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

NCT05130996 | Recruiting

• 1 other identifier: 2019-A02389-48
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Dental Prosthesis

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Interventions

dental prothesis DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult population receiving an IDI implant under the conditions of use intended by the manufacturer.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Implants Diffusion International: lead

Study Sites (1)

Dental Office

Paris, France

RECRUITING

Central Study Contacts

Rony BOUKHRIS

CONTACT

01.48.70.70.48; rony.boukhris@idisystem.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 23, 2021
• Study Start: May 9, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)