NCT05535426

Feasibility Study to Assess Outcomes of Immediately Inserted and Restored Dental Implants Using pH-modified Tetranite

A Prospective Human Clinical Study to Assess Primary Stability and Change in Stability by Resonance Frequency Analysis of Immediately Inserted and Restored Dental Implants Using pH-Modified Tetranite® Implant Stabilization Material

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: RevBio · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The aim of this Pilot Study is to demonstrate the safety and efficacy of the use of Tetranite Implant Stabilization Material (TN-ISM) in delivering enhanced stability to immediately restored dental implants inserted into fresh extraction sockets, with both clinical and patient-related successful outcomes.

Detailed description

The purpose of the present study is to evaluate the safety and efficacy of a single stage approach using Tetranite 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 increasing short-term stabilization of implants as the device undergoes initial resorption and replacement with new bone; (3) Third - To demonstrate the ability of TN-ISM to aid in the maintenance of alveolar ridge contours without buccal plate collapse and loss of crestal bone height; and Fourth (4) - To demonstrate and evaluate the ability of a TN-ISM stabilized implant to achieve implant success (after criteria of Buser, et. al 1) after 12 months in situ 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 12 months of post-implant and device placement, the study also assesses several secondary endpoints over the course of the study and one-year follow-up, as outlined in the sections below. These include assessment of incidence, duration, and severity of adverse effects and events; assessment of increasing implant stiffness; assessment of bone levels, bone volumetric changes; patient satisfaction surveys, and assessment of periodontal and peri-implant health integral to implant success.

Conditions

• Adhesive Dental

Interventions

Type	Name	Description
DEVICE	Tetranite Implant Stabilization Material	Dental adhesive for increased implant stabilization

Timeline

• Start date: 2022-09-22
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2022-09-10
• Last updated: 2022-10-26

Locations

1 site across 1 country: United Kingdom