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

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).

Study Overview

• Status: Recruiting
• Conditions: Dental Prosthesis
• Intervention / Treatment: Device: dental prothesis

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 Type: Observational
• Enrollment (Estimated): 121

Contacts and Locations

• Study Contact: Name: Rony BOUKHRIS; Phone Number: 01.48.70.70.48; Email: rony.boukhris@idisystem.fr

Study Locations

• France
  • Paris, France
    • Recruiting
    • Dental Office
    • Contact: Gilles BOUKHRIS
    • Contact: Email: boukhrisgilles@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Implants Diffusion International

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2019-A02389-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No