Full-arch Monolithic Zirconia ISFDP Follow up

Completed

• Conditions: Edentulous
• Interventions: Device: Monolithic zirconia prosthesis

• Registration Number: NCT02931968
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-11
• Study First Posted: 2016-10-13
• Study Start: 2017-01
• Primary Completion: 2018-11-05
• Study Completion: 2018-11-05
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-21
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Monolithic zirconia prosthesis	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.

Primary Outcome Measures

Name	Time	Method
Percent Incidence of Prosthetic Complications	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)

Secondary Outcome Measures

Name	Time	Method
Percent Incidence of Biological Complications	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	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	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	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.

Trial Locations

Locations (1)

Graduate Prosthodontic Clinic, Dept. of Prosthodontics, UNC School of Dentistry; 🇺🇸 Chapel Hill, North Carolina, United States