Endosseous Dental Implant Failure Clinical Trial
Official title:
Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior
NCT number | NCT01974362 |
Other study ID # | II-06 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 2014 |
Est. completion date | August 1, 2024 |
Verified date | December 2022 |
Source | Implantology Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In patients that did a full mouth implant supported rehabilitation does Cad/Cam Monolithic Zirconia compared to Cad/Cam Zirconia Suprastructure (zirconium oxide (Yttrium - partially stabilized with tetragonal polycrystalline structure) veneered with feldspathic ceramic, has less post-insertion complications after at least 1-Year follow-up ?
Status | Recruiting |
Enrollment | 90 |
Est. completion date | August 1, 2024 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Maxilla and/or Mandible Implant full-mouth restoration - Monolithic ceramic or zirconia-feldspathic restoration - be at least 18 years of age; - present no systemic or local absolute contraindications for endosseous implant placement; - at least 1 Year Follow-up Exclusion Criteria: - the presence of any systemic disease or condition that could compromise postoperative healing or osseointegration. - Not full mouth rehabilitation |
Country | Name | City | State |
---|---|---|---|
Portugal | Artur Simões | Lisboa |
Lead Sponsor | Collaborator |
---|---|
Implantology Institute |
Portugal,
Carames J, Marques D, Malta Barbosa J, Moreira A, Crispim P, Chen A. Full-arch implant-supported rehabilitations: A prospective study comparing porcelain-veneered zirconia frameworks to monolithic zirconia. Clin Oral Implants Res. 2019 Jan;30(1):68-78. do — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Amount of Chipping | measure the total number of ceramic fractures (chipping) visible at naked eye in both groups (monolithic and feldspathic) that happen from insertion (baseline) to last follow-up visit
Primary outcomes are defined as survival and success rates of the final prosthesis. For evaluation of these outcomes, an analysis variable will be used (Mendez Caramês et al., 2016): if no alterations are present, the prosthesis will be recorded as "Alpha" |
at least 1-Year post-insertion | |
Primary | Number of Small Complications | Measure the total amount of adverse events other than chipping, that made the patient come to the dental office, that happen from insertion (baseline) to last follow up visit
It is determined that if the complication was solved in the dental chair is considered a Small complication/minor chipping - not requiring any intervention besides polishing or recontouring without the need for prosthesis retrieval-"Bravo" classification will be attributed |
at least 1-year post-insertion | |
Primary | Number of Big Complications | Measure the total amount of adverse events other than chipping, that made the patient come to the dental office, that happen from insertion (baseline) to last follow up.
It is determined that if the complication was solved in the dental laboratory is considered a big complication/major chipping - a "Charlie" classification will indicate the occurrence of major chipping, need for prosthesis retrieval and laboratory intervention; |
at least 1-Year post Insertion | |
Primary | Number of prosthesis failures | a "Delta" classification will be attributed when fracture of the framework is present, defining a non-surviving prosthesis | at least 1-year post insertion | |
Secondary | Biological complications | implant success rates will be evaluated; absence of persistent subjective complaints (pain, foreign body sensation, and/ or dysesthesia); absence of peri-implant infection with suppuration; absence of implant mobility; and absence of continuous radiolucency around the implant by previously established methods based on the clinical and radiographic examinations at the yearly visits | at least 1-Year post insertion |
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