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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Densah Burs | Experimental | Intervention Group |
|
| Conventional Burs | Active Comparator | Control Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Densah Burs | Device | Densah Burs will be used in the intervention group |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Stability | 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. | During procedure (implant placement) |
| Implant Stability | 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. | At time of second stage implant surgery (3 months) |
| Implant Stability | 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. | At implant restoration (5 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Insertion torque | Insertion torque of implant will be measured using standard torque wrench | During procedure (implant placement) |
| Marginal bone levels | Will be measured clinically using a periodontal probe and radiographically |
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Inclusion Criteria:
Patient Level
Site Level
Exclusion Criteria:
Patient Level
Site Level
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ioanna Politi, B.Dent.Sc | Contact | +3530862773128 | ioanna.polti@dental.tcd.ie | |
| Ioannis Polyzois, DMD | Contact | ioannis.polyzois@dental.tcd.ie |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dublin Dental Hospital/Trinity College Dublin | Recruiting | Dublin | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40205940 | Derived | 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. |
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| Conventional Burs |
| Device |
Conventional Burs will be used in the control group |
|
| During procedure (implant placement) |
| Marginal bone levels | Will be measured clinically using a periodontal probe | At time of second stage implant surgery (3 months) |
| Marginal bone levels | Will be measured clinically using a periodontal probe and radiographically | At implant restoration (5 months) |