Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
46 participants
INTERVENTIONAL
2022-05-13
2024-05-13
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Densah Burs
Intervention Group
Densah Burs
Densah Burs will be used in the intervention group
Conventional Burs
Control Group
Conventional Burs
Conventional Burs will be used in the control group
Interventions
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Densah Burs
Densah Burs will be used in the intervention group
Conventional Burs
Conventional Burs will be used in the control group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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University of Dublin, Trinity College
OTHER
Responsible Party
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Ioanna Politi
Principal Investigator
Locations
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Dublin Dental Hospital/Trinity College Dublin
Dublin, , Ireland
Countries
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Central Contacts
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Facility Contacts
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Ioanna Politi
Role: primary
References
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Politi I, Honari B, Winning L, Polyzois I. The Effect of Osseodensification on Implant Stability and Marginal Bone Levels: A Randomized Control Clinical Trial. Clin Exp Dent Res. 2025 Feb;11(1):e70126. doi: 10.1002/cre2.70126.
Other Identifiers
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IPoliti
Identifier Type: -
Identifier Source: org_study_id
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