Graduate Prosthodontic Clinic, Dept. of Prosthodontics, UNC School of Dentistry
Chapel Hill, North Carolina, 27599, United States
NCT Number: NCT02931968
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.
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Notify Me18 year–99 year
All sexes
Observational
Chapel Hill, North Carolina, 27599, United States
Purpose: A retrospective single-center study to provide scientific data on the clinical performance of full-arch monolithic zirconia implant supported fixed dental prosthesis (MZISFDP).
Participants: Individuals with at least one edentulous dental arch (maxilla/mandible) who were treated in the UNC Graduate Prosthodontic clinic and Dental Faculty Practice between January 1, 2008 to September 1, 2015 with full-arch MZISFDP.
Procedures (methods): This study is designed as a retrospective descriptive study with a single prospective examination of a population of subjects previously restored with full-arch MZISFDPs. An estimated 60 participants will be enrolled in the study. The study includes retrospective data and radiograph collection from dental records as well as data collection from one prospective visit that includes clinical examination, a panoramic radiograph and 2 patient questionnaires.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Edentulous arch subjects treated with a monolithic zirconia implant supported fixed dental prosthesis.
Time frame: At time of study visit (anywhere from 1-8 years from prosthesis delivery)
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)
Time frame: At time of study visit (anywhere from 1-8 years from prosthesis delivery)
Biological complications are going to be reported by number of sites and mm around bone loss and will be analyzed by using descriptive tabular methods; Bleeding on probing, Bone loss around implant fixture
Time frame: At time of study visit (anywhere from 1-8 years from prosthesis delivery)
A standard panoramic radiograph will be obtained to assess hard tissue status around each dental implant supporting the prosthesis, which will be measured by using a software program.
Time frame: At time of study visit (anywhere from 1-8 years from prosthesis delivery)
Oral Health Impact Profile 14 (OHIP-14) will be administered to evaluate patient centered outcomes with regards to prosthesis. Responses are organized into 5 subscales (not at all satisfied, not very satisfied, reasonably satisfied, very satisfied, totally satisfied) and are based on a Likert scale.
Time frame: At time of study visit (anywhere from 1-8 years from prosthesis delivery)
Patient paper questionnaire; Quality of life related to function, aesthetics, socialization, and thoughts about health-behavioral habits (QoLFAST-10) will be administered to evaluate patient centered outcomes with regards to prosthesis. Responses are organized into 5 subscales (strongly disagree, disagree, indifferent, agree, strongly agree) and are based on a Likert scale.
University of North Carolina, Chapel Hill
Other
A Retrospective Clinical Study Evaluating Full-Arch Monolithic Zirconia Implant Supported Fixed Dental Prosthesis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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