephine F Esquivel-Upshaw, DMD,MS,MS-CI principal investigator
University of Florida
Kenneth J Anusavice, PhD, DMD study director
University of Florida
Arthur E Clark, PhD, DMD study director
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Partial Edentulism and Disorder of Prostheses and Implants, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture (time frame: A change from baseline to year 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01729858, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.