Evaluating the safety and performance of IDI dental implants over 18 months.
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
This study is testing how safe and effective IDI dental implants are for people getting new teeth over a period of 18 months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 121 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Implants Diffusion International Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Paris) |
| Trial ID | NCT05130996 on ClinicalTrials.gov |
What this trial studies
This observational study aims to monitor the safety and performance of IDI dental implant systems in patients receiving aesthetic and functional oral prostheses. It involves a multicenter approach where participants will be followed for 18 months, with evaluations of osseointegration occurring between 2 and 6 months post-surgery through clinical and radiological examinations. The study is designed to align with current surgical practices and does not follow a fixed investigation plan.
Who should consider this trial
Good fit: Ideal candidates include individuals receiving IDI dental implants for single, partial, or complete edentulousness, or for stabilizing removable prostheses.
Not a fit: Patients who are pregnant, breastfeeding, or unable to maintain proper oral hygiene may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the safety and effectiveness of IDI dental implants, leading to improved patient outcomes in dental prosthetics.
How similar studies have performed: Other studies evaluating dental implant systems have shown promising results, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
Where this trial is running
Paris
- Dental Office — Paris, France (Recruiting)
Study contacts
- Study coordinator: Rony BOUKHRIS
- Email: rony.boukhris@idisystem.fr
- Phone: 01.48.70.70.48
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.