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EdentulousNCT02931968

Full-arch Monolithic Zirconia ISFDP Follow up

An observational study of Edentulous, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Edentulous
What is being tested?
Monolithic zirconia prosthesis
Type of treatment
Medical device
How many people
22 participants
Where
1 siteUnited States
Study dates
Jan 2017to 5 Nov 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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
  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Edentulous
Being tested
Monolithic zirconia prosthesis
Keywords
Monolithic Zirconia, Implant supported prosthesis, Fixed partial denture
Medical subject headings
Mouth, Edentulous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Monolithic zirconia prosthesisDevice

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

Study groups in NCT02931968
Study groupRoleWhat they receive
Monolithic zirconia prosthesisSubjects 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.
Receives: Device: Monolithic zirconia prosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (4)

  1. Percent Incidence of Biological Complications

    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

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

  2. Quantitative measurement of bone level

    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.

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

  3. Patient self-reported OHIP-14 satisfaction scores

    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.

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

  4. Patient self-reported QoLFAST-10 scores

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2016 (estimated)
  2. Study startJan 2017
  3. Primary completion5 Nov 2018
  4. Study completion5 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02931968
Sponsor's protocol ID
16-0550
Status last verified
Sep 2020
First submitted
11 Oct 2016
Last updated
23 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Abdulmajeed AA, Lim KG, Narhi TO, Cooper LF. Complete-arch implant-supported monolithic zirconia fixed dental prostheses: A systematic review. J Prosthet Dent. 2016 Jun;115(6):672-677.e1. doi: 10.1016/j.prosdent.2015.08.025. Epub 2016 Jan 23.

    PubMed 26809220

  • Al-Amleh B, Lyons K, Swain M. Clinical trials in zirconia: a systematic review. J Oral Rehabil. 2010 Aug;37(8):641-52. doi: 10.1111/j.1365-2842.2010.02094.x. Epub 2010 Apr 9.

    PubMed 20406352

  • Allen F, McMillan A. Food selection and perceptions of chewing ability following provision of implant and conventional prostheses in complete denture wearers. Clin Oral Implants Res. 2002 Jun;13(3):320-6. doi: 10.1034/j.1600-0501.2002.130313.x.

    PubMed 12010164

  • Attard NJ, Zarb GA. Long-term treatment outcomes in edentulous patients with implant-fixed prostheses: the Toronto study. Int J Prosthodont. 2004 Jul-Aug;17(4):417-24.

    PubMed 15382777

  • Balshi TJ, Wolfinger GJ, Slauch RW, Balshi SF. A retrospective analysis of 800 Branemark System implants following the All-on-Four protocol. J Prosthodont. 2014 Feb;23(2):83-8. doi: 10.1111/jopr.12089. Epub 2013 Jul 25.

    PubMed 23890014

  • Bozini T, Petridis H, Garefis K, Garefis P. A meta-analysis of prosthodontic complication rates of implant-supported fixed dental prostheses in edentulous patients after an observation period of at least 5 years. Int J Oral Maxillofac Implants. 2011 Mar-Apr;26(2):304-18.

    PubMed 21483883

  • Carames J, Tovar Suinaga L, Yu YC, Perez A, Kang M. Clinical Advantages and Limitations of Monolithic Zirconia Restorations Full Arch Implant Supported Reconstruction: Case Series. Int J Dent. 2015;2015:392496. doi: 10.1155/2015/392496. Epub 2015 Jun 1.

    PubMed 26124835

  • Cheng CW, Chien CH, Chen CJ, Papaspyridakos P. Complete-mouth implant rehabilitation with modified monolithic zirconia implant-supported fixed dental prostheses and an immediate-loading protocol: a clinical report. J Prosthet Dent. 2013 Jun;109(6):347-52. doi: 10.1016/S0022-3913(13)00109-1. No abstract available.

    PubMed 23763777

  • Cooper LF. The current and future treatment of edentulism. J Prosthodont. 2009 Feb;18(2):116-22. doi: 10.1111/j.1532-849X.2009.00441.x.

    PubMed 19254301

  • Davis DM, Packer ME, Watson RM. Maintenance requirements of implant-supported fixed prostheses opposed by implant-supported fixed prostheses, natural teeth, or complete dentures: a 5-year retrospective study. Int J Prosthodont. 2003 Sep-Oct;16(5):521-3.

    PubMed 14651238

  • de Avila ED, Avila-Campos MJ, Vergani CE, Spolidorio DM, Mollo Fde A Jr. Structural and quantitative analysis of a mature anaerobic biofilm on different implant abutment surfaces. J Prosthet Dent. 2016 Apr;115(4):428-36. doi: 10.1016/j.prosdent.2015.09.016. Epub 2015 Nov 17.

    PubMed 26597465

  • Douglass CW, Shih A, Ostry L. Will there be a need for complete dentures in the United States in 2020? J Prosthet Dent. 2002 Jan;87(1):5-8. doi: 10.1067/mpr.2002.121203.

    PubMed 11807476

  • Ekelund JA, Lindquist LW, Carlsson GE, Jemt T. Implant treatment in the edentulous mandible: a prospective study on Branemark system implants over more than 20 years. Int J Prosthodont. 2003 Nov-Dec;16(6):602-8.

    PubMed 14714838

  • Felton DA. Edentulism and comorbid factors. Tex Dent J. 2010 Apr;127(4):389-401.

    PubMed 20446489

  • Fueki K, Kimoto K, Ogawa T, Garrett NR. Effect of implant-supported or retained dentures on masticatory performance: a systematic review. J Prosthet Dent. 2007 Dec;98(6):470-7. doi: 10.1016/S0022-3913(07)60147-4.

    PubMed 18061741

Questions about this trial

What is this clinical trial studying?

An observational study of Edentulous, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Incidence of Prosthetic Complications (time frame: At time of study visit (anywhere from 1-8 years from prosthesis delivery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02931968, which also lists 43 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020.

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