Osseodensification and Dental Implant Stability

Study Overview
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Brief Summary
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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.

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

Conditions
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Osseointegration, Osseodensification

Intervention / Treatment
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* Device: Densah Burs
* Device: Conventional Burs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Densah Burs<br>Intervention Group | Device: Densah Burs<br>* Densah Burs will be used in the intervention group<br>|
| Active Comparator: Conventional Burs<br>Control Group | Device: Conventional Burs<br>* Conventional Burs will be used in the control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) |