Dental ProsthesisNCT05130996
Observational Study Evaluating Safety and Performance of IDI Dental Implant Systems in Subjects Followed for 18 Months.
An observational study of Dental Prosthesis, run by Implants Diffusion International at 1 site in France.
Trial summary
Post-Market Clinical Follow-Up to evaluate the safety and performance of IDI dental implant systems : confirmation of osseointegration of the different implants at the loading visit (between 2 and 6 months after surgery). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Prosthesis
- What is being tested?
- dental prothesis
- Type of treatment
- Medical device
- How many people
- 121 participants
- Where
- 1 siteFrance
- Study dates
- 9 May 2022to Jun 2024
- 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
- Adult, Older adult
Study population: Adult population receiving an IDI implant under the conditions of use intended by the manufacturer.
Who may be able to join
- Subject receiving an insertion of an aesthetic and functional oral prosthesis on IDI implant systems (IDAll, IDBio, IDCam, IDMax or ID3) for at least one of the following indications:
- Single, partial or complete edentulousness
- Stabilization of a removable prosthesis
- Subject having received an information sheet on the study and having indicated their non-objection before starting the procedures specific to the protocol.
- ASA score (American Society of Anesthesiologists) <3.
- If a recent extraction has been performed at the site of the implantation area, the healing period should be at least 2 months.
- Sufficient bone volume (minimum 4mm) to accommodate dental implants.
Who cannot join
- Pregnant or breastfeeding woman.
- Inability of the subject to maintain reasonable oral hygiene in accordance with study requirements.
- Parafunctional habits, such as bruxism or temporomandibular joint disease.
- Different pathologies of the oral mucosa such as: benign mucous pemphigoid, desquamative gingivitis, malignant tumor of the oral cavity, bolus erosive diseases of the oral mucosa.
- Disorders of bone metabolism.
- Untreated, unmanaged caries and / or periodontal disease.
Show all 21Show fewer
- Need for simultaneous bone grafting and / or sinus lift in the intended implant area.
- Medical history making insertion of the implant unfavorable.
- Lack of cooperation. Subject may not comply with study procedures.
- Heavy use of tobacco (more than 10 cigarettes per day), drugs and / or alcohol.
- Treatment with bisphosphonates, steroids or anticonvulsants.
- Unbalanced diabetes.
- Subject receiving radiotherapy, chemotherapy or any other immunosuppressive treatment. Subjects who received radiation therapy to the head and neck area at any time should not be included.
- Congenital or acquired (HIV positive) diseases that compromise the immune system.
- Uncontrolled bleeding disorders such as: haemophilia, thrombocytopenia, granulocytopenia.
- Renal failure.
- Organ transplant recipient.
- Malignant diseases.
- Psychotic illnesses.
- Hypersensitivity to one of the components of the implant in general and to titanium in particular. It is the surgeon's responsibility to ensure that the subject does not have known allergies to any of the components of the material listed on the product label.
- Sports or physical activities including violent shocks.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Dental Office
Paris
Gilles BOUKHRIS
boukhrisgilles@gmail.com
About this study
Official title: Observational Study Evaluating Safety and Performance of Dental Implant Systems (5 Implant Ranges: IDAll, IDBio, IDCam, IDMax, ID3; 3 Types of Prosthetic Parts: Sealed, Screw-retained and Removable) in Subjects Followed During 18 Month
Post-Market Clinical Follow-Up to evaluate the safety and performance of IDI dental implant systems : confirmation of osseointegration of the different implants at the loading visit (between 2 and 6 months after surgery).
Read the detailed description
The aim of the present study is to carry out post-marketing clinical monitoring of the medical device used in accordance with the instructions for use according to a medical strategy intended for the person who is suitable for this research which is not fixed in advance by an investigation plan and is part of the current practice of the surgeon.
This is a comparative, prospective, multicenter observational study
The osteointegration reached between 2 and 6 months after surgery will be evaluated by clinical and radiological examinations:
- Conditions
- Dental Prosthesis
- Being tested
- dental prothesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental prothesisDevice
5 ranges of implants can be used : IDAll, IDBio, IDCam, IDMax, ID3
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteointegration achieved between 2 and 6 months evaluated by clinical examination
Measurement of the stability index of the implant with OSSEO100
Measured: between 2 and 6 months after the surgery (dental implantation)
Osteointegration achieved between 2 and 6 months evaluated by radiological examination
Measurement of the bone loss
Measured: between 2 and 6 months after the surgery (dental implantation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start9 May 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ProsthesisStudies 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
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Implants Diffusion International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130996
- Sponsor's protocol ID
- 2019-A02389-48
- Status last verified
- Mar 2024
- First submitted
- 12 Nov 2021
- Last updated
- 6 Mar 2024
- Results posted
- 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Evaluating Safety and Performance of Dental Implant Systems (5 Implant Ranges: IDAll, IDBio, IDCam, IDMax, ID3; 3 Types of Prosthetic Parts: Sealed, Screw-retained and Removable) in Subjects Followed During 18 Month
- ClinicalTrials.gov ID
- NCT05130996
- Acronym / sponsor ID
- 2019-A02389-48
- Conditions
- Dental Prosthesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Implants Diffusion InternationalIndustry (pharma, biotech, devices)
- Study start
- 9 May 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 23 Nov 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.
Post-Market Clinical Follow-Up to evaluate the safety and performance of IDI dental implant systems : confirmation of osseointegration of the different implants at the loading visit (between 2 and 6 months after surgery).
Detailed description
The aim of the present study is to carry out post-marketing clinical monitoring of the medical device used in accordance with the instructions for use according to a medical strategy intended for the person who is suitable for this research which is not fixed in advance by an investigation plan and is part of the current practice of the surgeon.
This is a comparative, prospective, multicenter observational study
The osteointegration reached between 2 and 6 months after surgery will be evaluated by clinical and radiological examinations:
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult population receiving an IDI implant under the conditions of use intended by the manufacturer.
Key inclusion criteria (7 listed)
- Subject receiving an insertion of an aesthetic and functional oral prosthesis on IDI implant systems (IDAll, IDBio, IDCam, IDMax or ID3) for at least one of the following indications:
- Subject having received an information sheet on the study and having indicated their non-objection before starting the procedures specific to the protocol.
- ASA score (American Society of Anesthesiologists) <3.
- If a recent extraction has been performed at the site of the implantation area, the healing period should be at least 2 months.
- Sufficient bone volume (minimum 4mm) to accommodate dental implants.
Key exclusion criteria (21 listed)
- Pregnant or breastfeeding woman.
- Inability of the subject to maintain reasonable oral hygiene in accordance with study requirements.
- Parafunctional habits, such as bruxism or temporomandibular joint disease.
- Different pathologies of the oral mucosa such as: benign mucous pemphigoid, desquamative gingivitis, malignant tumor of the oral cavity, bolus erosive diseases of the oral mucosa.
- Disorders of bone metabolism.
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 prothesis5 ranges of implants can be used : IDAll, IDBio, IDCam, IDMax, ID3 | Device | – |
Primary outcome
Osteointegration achieved between 2 and 6 months evaluated by clinical examination
Time frame: between 2 and 6 months after the surgery (dental implantation)
Measurement of the stability index of the implant with OSSEO100
Osteointegration achieved between 2 and 6 months evaluated by radiological examination
Time frame: between 2 and 6 months after the surgery (dental implantation)
Measurement of the bone loss
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Dental Prosthesis
Recruiting
Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Peri Implant Mucositis, Dental Implant Rehabilitation
Not yet recruitingObservational study
Plaque and Bleeding on Probing Around Implants Supporting Fixed Full-Arch Dental Prostheses
Peri-Implant Health
RecruitingObservational study
Changes in Oral Health-related Quality of Life (OHRQoL) During Full Arch Implant Treatment
Edentulous Mouth, Quality of Life
Recruiting
Clinical Performance of Dual-cantilevered Single-implant Bridge
Dental Implant Failed
Active, not recruiting
Clinical Performance of All-ceramic Posterior Crowns. A Randomized, Prospective Clinical.
Dental Prosthesis Failure
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.
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 Dental Prosthesis, run by Implants Diffusion International 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 21 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 6 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rony BOUKHRIS (01.48.70.70.48, rony.boukhris@idisystem.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osteointegration achieved between 2 and 6 months evaluated by clinical examination (time frame: between 2 and 6 months after the surgery (dental implantation)). The study lists 2 primary outcomes in all. 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 6 Mar 2024.