Full-arch Monolithic Zirconia ISFDP Follow up
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|ClinicalTrials.gov Identifier: NCT02931968|
Recruitment Status : Active, not recruiting
First Posted : October 13, 2016
Last Update Posted : September 13, 2019
|Condition or disease||Intervention/treatment|
|Edentulous||Device: Monolithic zirconia prosthesis|
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.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||A Retrospective Clinical Study Evaluating Full-Arch Monolithic Zirconia Implant Supported Fixed Dental Prosthesis|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Monolithic zirconia prosthesis
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.
Device: Monolithic zirconia prosthesis
Edentulous arch subjects treated with a monolithic zirconia implant supported fixed dental prosthesis.
- Percent Incidence of Prosthetic Complications [ 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)
- Percent Incidence of Biological Complications [ 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
- Quantitative measurement of bone level [ 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.
- Patient self-reported OHIP-14 satisfaction scores [ 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.
- Patient self-reported QoLFAST-10 scores [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931968
|United States, North Carolina|
|Graduate Prosthodontic Clinic, Dept. of Prosthodontics, UNC School of Dentistry|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Ingeborg De Kok, DDS MS||UNC Associate Professor|