Primary stability of dental implants bonded with modified Tetranite
Research type
Research Study
Full title
A prospective human clinical pilot trial to assess primary stability and change in stability by resonance frequency analysis of immediately inserted and restored dental implants using Tetranite Dental Bone Adhesive Implant Stabilization Material (TN-ISM)
IRAS ID
312556
Contact name
Michael Norton
Contact email
Sponsor organisation
RevBio, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This study follows a previous pilot trial (IRAS# 272223) in which dental implants gained stability when placed into immediate extraction sockets by utilizing a novel class of device which is a bone adhesive, called Tetranite (TN). In the previous pilot study 14 implants were placed in 11 patients and all implants were shown to benefit from immediate enhanced stabilization by means of the use of the device under test. However, 4 implants subsequently failed due to a failure of the site to heal at the bone crest, resulting in bacterial ingress and subsequent inflammation and/or infection with detachment of the glue from the bone socket housing and ultimately implant failure. Improvements in study design with protocol amendments appeared to resolve many issues but the CI, together with the Sponsor determined that the pH of the device was too acidic (5.5) during curing and that this negatively impacted soft tissue healing over the extraction sockets and hence exposed the glue to the oral environment rendering it at risk of infection from oral microbiota. Subsequent in vitro and in vivo tests have revealed that a modified Tetranite bone adhesive, which is called Tetranite Dental Bone Adhesive Implant Stabilization Material (TN-ISM), with a pH of 6.5 results in 0% cell lysis, with animal experiments demonstrating enhanced soft tissue healing. The animal experiment protocol was similar to that used in human pilot study 272223 in an effort to replicate conditions and the pH modified device, TN-ISM, yielded superior results compared to controls using the unmodified TN-SM. Therefore, the purpose of this trial is to enroll a new cohort of 15 patients and to use TN-ISM, incorporating all previously approved amendments to the protocol in order to see if implant failures can be reduced to less than 10% which would be within acceptable limits.
REC name
London - Hampstead Research Ethics Committee
REC reference
22/LO/0414
Date of REC Opinion
17 Jun 2022
REC opinion
Further Information Favourable Opinion