NCT05376020

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

May 13, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2024

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

May 5, 2022

Last Update Submit

May 10, 2022

Conditions

OsseointegrationOsseodensification

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Insertion torque

    During procedure (implant placement)

  • Marginal bone levels

    During procedure (implant placement)

  • Marginal bone levels

    At time of second stage implant surgery (3 months)

  • Marginal bone levels

    At implant restoration (5 months)

Study Arms (2)

Densah Burs

EXPERIMENTAL

Intervention Group

Device: Densah Burs

Conventional Burs

ACTIVE COMPARATOR

Control Group

Device: Conventional Burs

Interventions

Densah BursDEVICE

Densah Burs will be used in the intervention group

Densah Burs
Conventional BursDEVICE

Conventional Burs will be used in the control group

Conventional Burs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dublin Dental Hospital/Trinity College Dublin

Dublin, Ireland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40205940DERIVED

Central Study Contacts

Ioanna Politi, B.Dent.Sc

CONTACT

+3530862773128ioanna.polti@dental.tcd.ie

Ioannis Polyzois, DMD

CONTACT

ioannis.polyzois@dental.tcd.ie

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 5, 2022

First Posted

May 17, 2022

Study Start

May 13, 2022

Primary Completion

May 13, 2024

Study Completion

May 13, 2024

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)