NCT05376020

Osseodensification and Dental Implant Stability

Status unknown NA Last updated 17 May 2022

What this trial tests

NA trial testing Densah Burs in Osseointegration in 46 participants. Status unknown.

Timeline

13 May 2022

Primary endpoint
13 May 2024

13 May 2024

Quick facts

Lead sponsor	University of Dublin, Trinity College
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	46
Start date	13 May 2022
Primary completion	13 May 2024
Estimated completion	13 May 2024
Sites	1 location across Ireland

Drugs / interventions tested

• Densah Burs
• Conventional Burs

Conditions studied

• Osseointegration — all drugs for Osseointegration →
• Osseodensification — all drugs for Osseodensification →

Sponsor

University of Dublin, Trinity College

Who can join

18 and older, any sex, with Osseointegration or Osseodensification. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Osseointegration refers to the formation of a structural and functional bone-to-implant interface, without the interposition of soft tissue. Successful osseointegration will provide long term success for the dental implant. Primary implant stability, is the mechanical stability between bone and the implant at the time of insertion and is key to initiate a successful osseointegration.

Both primary implant stability and osseointegration are affected by the density of the bone where the implant is placed. A relatively new technique known as osseodensification (OD) has been developed and uses specially designed burs (Densah burs). Compared to conventional drills (CD) that remove bone (subtractive drilling) these burs are designed so that they can rotate in a counterclockwise (CCW) (non subtractive) direction which allows bone to be preserved and compacted into the wall of the osteotomy site. These drills therefore theoretically maintain bone volume which then creates higher bone density and bone to implant contact allowing better implant primary stability.

This study will be a randomised control trial comparing OD to CD with regards to implant stability and bone levels. Considering the increased cost of OD, available literature must support a significant clinical benefit of OD over CD to consider them for clinical use. This study will aim to reinforce available clinical research and address some of the limitations of the current evidence to aid clinicians in making an evidenced-based decision on the use of OD when poor bone density could compromise implant success.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Effect of Osseodensification on Implant Stability and Marginal Bone Levels: A Randomized Control Clinical Trial.
   Politi I, Honari B, Winning L, Polyzois I. · · 2025 · cited 2× · PMID 40205940 · DOI 10.1002/cre2.70126