Full-arch Monolithic Zirconia ISFDP Follow up

Edentulous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02931968
• Other study ID #: 16-0550
• Status: Completed
• Start date: January 2017
• Est. completion date: November 5, 2018

Study information

• Verified date: September 2020
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 5, 2018
• Est. primary completion date: November 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Edentulous
• Mouth, Edentulous

Intervention

Device:
• Monolithic zirconia prosthesis
Edentulous arch subjects treated with a monolithic zirconia implant supported fixed dental prosthesis.

Locations

Country	Name	City	State
United States	Graduate Prosthodontic Clinic, Dept. of Prosthodontics, UNC School of Dentistry	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (43)

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* Note: There are 43 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	At time of study visit (anywhere from 1-8 years from prosthesis delivery)
Secondary	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.	At time of study visit (anywhere from 1-8 years from prosthesis delivery)
Secondary	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.	At time of study visit (anywhere from 1-8 years from prosthesis delivery)
Secondary	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.	At time of study visit (anywhere from 1-8 years from prosthesis delivery)