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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05130996
Other study ID # 2019-A02389-48
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 9, 2022
Est. completion date June 2024

Study information

Verified date March 2024
Source Implants Diffusion International
Contact Rony BOUKHRIS
Phone 01.48.70.70.48
Email rony.boukhris@idisystem.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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).


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:


Recruitment information / eligibility

Status Recruiting
Enrollment 121
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
dental prothesis
5 ranges of implants can be used : IDAll, IDBio, IDCam, IDMax, ID3

Locations

Country Name City State
France Dental Office Paris

Sponsors (1)

Lead Sponsor Collaborator
Implants Diffusion International

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Osteointegration achieved between 2 and 6 months evaluated by clinical examination Measurement of the stability index of the implant with OSSEO100 between 2 and 6 months after the surgery (dental implantation)
Primary Osteointegration achieved between 2 and 6 months evaluated by radiological examination Measurement of the bone loss between 2 and 6 months after the surgery (dental implantation)
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