Observational Study Evaluating Safety and Performance of IDI Dental Implant Systems in Subjects Followed for 18 Months.

Launched by IMPLANTS DIFFUSION INTERNATIONAL · Nov 12, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the safety and performance of IDI dental implant systems, which are used to support dental prostheses (artificial teeth). The researchers want to see how well these implants work over a period of 18 months, particularly focusing on whether the implants properly bond with the bone, a process called osseointegration. This study is currently looking for participants aged 65 to 74 who need dental implants for reasons like missing teeth or to stabilize removable dentures.

To be eligible for this trial, participants must be receiving a dental implant from the IDI system and must have enough bone to support the implant. They should also be in good overall health and able to maintain proper oral hygiene. Participants can expect regular follow-ups to check on the progress of their implants and their overall health. It's important to note that certain conditions, like uncontrolled diabetes or recent cancer treatments, may prevent someone from taking part in this study. If you think you might qualify or have questions, consider discussing this with your dentist or healthcare provider.

Gender

ALL

Eligibility 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.