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

Completed Results posted Last updated 21 February 2024

What this trial tests

trial testing Tetranite in Adhesive Dental in 20 participants. Completed in 27 February 2023.

Timeline

27 September 2019

Primary endpoint
10 March 2022

27 February 2023

Quick facts

Lead sponsor	RevBio
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	27 September 2019
Primary completion	10 March 2022
Estimated completion	27 February 2023
Sites	1 location across United States

Drugs / interventions tested

• Tetranite

Conditions studied

• Adhesive Dental — all drugs for Adhesive Dental →

Sponsor

RevBio — full company profile →

Who can join

21 and older, any sex, with Adhesive Dental. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Implant Success (Modified Buser Criteria) Primary · 6 months

The primary endpoint is a composite measure of implant success (after criteria of Buser, et. al.1) at six-month post-functional loading consisting of: * Presence of the implant at its site of implantation; and, * Absence of a recurrent peri-implant infection with suppuration; and, * Absence of mobility, defined as: * Lack of implant rotation subjected to 20 Ncm of clockwise torque applied 15 minutes after implant placement; and. * Lack of implant rotation subjected to 35 Ncm of clockwise torque applied 13 weeks after implant placement; and, * No construct mobility upon palpation at 6 m

Group	Value	95% CI
Tetranite	6

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected throughout the study: from device/implant placement through the 24 month post-loading follow-up. Additionally, patients who experienced an implant failure were followed for adverse events through 12 months post-implant failure.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tetranite

Serious: 13/20 (65%)

Deaths: 0/20

Serious adverse events (1 terms)

Reaction	System	Tetranite
Implant Loss	Infections and infestations	—

Other adverse events (1 terms — click to expand)

Reaction	System	Tetranite
Suppuration	Infections and infestations	—

Most-reported serious reactions: Implant Loss.

Data from ClinicalTrials.gov NCT04121364 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.