Edentulous MouthNCT05375045
Real-life Evaluation of the Safety and Performance of EUROTEKNIKA Dental Implants
An observational study of Edentulous Mouth, run by Euroteknika at 1 site in France.
Trial summary
Real-life evaluation of the safety and performance of EUROTEKNIKA dental implants Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulous Mouth
- What is being tested?
- dental implantation
- Type of treatment
- Medical device
- How many people
- 868 participants
- Where
- 1 siteFrance
- Study dates
- 25 Mar 2022to 1 Feb 2028
- 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: Patients who received one or more EUROTEKNIKA implants before 2017 may be included in the study for the retrospective cohort for Naturactis, Naturall+, Aesthetica+2, ORIGIN, iBone E, iBone S and iBone G implants. These patients will be included consecutively in chronological order to avoid selection bias. A prospective cohort will also be recruited in the study, in order to meet the secondary objective concerning the improvement of the quality of life. In fact, to measure the improvement in quality of life, a questionnaire must be completed by the patient before the implant is placed. Answers to this questionnaire preoperatively cannot be collected for patients recruited retrospectively.
Who may be able to join
- Patient aged 18 or over
- Patient who has completed bone growth
- Patient informed and agreeing to participate in the study
- Partially or totally edentulous patient who will be implanted with the EUROTEKNIKA dental implant (for the prospective cohort)
- Patient to benefit from the placement of an implant for the creation of a single crown (for the prospective cohort)
- Patient implanted with the EUROTEKNIKA dental implant before 2017 (for the retrospective cohort)
- Patient having benefited from the placement of an implant for the creation of a single crown (for the retrospective cohort)
Who cannot join
- Pregnant or breastfeeding women (for the prospective cohort)
- Patient with bone disease in the cervico-facial region
- Patient refusing to participate in the study
- Patient with at least one contraindication to implantation (for the prospective cohort)
- Patient to benefit from the placement of an implant with immediate or early loading (for the prospective cohort)
- Patient to benefit from the placement of an implant for the support of the bridge, piles, attachment (for the prospective cohort)
- Patient having benefited from the placement of an implant with immediate or early loading (for the retrospective cohort)
- Patient having benefited from the placement of an implant for the support of the bridge, piles, attachment (for the retrospective cohort)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Clermont Ferrand
Clermont-Ferrand, 63003
Christophe DESCHAUMES, Pr, 06 81 12 42 07 ext. +033, christophe.deschaumes@ucal.fr
About this study
Real-life evaluation of the safety and performance of EUROTEKNIKA dental implants
Read the detailed description
Many adults have one or more missing teeth. The negative consequences of partial or total edentulousness are numerous at the level of the orofacial sphere :
- Edentulism generates a strong aesthetic deficit due to the lack of support of the tissues and the facial musculature;
- Edentulism causes a functional deficit that can have significant repercussions on the nutritional status of the affected subject;
- Edentulism is accompanied by bone resorption of the jaws which is unavoidable in the absence of implant treatment;
- In addition, the resulting feelings of discomfort and fragility are experienced as a real psychological handicap by the patient, partially or totally edentulous, which can then have significant repercussions on his social life.
EUROTEKNIKA dental implants are intended to be used for the replacement of a dental root in order to support a fixed or mobile prosthesis and thus restore masticatory function. EUROTEKNIKA dental implants are made of titanium or titanium alloy for surgical implants in accordance with ISO5832-2 and -3 standards.
EUROTEKNIKA dental implants are intended for use in cases of single, partial or complete edentulism on the maxillary and/or mandibular arch:
- Single tooth loss,
- Intercalary toothlessness,
- Terminal toothlessness,
- Total edentulism.
Dental implantology is based on the following principle: an implant is surgically inserted into the maxilla or mandible, and then a pillar is connected to this implant to support the dental prosthesis.
The use of dental implants is based on a biological process called osseointegration. Osseointegration corresponding to the fact that certain materials such as titanium are able to form direct contact with the surrounding bone. Osseointegration is therefore the direct structural and functional connection between living bone and the surface of an artificial implant. In order to allow the osseointegration process, and depending on the clinical case, a more or less long healing period must be observed before connecting the prosthetic elements to the implant. In cases of immediate loading, there is no healing period.
The expected benefits of this surgery are to improve the quality of life of patients and to recover masticatory function.
The claimed clinical performances are:
- High primary stability,
- High long-term implant stability,
- Limitation of bone resorption and risks of mucositis and peri-implantitis
- Maintenance of soft tissues.
The objectives of this study are therefore to assess the safety and performance of EUROTEKNIKA dental implants.
- Conditions
- Edentulous Mouth
- Being tested
- dental implantation
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implantationDevice
an implant is surgically inserted into the maxilla or mandible, and then an abutment is connected to this implant to support the dental prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| prospective | A prospective cohort will be recruited into the study to meet the secondary objective of improving quality of life. In fact, to measure the improvement in quality of life, a questionnaire must be completed by the patient before the implant is placed. Answers to this questionnaire preoperatively cannot be collected for patients recruited retrospectively. Receives: Device: dental implantation | |
| retrospective | Patients who received one or more EUROTEKNIKA implants before 2017 may be included in the study for the retrospective cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of tissue integration of the implant
Integration of the implant 5 years after implantation
Measured: 5 years after implantation
Secondary outcomes (7)
assessment of the quality of life of patients following the recovery of full dentition with the GOHAI score (General Oral Health Assessment Index)
the quality of life of patients will be evaluated with the GOHAI score before implantation and 5 years after implantation
Measured: 5 years after implantation
Complication rate taking into account pain, local tenderness, infection, mobility of the implant, fracture
pain, local tenderness, infection, mobility of the implant, fracture will be collected during the 5 years follow-up
Measured: 5 years after implantation
measuring chewing function after prosthesis placement
Occlusal assessment will be performed after implantation and at 5 years follow-up
Measured: 5 years after implantation
Rate of inflammation (visual)
Assessment of inflammation with visual examination 5 years after implantation
Measured: 5 years after implantation
Assessment of the evolution of the péri-implant tissues
assessment of the evolution of the péri-implant tissues with the Pink esthetic score
Measured: 5 years after implantation
assessment of the osseointegration of the implant
assessment of the osseointegration of the implant with the ISQ score
Measured: 5 years after implantation
Rate of infection (x-ray)
Assessment of infection with radiographic examination 5 years after implantation
Measured: 5 years after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start25 Mar 2022
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous MouthStudies 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
- 868 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Euroteknika
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375045
- Sponsor's protocol ID
- SUIVI IMPLANTS
- Status last verified
- May 2022
- First submitted
- 3 Mar 2022
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Evaluation of the Safety and Performance of EUROTEKNIKA Dental Implants
- ClinicalTrials.gov ID
- NCT05375045
- Acronym / sponsor ID
- SUIVI IMPLANTS
- Conditions
- Edentulous Mouth
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 868 participants (estimated)
- Lead sponsor
- EuroteknikaIndustry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 16 May 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.
Real-life evaluation of the safety and performance of EUROTEKNIKA dental implants
Detailed description
Many adults have one or more missing teeth. The negative consequences of partial or total edentulousness are numerous at the level of the orofacial sphere :
- Edentulism generates a strong aesthetic deficit due to the lack of support of the tissues and the facial musculature;
- Edentulism causes a functional deficit that can have significant repercussions on the nutritional status of the affected subject;
- Edentulism is accompanied by bone resorption of the jaws which is unavoidable in the absence of implant treatment;
- In addition, the resulting feelings of discomfort and fragility are experienced as a real psychological handicap by the patient, partially or totally edentulous, which can then have significant repercussions on his social life.
EUROTEKNIKA dental implants are intended to be used for the replacement of a dental root in order to support a fixed or mobile prosthesis and thus restore masticatory function. EUROTEKNIKA dental implants are made of titanium or titanium alloy for surgical implants in accordance with ISO5832-2 and -3 standards.
EUROTEKNIKA dental implants are intended for use in cases of single, partial or complete edentulism on the maxillary and/or mandibular arch:
- Single tooth loss,
- Intercalary toothlessness,
- Terminal toothlessness,
- Total edentulism.
Dental implantology is based on the following principle: an implant is surgically inserted into the maxilla or mandible, and then a pillar is connected to this implant to support the dental prosthesis.
The use of dental implants is based on a biological process called osseointegration. Osseointegration corresponding to the fact that certain materials such as titanium are able to form direct contact with the surrounding bone. Osseointegration is therefore the direct structural and functional connection between living bone and the surface of an artificial implant. In order to allow the osseointegration process, and depending on the clinical case, a more or less long healing period must be observed before connecting the prosthetic elements to the implant. In cases of immediate loading, there is no healing period.
The expected benefits of this surgery are to improve the quality of life of patients and to recover masticatory function.
The claimed clinical performances are:
- High primary stability,
- High long-term implant stability,
- Limitation of bone resorption and risks of mucositis and peri-implantitis
- Maintenance of soft tissues.
The objectives of this study are therefore to assess the safety and performance of EUROTEKNIKA dental implants.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prospective | – | Device: dental implantationA prospective cohort will be recruited into the study to meet the secondary objective of improving quality of life. In fact, to measure the improvement in quality of life, a questionnaire must be completed by the patient before the implant is placed. Answers to this questionnaire preoperatively cannot be collected for patients recruited retrospectively. |
| retrospective | – | –Patients who received one or more EUROTEKNIKA implants before 2017 may be included in the study for the retrospective cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received one or more EUROTEKNIKA implants before 2017 may be included in the study for the retrospective cohort for Naturactis, Naturall+, Aesthetica+2, ORIGIN, iBone E, iBone S and iBone G implants. These patients will be included consecutively in chronological order to avoid selection bias. A prospective cohort will also be recruited in the study, in order to meet the secondary objective concerning the improvement of the quality of life. In fact, to measure the improvement in quality of life, a questionnaire must be completed by the patient before the implant is placed. Answers to this questionnaire preoperatively cannot be collected for patients recruited retrospectively.
Key inclusion criteria (7 listed)
- Patient aged 18 or over
- Patient who has completed bone growth
- Patient informed and agreeing to participate in the study
- Partially or totally edentulous patient who will be implanted with the EUROTEKNIKA dental implant (for the prospective cohort)
- Patient to benefit from the placement of an implant for the creation of a single crown (for the prospective cohort)
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding women (for the prospective cohort)
- Patient with bone disease in the cervico-facial region
- Patient refusing to participate in the study
- Patient with at least one contraindication to implantation (for the prospective cohort)
- Patient to benefit from the placement of an implant with immediate or early loading (for the prospective cohort)
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 implantationan implant is surgically inserted into the maxilla or mandible, and then an abutment is connected to this implant to support the dental prosthesis. | Device | prospective |
Primary outcome
The success rate of tissue integration of the implant
Time frame: 5 years after implantation
Integration of the implant 5 years after implantation
7 secondary outcomes
assessment of the quality of life of patients following the recovery of full dentition with the GOHAI score (General Oral Health Assessment Index)
Time frame: 5 years after implantation
Complication rate taking into account pain, local tenderness, infection, mobility of the implant, fracture
Time frame: 5 years after implantation
measuring chewing function after prosthesis placement
Time frame: 5 years after implantation
Rate of inflammation (visual)
Time frame: 5 years after implantation
Assessment of the evolution of the péri-implant tissues
Time frame: 5 years after implantation
assessment of the osseointegration of the implant
Time frame: 5 years after implantation
Rate of infection (x-ray)
Time frame: 5 years after implantation
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 16 May 2022.
- 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.
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 Edentulous Mouth, run by Euroteknika at 1 site in France.
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 7 inclusion and 8 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 16 May 2022. 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 France. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of tissue integration of the implant (time frame: 5 years after implantation). 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 16 May 2022.