NCT04121364

Immediate Placement and Stabilization of Dental Implants With Tetranite Stabilization Material in Mandibular and Maxillary Tooth Extraction Sites That Fail to Provide Adequate Primary Stability

Immediate Placement and Stabilization of Dental Implants With Tetranite® Stabilization Material in Mandibular and Maxillary Tooth Extraction Sites That Fail to Provide Adequate Primary Stability

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: RevBio · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study is to determine if a new bone adhesive is useful in stabilizing dental tooth implants. Data collected from the study will examine the strength, performance, and the safety of the material.

Detailed description

This is a prospective, multi-center, single arm, pilot clinical study evaluating the use of TN-SM for implant stabilization immediately after tooth extraction. The purpose of this pilot study is to test performance characteristics and capabilities of study design, recruitment criteria, procedures, measures, and operational strategies that are under consideration for use in a subsequent, larger clinical pivotal study. The purpose of the subsequent study will be to provide data demonstrating the safety and efficacy for the use of TN-SM to provide immediate and continued stabilization of implants placed into otherwise unstable sites. Use of TN-SM eliminates the need for the standard practice of bone grafting after tooth extraction and staged implant placement, significantly shortening the overall length of this treatment.

Conditions

• Adhesive Dental

Interventions

Type	Name	Description
DEVICE	Tetranite	Dental Adhesive for increased implant stability

Timeline

• Start date: 2019-09-27
• Primary completion: 2022-03-10
• Completion: 2023-02-27
• First posted: 2019-10-09
• Last updated: 2024-02-21
• Results posted: 2024-02-21

Locations

1 site across 1 country: United States