Osseodensification and Dental Implant Stability

Not Applicable

• Conditions: Osseodensification; Osseointegration
• Interventions: Device: Densah Burs; Device: Conventional Burs

• Registration Number: NCT05376020
• Lead Sponsor: University of Dublin, Trinity College

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-05
• Study First Submitted QC: 2022-05-10
• Last Update Submitted: 2022-05-10
• Study Start: 2022-05-13
• Study First Posted: 2022-05-17
• Last Update Posted: 2022-05-17
• Primary Completion: 2024-05-13
• Study Completion: 2024-05-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Densah Burs	Densah Burs	Intervention Group
Conventional Burs	Conventional Burs	Control Group

Primary Outcome Measures

Name	Time	Method
Implant Stability	At implant restoration (5 months)	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 Outcome Measures

Name	Time	Method
Insertion torque	During procedure (implant placement)	Insertion torque of implant will be measured using standard torque wrench
Marginal bone levels	At implant restoration (5 months)	Will be measured clinically using a periodontal probe and radiographically

Trial Locations

Locations (1)

Dublin Dental Hospital/Trinity College Dublin; 🇮🇪 Dublin, Ireland