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Full-arch Monolithic Zirconia ISFDP Follow up

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ClinicalTrials.gov Identifier: NCT02931968
Recruitment Status : Active, not recruiting
First Posted : October 13, 2016
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment
Edentulous Device: Monolithic zirconia prosthesis

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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Clinical Study Evaluating Full-Arch Monolithic Zirconia Implant Supported Fixed Dental Prosthesis
Actual Study Start Date : January 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs
Drug Information available for: Zirconium

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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931968


Locations
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United States, North Carolina
Graduate Prosthodontic Clinic, Dept. of Prosthodontics, UNC School of Dentistry
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Ingeborg De Kok, DDS MS UNC Associate Professor

Publications:

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02931968     History of Changes
Other Study ID Numbers: 16-0550
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:
Monolithic Zirconia
Implant supported prosthesis
Fixed partial denture

Additional relevant MeSH terms:
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Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases