Evaluation of Single-unit Implant-supported Prostheses Survival Using CoCr Prosthetic Abutments: Prospective Observational Study

NCT05649085 | Unknown FDA Device

• 1 other identifier: CS.O.013
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Missing Teeth; Prosthesis Survival

Keywords

dental implants; dental prosthesis

Outcome Measures

Primary Outcomes (1)

• Prosthesis survival arte

  Evaluation of the survival rate of implant-supported prostheses using CoCr prosthetic abutments.

  24 months after provisional prosthesis installation

Secondary Outcomes (6)

• Implant survival rate

  24 months after provisional prosthesis installation

• Implant success rate

  24 months after provisional prosthesis installation

• Patient satisfaction

  24 months after provisional prosthesis installation

• Clinician Satisfaction

  24 months after provisional prosthesis installation

• Adverse events

  24 months after provisional prosthesis installation

Interventions

Cobalt-Chromium (CoCr) prosthetic abutments DEVICE

Cobalt-Chromium (CoCr) prosthetic abutments in single-unit implant-supported prostheses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neodent: lead

Study Sites (1)

Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO)

Curitiba, Brazil

RECRUITING

MeSH Terms

Conditions

Anodontia; Prosthesis Failure

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Waleska Caldas

  Neodent

  STUDY DIRECTOR

Central Study Contacts

Andrew Melenikiotis, MSc

CONTACT

+55 41 3595-6000; amelenikiotis@uol.com.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 13, 2022
• Study Start: November 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: November 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)