Full-arch Monolithic Zirconia ISFDP Follow up

NCT02931968 | Completed

• 1 other identifier: 16-0550
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulous

Keywords

Monolithic Zirconia; Implant supported prosthesis; Fixed partial denture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percent Incidence of Biological Complications

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

• Quantitative measurement of bone level

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

• Patient self-reported OHIP-14 satisfaction scores

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

• Patient self-reported QoLFAST-10 scores

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

Study Arms (1)

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.

Device: Monolithic zirconia prosthesis

Interventions

Monolithic zirconia prosthesis DEVICE

Edentulous arch subjects treated with a monolithic zirconia implant supported fixed dental prosthesis.

Monolithic zirconia prosthesis

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

Graduate Prosthodontic Clinic, Dept. of Prosthodontics, UNC School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (43)

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MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Ingeborg De Kok, DDS MS

  UNC Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: October 13, 2016
• Study Start: January 1, 2017
• Primary Completion: November 5, 2018
• Study Completion: November 5, 2018
• Last Updated: September 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)