Clinical trial NCT02931968: Full-arch Monolithic Zirconia ISFDP Follow up
Official title: A Retrospective Clinical Study Evaluating Full-Arch Monolithic Zirconia Implant Supported Fixed Dental Prosthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Edentulous
Keywords: Monolithic Zirconia
Implant supported prosthesis
Fixed partial denture
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

  1. ASA I - A normal healthy patient
  2. 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

  1. 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.
  2. 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)

  1. ASA III - a patient with severe systemic disease
  2. ASA IV -a patient with severe systemic disease that is a constant threat to life.
  3. ASA V - a moribund patient who is not expected to survive without the operation.
  4. 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

Primary outcomes:
measure: Percent Incidence of Prosthetic Complications
timeFrame: At time of study visit (anywhere from 1-8 years from prosthesis delivery)
Secondary outcomes:
measure: Percent Incidence of Biological Complications
timeFrame: At time of study visit (anywhere from 1-8 years from prosthesis delivery)
measure: Quantitative measurement of bone level
timeFrame: At time of study visit (anywhere from 1-8 years from prosthesis delivery)
measure: Patient self-reported OHIP-14 satisfaction scores
timeFrame: At time of study visit (anywhere from 1-8 years from prosthesis delivery)
measure: Patient self-reported QoLFAST-10 scores
timeFrame: At time of study visit (anywhere from 1-8 years from prosthesis delivery)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Graduate Prosthodontic Clinic, Dept. of Prosthodontics, UNC School of Dentistry
state: North Carolina
Study officials:
affiliation: UNC Associate Professor
name: Ingeborg De Kok, DDS MS
role: PRINCIPAL_INVESTIGATOR
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