Osseodensification and Dental Implant Stability

University of Dublin, Trinity College

Status: Unknown

Conditions: Osseodensification; Osseointegration

Treatments: Device: Densah Burs; Device: Conventional Burs

Study type: Interventional

Funder types: Other

Identifiers

NCT05376020

IPoliti

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Densah Burs

Experimental group

Description:

Intervention Group

Treatment:

Device: Densah Burs

Conventional Burs

Active Comparator group

Description:

Control Group

Treatment:

Device: Conventional Burs