OsseointegrationNCT05376020
Osseodensification and Dental Implant Stability
A study testing Densah Burs and Conventional Burs in people with Osseointegration and Osseodensification, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osseointegration, Osseodensification
- What is being tested?
- Densah Burs and Conventional Burs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIreland
- Study dates
- 13 May 2022to 13 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Ioannis Polyzois, DMD contact
Ireland1 site, 1 recruiting
- Recruiting
Dublin Dental Hospital/Trinity College Dublin
Dublin
Ioanna Politi
About this study
Official title: 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.
- Conditions
- Osseointegration, Osseodensification
- Being tested
- Densah Burs, Conventional Burs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Densah BursDevice
Densah Burs will be used in the intervention group
Conventional BursDevice
Conventional Burs will be used in the control group
| Study group | Role | What they receive |
|---|---|---|
| Densah Burs | Experimental | Intervention Group Receives: Device: Densah Burs |
| Conventional Burs | Active comparator | Control Group Receives: Device: Conventional Burs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At implant restoration (5 months)
Secondary outcomes (4)
Insertion torque
Insertion torque of implant will be measured using standard torque wrench
Measured: During procedure (implant placement)
Marginal bone levels
Will be measured clinically using a periodontal probe and radiographically
Measured: During procedure (implant placement)
Marginal bone levels
Will be measured clinically using a periodontal probe
Measured: At time of second stage implant surgery (3 months)
Marginal bone levels
Will be measured clinically using a periodontal probe and radiographically
Measured: At implant restoration (5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start13 May 2022 (estimated)
- Primary completion13 May 2024 (estimated)
- Study completion13 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsseointegrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioanna Politi, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376020
- Sponsor's protocol ID
- IPoliti
- Status last verified
- May 2022
- First submitted
- 5 May 2022
- Last updated
- 17 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40205940
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Clinical Trial Investigating the Effect of Osseodensification on Implant Stability and Marginal Bone Levels
- ClinicalTrials.gov ID
- NCT05376020
- Acronym / sponsor ID
- IPoliti
- Conditions
- Osseointegration, Osseodensification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Study start
- 13 May 2022 (estimated)
- Primary completion
- 13 May 2024 (estimated)
- Study completion
- 13 May 2024 (estimated)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Densah Burs | Experimental | Device: Densah BursIntervention Group |
| Conventional Burs | Active comparator | Device: Conventional BursControl Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- Patient Level
- Plaque score >20%
- Bleeding score >20%
- Tobacco smoking
- Uncontrolled systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Densah BursDensah Burs will be used in the intervention group | Device | Densah Burs |
| Conventional BursConventional Burs will be used in the control group | Device | Conventional Burs |
Primary outcome
Implant Stability
Time frame: During procedure (implant placement)
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.
Implant Stability
Time frame: At time of second stage implant surgery (3 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.
Implant Stability
Time frame: 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.
4 secondary outcomes
Insertion torque
Time frame: During procedure (implant placement)
Marginal bone levels
Time frame: During procedure (implant placement)
Marginal bone levels
Time frame: At time of second stage implant surgery (3 months)
Marginal bone levels
Time frame: At implant restoration (5 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Derived from this study: PubMed 40205940Politi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ioannis Polyzois, DMD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Densah Burs and Conventional Burs in people with Osseointegration and Osseodensification, run by University of Dublin, Trinity College at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ioanna Politi, B.Dent.Sc (+3530862773128, ioanna.polti@dental.tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Stability (time frame: During procedure (implant placement)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05376020, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.