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NCT04121364 · ClinicalTrials.gov registry record
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
A clinical trial, sponsored by RevBio.
- Completed
- Registry status
- 20
- Enrollment target
NCT04121364: Completed study, sponsored by RevBio.
NCT04121364 is a clinical trial that has completed, run by RevBio. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04121364 has completed, sponsored by RevBio.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
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 t
Interventions
- DEVICE Tetranite
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-09-27 |
| Est. Completion | 2023-02-27 |
What the finished NCT04121364 record still lists
NCT04121364 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Tetranite is the first listed.
NCT04121364 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04121364 about?
NCT04121364 is a clinical study titled "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". 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.
What is the current status of trial NCT04121364?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2019-09-27. Estimated completion is 2023-02-27.
What interventions are being tested in trial NCT04121364?
The interventions under investigation include: Tetranite (DEVICE).
Who is sponsoring clinical trial NCT04121364?
This trial is sponsored by RevBio, which has 2 total clinical trials registered on ClinicalTrials.gov.
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