Clinical trial NCT05376020: Osseodensification and Dental Implant Stability
Official title: A Randomised Control Clinical Trial Investigating the Effect of Osseodensification on Implant Stability and Marginal Bone Levels
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osseointegration
Osseodensification
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Patient Level

* Male or Female, 18 years old or over
* Capacity to provide informed consent
* Willing to comply with study appointment schedule Willing to maintain a diary of symptoms
* Planned for provision of dental implant(s) at Dublin Dental University Hospital

Site Level

* Location: maxilla
* Sufficient bone volume for implant placement without the need for bone graft/augmentation; alveolar ridge of minimum 6mm width for standard implants (implant diameter 4mm) and of minimum 7mm for wider implants (implant diameter 5mm)

Exclusion Criteria:

Patient Level

* Plaque score \>20%
* Bleeding score \>20%
* Tobacco smoking
* Uncontrolled systemic disease
* Use of systemic medications with an expected impact on bone healing (e.g. bisphosphonates)
* Pregnancy or lactation
* Lack of capacity to give an informed consent

Site Level

* Location: mandible
* Insufficient bone volume for implant placement, requiring bone graft/augmentation

Primary outcomes:
measure: Implant Stability
timeFrame: During procedure (implant placement)
measure: Implant Stability
timeFrame: At time of second stage implant surgery (3 months)
measure: Implant Stability
timeFrame: At implant restoration (5 months)
Secondary outcomes:
measure: Insertion torque
timeFrame: During procedure (implant placement)
measure: Marginal bone levels
timeFrame: During procedure (implant placement)
measure: Marginal bone levels
timeFrame: At time of second stage implant surgery (3 months)
measure: Marginal bone levels
timeFrame: At implant restoration (5 months)
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Dublin Dental Hospital/Trinity College Dublin
Study officials:
References: