Osseodensification and Dental Implant Stability

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osseointegration; Osseodensification
• Intervention / Treatment: Device: Densah Burs; Device: Conventional Burs

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ioanna Politi, B.Dent.Sc; Phone Number: +3530862773128; Email: ioanna.polti@dental.tcd.ie
• Study Contact Backup: Name: Ioannis Polyzois, DMD; Email: ioannis.polyzois@dental.tcd.ie

Study Locations

• Ireland
  • Dublin, Ireland
    • Recruiting
    • Dublin Dental Hospital/Trinity College Dublin
    • Contact: Ioanna Politi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Densah Burs; Intervention Group	Device: Densah Burs; Densah Burs will be used in the intervention group
Active Comparator: Conventional Burs; Control Group	Device: Conventional Burs; Conventional Burs will be used in the control group

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Dublin, Trinity College

Study record dates

Study Major Dates

• Study Start (Anticipated): May 13, 2022
• Primary Completion (Anticipated): May 13, 2024
• Study Completion (Anticipated): May 13, 2024

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IPoliti

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No