Dental ImplantsNCT04960904
Study Evaluating the Performance and Safety in the Medium and Long Term of Global D Implant-prosthetic Systems
An observational study of Dental Implants, run by Global D at 2 sites in 2 countries.
Trial summary
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety in the medium and long term of implant-prosthetic systems including Global D dental implants: In-Kone® UNIVERSAL, In-Kone® PRIMO, twinKon®, EVL® S, EVL® K and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implants
- What is being tested?
- Dental implant surgery with implants
- Type of treatment
- Medical device
- How many people
- 514 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Nov 2019to 31 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Adult male or female patients who have had dental implant surgery. In the perspective of being able to obtain follow-up data at least 5 years and up to 10 years and the series to be continuous and exhaustive, the implantation period will be limited from * October 1, 2013 to June 30, 2015 for EVL® S, EVL® K and EVL® C, In-Kone® UNIVERSAL and In-Kone® PRIMO implants * January 1, 2013 to June 30, 2015 for twinKon® implants
Who may be able to join
- Male or female
- Major (s) at the time of the implantation
- Having needed implant surgery with one or more Global D devices:
- between October 1, 2013 - June 30, 2015 for EVL® S, EVL® K and EVL® C, In-Kone® UNIVERSAL and In-Kone® PRIMO implants
- between January 1, 2013 - June 30, 2015 for twinKon® implants
- Affiliated or benefiting from French Social Security
- Not opposing the use of their data
- Having carried out his annual follow-up visit at 5, 7/8 and 10 years or any other visit motivated by the removal of the implant during the 10 years
Who cannot join
- Patient unable to understand information related to his/her participation in the study
- Deceased patient, date of death after the date of implantation
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
About this study
Official title: Study Evaluating the Performance and Safety in the Medium and Long Term of Implant-prosthetic Systems Including Ranges of Dental Implants and Prosthetic Components Global D: In-Kone® U,In-Kone® P,twinKon®,EVL® S,EVL® K,EVL® C
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety in the medium and long term of implant-prosthetic systems including Global D dental implants: In-Kone® UNIVERSAL, In-Kone® PRIMO, twinKon®, EVL® S, EVL® K and EVL® C.
Read the detailed description
Study design: Ambispective multi-center observational study, on a single patient group per implant, constituting a consecutive and exhaustive series of subjects, without selection.
Investigators:Twelve centers participated to the study in France and one in Greece.
The objectives are evaluate the 5-year follow-up performance and safety of Global D dental implant ranges, which consist of collecting data at a 5-year follow-up visit (prospectively or retrospectively). All previous data is collected retrospectively from the patient's file. The study has been extended to 7/8 years and up to 10 years follow-up.
- Conditions
- Dental Implants
- Being tested
- Dental implant surgery with implants
- Keywords
- dental implant, survival rate, performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant surgery with implantsDevice
Adult patients who have had dental implant surgery.
| Study group | Role | What they receive |
|---|---|---|
| In-Kone® UNIVERSAL | Implant-prosthetic systems made with dental implants and prosthetic components of the ranges In-Kone® UNIVERSAL, including the former 3.0 range now named In-Kone® Universal NR (narrow), and including the In-Kone® Universal WD (wide). Receives: Device: Dental implant surgery with implants | |
| In-Kone® PRIMO | Implant-prosthetic systems made with dental implants and prosthetic components of the ranges In-Kone® PRIMO Receives: Device: Dental implant surgery with implants | |
| twinKon® | Implant-prosthetic systems made with dental implants and prosthetic components of the ranges twinKon® Receives: Device: Dental implant surgery with implants | |
| EVL® S | Implant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® S Receives: Device: Dental implant surgery with implants | |
| EVL® K | Implant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® K Receives: Device: Dental implant surgery with implants | |
| EVL® C | Implant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® C Receives: Device: Dental implant surgery with implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Survival rate at 5 years, 7/8 years and 10 years minimum defined by the rate of implants in situ
Measured: 5 years
Secondary outcomes (5)
Implant system stability
Implant system stability of all follow-up visits. Stability of the implant system is assessed by the investigator at each visit. The variable collected is YES for stable implant and NO for unstable implant.
Measured: 1-4 month, 6-12 month, 5 years, 7/8 years and 10 years after surgery
The success rate
The success rate at 5 years, 7/8 years and 10 years defined by the rate of stable implants without pain or sensitivity at the implant level, with the absence of peri-implantitis and osteolysis;
Measured: 5 years, 7/8 years, 10 years
Appearance of the gum
Appearance of the gum based on the visual appearance of the gum will be collected. Several choices are possible: Inflammation / Gingival recession / Absence of keratinized tissue band around the crown
Measured: 5 years, 7/8 years, 10 years
Adverse events and complications
Nature, number, severity and degree of relationship of adverse events, serious or not, reported as implant-related or unrelated for non-serious adverse events, immediate or delayed at all visits
Measured: Up to 5 years, 7/8 years, and 10 years of follow-up
Score of Quality of life (OHIP-14 - The Oral Health Impact Profile)
The score obtained from the satisfaction and quality of life questionnaire (OHIP-14) at 5 years The Oral Health Impact Profile 14 (OHIP-14) [14] is a questionnaire measuring the impact of the prosthetic restoration on the patient's well-being and quality of life. The patient answers fourteen questions grouped into seven domains (functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap) . For each question, the patient can answer with one of the following values: never:0, almost never:1, occasionally:2, quite often:3, very often:4. The sum of the values for each question gives a score that can vary from 0 to 56. A high score reflects a high level of discomfort.
Measured: 5 years, 7/8 years, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start12 Nov 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- Other
- Enrolment
- 514 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Global D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean Pierre AXIOTIS, MD, Principal investigator, Dental surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960904
- Sponsor's protocol ID
- 1905-G-IMP-DENT-R
- Status last verified
- Mar 2025
- First submitted
- 30 Jun 2021
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating the Performance and Safety in the Medium and Long Term of Implant-prosthetic Systems Including Ranges of Dental Implants and Prosthetic Components Global D: In-Kone® U,In-Kone® P,twinKon®,EVL® S,EVL® K,EVL® C
- ClinicalTrials.gov ID
- NCT04960904
- Acronym / sponsor ID
- 1905-G-IMP-DENT-R
- Conditions
- Dental Implants
- Keywords
- dental implant, survival rate, performance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 514 participants (estimated)
- Lead sponsor
- Global DIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 14 Jul 2021 (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.
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety in the medium and long term of implant-prosthetic systems including Global D dental implants: In-Kone® UNIVERSAL, In-Kone® PRIMO, twinKon®, EVL® S, EVL® K and EVL® C.
Detailed description
Study design: Ambispective multi-center observational study, on a single patient group per implant, constituting a consecutive and exhaustive series of subjects, without selection.
Investigators:Twelve centers participated to the study in France and one in Greece.
The objectives are evaluate the 5-year follow-up performance and safety of Global D dental implant ranges, which consist of collecting data at a 5-year follow-up visit (prospectively or retrospectively). All previous data is collected retrospectively from the patient's file. The study has been extended to 7/8 years and up to 10 years follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| In-Kone® UNIVERSAL | – | Device: Dental implant surgery with implantsImplant-prosthetic systems made with dental implants and prosthetic components of the ranges In-Kone® UNIVERSAL, including the former 3.0 range now named In-Kone® Universal NR (narrow), and including the In-Kone® Universal WD (wide). |
| In-Kone® PRIMO | – | Device: Dental implant surgery with implantsImplant-prosthetic systems made with dental implants and prosthetic components of the ranges In-Kone® PRIMO |
| twinKon® | – | Device: Dental implant surgery with implantsImplant-prosthetic systems made with dental implants and prosthetic components of the ranges twinKon® |
| EVL® S | – | Device: Dental implant surgery with implantsImplant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® S |
| EVL® K | – | Device: Dental implant surgery with implantsImplant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® K |
| EVL® C | – | Device: Dental implant surgery with implantsImplant-prosthetic systems made with dental implants and prosthetic components of the ranges EVL® C |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male or female patients who have had dental implant surgery. In the perspective of being able to obtain follow-up data at least 5 years and up to 10 years and the series to be continuous and exhaustive, the implantation period will be limited from * October 1, 2013 to June 30, 2015 for EVL® S, EVL® K and EVL® C, In-Kone® UNIVERSAL and In-Kone® PRIMO implants * January 1, 2013 to June 30, 2015 for twinKon® implants
Key inclusion criteria (8 listed)
- Male or female
- Major (s) at the time of the implantation
- Having needed implant surgery with one or more Global D devices:
- between October 1, 2013 - June 30, 2015 for EVL® S, EVL® K and EVL® C, In-Kone® UNIVERSAL and In-Kone® PRIMO implants
- between January 1, 2013 - June 30, 2015 for twinKon® implants
Key exclusion criteria (2 listed)
- Patient unable to understand information related to his/her participation in the study
- Deceased patient, date of death after the date of implantation
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 |
|---|---|---|
| Dental implant surgery with implantsAdult patients who have had dental implant surgery. | Device | EVL® C, EVL® K, EVL® S, In-Kone® PRIMO, In-Kone® UNIVERSAL, twinKon® |
Primary outcome
Survival rate
Time frame: 5 years
Survival rate at 5 years, 7/8 years and 10 years minimum defined by the rate of implants in situ
5 secondary outcomes
Implant system stability
Time frame: 1-4 month, 6-12 month, 5 years, 7/8 years and 10 years after surgery
The success rate
Time frame: 5 years, 7/8 years, 10 years
Appearance of the gum
Time frame: 5 years, 7/8 years, 10 years
Adverse events and complications
Time frame: Up to 5 years, 7/8 years, and 10 years of follow-up
Score of Quality of life (OHIP-14 - The Oral Health Impact Profile)
Time frame: 5 years, 7/8 years, 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- 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.
Jean Pierre AXIOTIS, MD principal investigator
Dental surgeon
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implants, run by Global D at 2 sites in 2 countries.
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 8 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: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Greece. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathalie TRETOUT (0478569700, n.tretout@globald.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: 5 years). 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 2 Apr 2025.