Full-arch Monolithic Zirconia ISFDP Follow up

September 21, 2020 updated by: University of North Carolina, Chapel Hill

A Retrospective Clinical Study Evaluating Full-Arch Monolithic Zirconia Implant Supported Fixed Dental Prosthesis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Graduate Prosthodontic Clinic, Dept. of Prosthodontics, UNC School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Edentulous arch subjects treated with a monolithic zirconia implant supported fixed dental prosthesis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Incidence of Prosthetic Complications
Time Frame: 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)
At time of study visit (anywhere from 1-8 years from prosthesis delivery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Incidence of Biological Complications
Time Frame: 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
At time of study visit (anywhere from 1-8 years from prosthesis delivery)
Quantitative measurement of bone level
Time Frame: 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.
At time of study visit (anywhere from 1-8 years from prosthesis delivery)
Patient self-reported OHIP-14 satisfaction scores
Time Frame: 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.
At time of study visit (anywhere from 1-8 years from prosthesis delivery)
Patient self-reported QoLFAST-10 scores
Time Frame: 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.
At time of study visit (anywhere from 1-8 years from prosthesis delivery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Ingeborg De Kok, DDS MS, UNC Associate Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

November 5, 2018

Study Completion (Actual)

November 5, 2018

Study Registration Dates

First Submitted

October 11, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (Estimate)

October 13, 2016

Study Record Updates

Last Update Posted (Actual)

September 23, 2020

Last Update Submitted That Met QC Criteria

September 21, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-0550

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Edentulous

Clinical Trials on Monolithic zirconia prosthesis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe