CompletedNot Applicable

Full-arch Monolithic Zirconia ISFDP Follow up

United States22 participantsStarted 2017-01

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. ASA I - A normal healthy patient
✓. ASA II - A patient with mild systemic health.
✓. 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

✕. 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.

What they're measuring

Percent Incidence of Prosthetic Complications

Timeframe: At time of study visit (anywhere from 1-8 years from prosthesis delivery)

Trial details

NCT IDNCT02931968

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-11-05

View on ClinicalTrials.gov More Edentulous trials