NCT02931968|Completed
Full-arch Monolithic Zirconia ISFDP Follow up
A Retrospective Clinical Study Evaluating Full-Arch Monolithic Zirconia Implant Supported Fixed Dental Prosthesis
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A Retrospective Clinical Study Evaluating Full-Arch Monolithic Zirconia Implant Supported Fixed Dental Prosthesis
Sponsor study identifier
observational
22
1 country
1
Study Start
January 2017
Actual (reported)Primary Completion
November 5, 2018
Actual (reported)Study Completion
November 5, 2018
Actual (reported)This study is designed to recall all patients who have received a full-arch monolithic zirconia implant supported fixed dental prosthesis in the University of North Carolina (UNC) School of Dentistry Graduate Prosthodontic and/or Dental Faculty Practice clinics between January 1, 2008 to September 1, 2015. The main purpose is to evaluate the biological and technical complications associated with this form of prosthetic treatment. Additionally patient centered outcomes will be evaluated.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 5, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 11, 2016
Actual (reported)October 13, 2016
Actual (reported)January 2017
Actual (reported)November 5, 2018
Actual (reported)November 5, 2018
Actual (reported)Percent Incidence of Prosthetic Complications
Implant and prosthetic survivals are going to be reported by number of occurrence and will be analyzed by using descriptive tabular methods; Prosthetic screw loosening (number of complications calculated by percent), Repair of prosthesis (zirconia fracture)
At time of study visit (anywhere from 1-8 years from prosthesis delivery)
Percent Incidence of Biological Complications
At time of study visit (anywhere from 1-8 years from prosthesis delivery)
Quantitative measurement of bone level
At time of study visit (anywhere from 1-8 years from prosthesis delivery)
Patient self-reported OHIP-14 satisfaction scores
At time of study visit (anywhere from 1-8 years from prosthesis delivery)
Patient self-reported QoLFAST-10 scores
At time of study visit (anywhere from 1-8 years from prosthesis delivery)
Subjects previously treated with at least one arch (maxilla/mandible) of dental implants restored with a full-arch monolithic zirconia implant supported fixed dental prosthesis will be recalled for clinical and radiographic examination.
Edentulous arch subjects treated with a monolithic zirconia implant supported fixed dental prosthesis.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All adult patients treated in the UNC School of Dentistry Graduate Prosthodontic and/or Dental Faculty Practice clinic(s) between January 1, 2008 to September 1, 2015 with at least one full-arch monolithic zirconia implant supported fixed dental prosthesis.
Graduate Prosthodontic Clinic, Dept. of Prosthodontics, UNC School of Dentistry
Chapel Hill, North Carolina, 27599, United States
Abdulmajeed AA, Lim KG, Narhi TO, Cooper LF. Complete-arch implant-supported monolithic zirconia fixed dental prostheses: A systematic review. J Prosthet Dent. 2016 Jun;115(6):672-677.e1. doi: 10.1016/j.prosdent.2015.08.025. Epub 2016 Jan 23.
Al-Amleh B, Lyons K, Swain M. Clinical trials in zirconia: a systematic review. J Oral Rehabil. 2010 Aug;37(8):641-52. doi: 10.1111/j.1365-2842.2010.02094.x. Epub 2010 Apr 9.
Ingeborg De Kok, DDS MS
UNC Associate Professor
22 participants (actual enrollment reported by the registry).
First Submitted
October 11, 2016
First Posted
October 13, 2016
Study Start
January 2017
Actual (reported)Implant Placement With Simultaneous Gum Grafting
Contact the study team to confirm eligibility.
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Primary Completion
November 5, 2018
Actual (reported)Study Completion
November 5, 2018
Actual (reported)Last Updated
September 23, 2020
Record last verified: 2020-09
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