Full-arch Monolithic Zirconia ISFDP Follow up

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.

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