Immediate Placement and Stabilization of Dental Implants with TN-ISM
Research type
Research Study
Full title
Immediate Placement and Stabilization of Dental Implants with Tetranite® Implant Stabilization Material in Mandibular and Maxillary Tooth Extraction Sites that Fail to Provide Adequate Primary Stability
IRAS ID
318676
Contact name
Azim Malik
Contact email
Sponsor organisation
RevBio, Inc.
Clinicaltrials.gov Identifier
NCT0690617
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The purpose of the present study is to evaluate the safety and efficacy of a single stage approach using Tetranite® Dental Bone Adhesive Implant Stabilization Material (TN-ISM). The purpose of the efficacy component of this study is a composite comprising: (1) First – To demonstrate and evaluate the ability of TN-ISM to achieve immediate implant stabilization in sites otherwise unable to provide primary stability without requiring the delay in treatment imposed by the current multi-staged standard-of-care method; (2) Second - To demonstrate and evaluate the ability of TN-ISM to achieve short-term stabilization of implants as the device undergoes initial resorption and replacement with new bone; and (3) Third - To demonstrate and evaluate the ability of a TN-ISM stabilized implant to achieve implant success (after criteria of Buser, et. al.) after 6 months of functional loading while the device undergoes significant resorption, facilitates osteoconduction, and replacement with new bone. In addition to the Primary Endpoints of establishing the Safety and Efficacy of Implant Stabilization and Implant Success throughout the initial 6 months of post-functional loading, the study also assesses several secondary endpoints over the course of the study and one-year follow-up. These include assessment of incidence, duration, and severity of adverse effects and events; assessment of implant success; assessment of bone level, volume and density changes; patient satisfaction surveys, and assessment of periodontal and peri-implant health integral to implant success.
This study is a multicentre study of a pH-modified formulation of Tetranite that was developed in response to results of two pilot studies using the initial formulation: one conducted in the US and one conducted in the UK (IRAS ID#272223). A second pilot study of the modified Tetranite formulation has been approved and is in progress in the UK (IRAS ID# 312556).
REC name
London - Stanmore Research Ethics Committee
REC reference
24/LO/0741
Date of REC Opinion
24 Dec 2024
REC opinion
Further Information Favourable Opinion