Clinical trial NCT05649085: Evaluation of Single-unit Implant-supported Prostheses Survival Using CoCr Prosthetic Abutments: Prospective Observational Study
Official title: Evaluation of Single-unit Implant-supported Prostheses Survival Using CoCr Prosthetic Abutments: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Missing Teeth
Prosthesis Survival
Keywords: dental implants
dental prosthesis
Lead sponsor: Neodent
Sponsor class: INDUSTRY
First posted: 2022-12-13
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years of age who were previously subjected to the installation of GM dental implants by JJGC, at the ILAPEO College, between 2018 and 2022, who are using a healing abutment or cover screw, will receive treatment for installation of single-unit prostheses, screwed or cemented, in the maxilla or mandible, using CoCr abutments, in digital or conventional flow. Patients will be followed up and evaluated at different times over a 2-year period.

Brief summary: The aim of the study is to prospectively evaluate the survival of JJGC Cobalt-Chromium (CoCr) prosthetic abutments in single-unit implant-supported prostheses, to confirm the long-term safety and performance of the devices.

Detailed description: The cobalt-chromium prosthetic abutments are designed to be installed between the implant and prosthesis. CoCr abutment coping, CoCr abutment for crown set, block and CARES® are devices with indication for prostheses.

Data from the scientific literature support the safety and intended performance of these abutments. An observational clinical study design was chosen to augment the clinical data derived from the use of these devices in accordance with the IFU (Instruction for Use) in the daily clinical practice setting, as well as to assess the long-term prosthetic survival rate.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Patients who had GM dental implants from JJGC installed at the ILAPEO College, between 2018 and 2022
* Patients who are using a healing abutment or cover screw and are able to install single-unit, screwed or cemented prostheses, in the maxilla or mandible, which require abutments with greater transmucosal height (due to reduced interocclusal height and/or bone loss)
* Patients presenting antagonist teeth to the implant region

Exclusion Criteria:

* Patients presenting contraindications according to the IFU (instructions for use)
* Patients who require the installation of more than 3 single-unit prostheses with CoCr abutments.

Primary outcomes:
measure: Prosthesis survival arte
timeFrame: 24 months after provisional prosthesis installation
Secondary outcomes:
measure: Implant survival rate
timeFrame: 24 months after provisional prosthesis installation
measure: Implant success rate
timeFrame: 24 months after provisional prosthesis installation
measure: Patient satisfaction
timeFrame: 24 months after provisional prosthesis installation
measure: Clinician Satisfaction
timeFrame: 24 months after provisional prosthesis installation
measure: Adverse events
timeFrame: 24 months after provisional prosthesis installation
measure: Risk factors
timeFrame: 24 months after provisional prosthesis installation
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO)
Study officials:
affiliation: Neodent
name: Waleska Caldas
role: STUDY_DIRECTOR
References: