Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
22 participants
Study Classification
OBSERVATIONAL
Study Start Date
2017-01-31
Study Completion Date
2018-11-05
Brief Summary
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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.
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Detailed Description
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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.
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
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Edentulous
Study Design
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Observational Model Type
COHORT
Study Time Perspective
RETROSPECTIVE
Study Groups
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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.
Monolithic zirconia prosthesis
Intervention Type
DEVICE
Edentulous arch subjects treated with a monolithic zirconia implant supported fixed dental prosthesis.
Interventions
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Monolithic zirconia prosthesis
Edentulous arch subjects treated with a monolithic zirconia implant supported fixed dental prosthesis.
Intervention Type
DEVICE
Eligibility Criteria
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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.
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
99 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Ingeborg De Kok, DDS MS
Role: PRINCIPAL_INVESTIGATOR
UNC Associate Professor
Locations
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Graduate Prosthodontic Clinic, Dept. of Prosthodontics, UNC School of Dentistry
Chapel Hill, North Carolina, United States
Site Status
Countries
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United States
References
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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.
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Jemt T, Johansson J. Implant treatment in the edentulous maxillae: a 15-year follow-up study on 76 consecutive patients provided with fixed prostheses. Clin Implant Dent Relat Res. 2006;8(2):61-9. doi: 10.1111/j.1708-8208.2006.00003.x.
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Kwon T, Bain PA, Levin L. Systematic review of short- (5-10 years) and long-term (10 years or more) survival and success of full-arch fixed dental hybrid prostheses and supporting implants. J Dent. 2014 Oct;42(10):1228-41. doi: 10.1016/j.jdent.2014.05.016. Epub 2014 Jun 26.
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Limmer B, Sanders AE, Reside G, Cooper LF. Complications and patient-centered outcomes with an implant-supported monolithic zirconia fixed dental prosthesis: 1 year results. J Prosthodont. 2014 Jun;23(4):267-75. doi: 10.1111/jopr.12110. Epub 2014 Jan 6.
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Mertens C, Steveling HG. Early and immediate loading of titanium implants with fluoride-modified surfaces: results of 5-year prospective study. Clin Oral Implants Res. 2011 Dec;22(12):1354-60. doi: 10.1111/j.1600-0501.2010.02123.x. Epub 2011 Mar 8.
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Papaspyridakos P, Lal K. Immediate loading of the maxilla with prefabricated interim prosthesis using interactive planning software, and CAD/CAM rehabilitation with definitive zirconia prosthesis: 2-year clinical follow-up. J Esthet Restor Dent. 2010 Aug;22(4):223-32. doi: 10.1111/j.1708-8240.2010.00343.x.
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Pozzi A, Holst S, Fabbri G, Tallarico M. Clinical reliability of CAD/CAM cross-arch zirconia bridges on immediately loaded implants placed with computer-assisted/template-guided surgery: a retrospective study with a follow-up between 3 and 5 years. Clin Implant Dent Relat Res. 2015 Jan;17 Suppl 1:e86-96. doi: 10.1111/cid.12132. Epub 2013 Aug 5.
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Purcell BA, McGlumphy EA, Holloway JA, Beck FM. Prosthetic complications in mandibular metal-resin implant-fixed complete dental prostheses: a 5- to 9-year analysis. Int J Oral Maxillofac Implants. 2008 Sep-Oct;23(5):847-57.
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Rimondini L, Cerroni L, Carrassi A, Torricelli P. Bacterial colonization of zirconia ceramic surfaces: an in vitro and in vivo study. Int J Oral Maxillofac Implants. 2002 Nov-Dec;17(6):793-8.
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Rojas-Vizcaya F. Full zirconia fixed detachable implant-retained restorations manufactured from monolithic zirconia: clinical report after two years in service. J Prosthodont. 2011 Oct;20(7):570-6. doi: 10.1111/j.1532-849X.2011.00784.x.
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Slade GD, Akinkugbe AA, Sanders AE. Projections of U.S. Edentulism prevalence following 5 decades of decline. J Dent Res. 2014 Oct;93(10):959-65. doi: 10.1177/0022034514546165. Epub 2014 Aug 21.
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Thalji GN, Cooper LF. Implant-supported fixed dental rehabilitation with monolithic zirconia: a clinical case report. J Esthet Restor Dent. 2014 Mar-Apr;26(2):88-96. doi: 10.1111/jerd.12078. Epub 2014 Jan 2.
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Turkyilmaz I, Company AM, McGlumphy EA. Should edentulous patients be constrained to removable complete dentures? The use of dental implants to improve the quality of life for edentulous patients. Gerodontology. 2010 Mar;27(1):3-10. doi: 10.1111/j.1741-2358.2009.00294.x. Epub 2009 Mar 8.
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Venezia P, Torsello F, Cavalcanti R, D'Amato S. Retrospective analysis of 26 complete-arch implant-supported monolithic zirconia prostheses with feldspathic porcelain veneering limited to the facial surface. J Prosthet Dent. 2015 Oct;114(4):506-12. doi: 10.1016/j.prosdent.2015.02.010. Epub 2015 Jun 5.
Reference Type
BACKGROUND
Other Identifiers
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16-0550
Identifier Type: -
Identifier Source: org_study_id
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