Full-arch Monolithic Zirconia ISFDP Follow up

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Retrospective Clinical Study Evaluating Full-Arch Monolithic Zirconia Implant Supported Fixed Dental Prosthesis

Conditions
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Edentulous

Intervention / Treatment
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* Device: Monolithic zirconia prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 18 years and older Good physical health (American Society of Anesthesiologist classification I (ASA I) and II (ASA II) to undergo routine comprehensive recall examination ASA I - A normal healthy patient ASA II - A patient with mild systemic health. Able to give informed consent At least one edentulous arch (maxilla and/or mandible) that were treatment planned and restored with full arch MZISFDP by UNC Graduate Prosthodontic clinic and/or UNC Dental Faculty Practice between January 1, 2008- September 1, 2015 Pregnancy status during the time of recall Women of non-childbearing potential - defined as those who have no uterus, ligation of the fallopian tubes, or permanent cessation of ovarian function due to ovarian failure or surgical removal of the ovaries (i.e. permanently sterilized, postmenopausal). Postmenopausal is defined as 12 months with no menses without an alternative medical cause Non-childbearing potential status will be determined with a questionnaire. Women of childbearing potential - Female patient who don't fulfill the non-childbearing potential status will be considered of childbearing potential. Status of pregnancy will be determined by administering urine pregnancy tests If a subject is found to be pregnant and they consent to remaining in the study then any data from the intraoral exam will be included and the subject will be excluded from the radiographic examination. Exclusion Criteria History of radiotherapy in the head and neck region History of intravenous bisphosphonate therapy Medical conditions that contraindicate elective dental therapy and routine recall appointment American Society of Anesthesiologist Classification III (ASA III), IV (ASA IV), V (ASA V) and VI (ASA VI) ASA III - a patient with severe systemic disease ASA IV -a patient with severe systemic disease that is a constant threat to life. ASA V - a moribund patient who is not expected to survive without the operation. ASA VI - a declared brain-dead patient whose organs are being removed for donor purposes. Psychological and/or behavioral conditions that make routine recall appointments very difficult to impossible Known alcohol and/or drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Monolithic zirconia prosthesis<br>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<br>* Edentulous arch subjects treated with a monolithic zirconia implant supported fixed dental prosthesis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Incidence of Biological Complications | 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 | At time of study visit (anywhere from 1-8 years from prosthesis delivery) | 
| Quantitative measurement of bone level | 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. | At time of study visit (anywhere from 1-8 years from prosthesis delivery) | 
| Patient self-reported OHIP-14 satisfaction scores | 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. | At time of study visit (anywhere from 1-8 years from prosthesis delivery) | 
| Patient self-reported QoLFAST-10 scores | 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. | At time of study visit (anywhere from 1-8 years from prosthesis delivery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Monolithic Zirconia, Implant supported prosthesis, Fixed partial denture