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Osseodensification and Dental Implant Stability

A Randomised Control Clinical Trial Investigating the Effect of Osseodensification on Implant Stability and Marginal Bone Levels

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05376020
Enrollment
46
Registered
2022-05-17
Start date
2022-05-13
Completion date
2024-05-13
Last updated
2022-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osseointegration, Osseodensification

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.

Interventions

Conventional Burs will be used in the control group

Densah Burs will be used in the intervention group

Sponsors

University of Dublin, Trinity College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Implant StabilityDuring procedure (implant placement)Implant stability Quotient (ISQ) will be measured using magnetic resonance frequency analysis (MRFA) - the device is called OSSTELL. A transducer is attached to the implant and brought to vibration by magnetic pulses from the probe of the Osstell device which makes the implant vibrate. The implant's resistance to vibration is expressed as the ISQ value. High vibration frequency signifies high implant stability.

Secondary

MeasureTime frameDescription
Insertion torqueDuring procedure (implant placement)Insertion torque of implant will be measured using standard torque wrench
Marginal bone levelsDuring procedure (implant placement)Will be measured clinically using a periodontal probe and radiographically

Countries

Ireland

Contacts

Primary ContactIoanna Politi, B.Dent.Sc
ioanna.polti@dental.tcd.ie+3530862773128
Backup ContactIoannis Polyzois, DMD
ioannis.polyzois@dental.tcd.ie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026