Missing TeethNCT05649085
Evaluation of Single-unit Implant-supported Prostheses Survival Using CoCr Prosthetic Abutments: Prospective Observational Study
An observational study of Missing Teeth and Prosthesis Survival, run by Neodent at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth, Prosthesis Survival
- What is being tested?
- Cobalt-Chromium (CoCr) prosthetic abutments
- Type of treatment
- Medical device
- How many people
- 167 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2023to Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO)
Curitiba
Andrew Sotirios Melenekiotis, amelenikiotis@gmail.com
About this study
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.
Read the 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.
- Conditions
- Missing Teeth, Prosthesis Survival
- Being tested
- Cobalt-Chromium (CoCr) prosthetic abutments
- Keywords
- dental implants, dental prosthesis
- Medical subject headings
- Anodontia, Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cobalt-Chromium (CoCr) prosthetic abutmentsDevice
Cobalt-Chromium (CoCr) prosthetic abutments in single-unit implant-supported prostheses
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthesis survival arte
Evaluation of the survival rate of implant-supported prostheses using CoCr prosthetic abutments.
Measured: 24 months after provisional prosthesis installation
Secondary outcomes (6)
Implant survival rate
Survival rate of implant rehabilitated with prosthesis using CoCr abutments
Measured: 24 months after provisional prosthesis installation
Implant success rate
Success rate of implant rehabilitated with prosthesis using CoCr abutments
Measured: 24 months after provisional prosthesis installation
Patient satisfaction
Patient satisfaction with the treatment
Measured: 24 months after provisional prosthesis installation
Clinician Satisfaction
Surgeon satisfaction after the installation of the prosthesis regarding the devices used
Measured: 24 months after provisional prosthesis installation
Adverse events
- Occurrence of adverse events, device deficiencies and residual risks related to abutments, prostheses, and oral health.
Measured: 24 months after provisional prosthesis installation
Risk factors
Influence of risk factors on observed results
Measured: 24 months after provisional prosthesis installation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study startNov 2023 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missing TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neodent
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Waleska Caldas, Study director, Neodent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649085
- Sponsor's protocol ID
- CS.O.013
- Status last verified
- Feb 2023
- First submitted
- 5 Dec 2022
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Single-unit Implant-supported Prostheses Survival Using CoCr Prosthetic Abutments: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05649085
- Acronym / sponsor ID
- CS.O.013
- Conditions
- Missing Teeth, Prosthesis Survival
- Keywords
- dental implants, dental prosthesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 167 participants (estimated)
- Lead sponsor
- NeodentIndustry (pharma, biotech, devices)
- Study start
- Nov 2023 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cobalt-Chromium (CoCr) prosthetic abutmentsCobalt-Chromium (CoCr) prosthetic abutments in single-unit implant-supported prostheses | Device | – |
Primary outcome
Prosthesis survival arte
Time frame: 24 months after provisional prosthesis installation
Evaluation of the survival rate of implant-supported prostheses using CoCr prosthetic abutments.
6 secondary outcomes
Implant survival rate
Time frame: 24 months after provisional prosthesis installation
Implant success rate
Time frame: 24 months after provisional prosthesis installation
Patient satisfaction
Time frame: 24 months after provisional prosthesis installation
Clinician Satisfaction
Time frame: 24 months after provisional prosthesis installation
Adverse events
Time frame: 24 months after provisional prosthesis installation
Risk factors
Time frame: 24 months after provisional prosthesis installation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waleska Caldas study director
Neodent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Missing Teeth and Prosthesis Survival, run by Neodent at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Melenikiotis, MSc (+55 41 3595-6000, amelenikiotis@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthesis survival arte (time frame: 24 months after provisional prosthesis installation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.