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Completed

NCT Number: NCT05340959

Evaluating Implant Stability Using Three Devices Osstell®, Periotest® and AnyCheck®

A prospective observational study guided by the guidelines of Strengthening The Reporting Of Observational Study in Epidemiology (STROBE) in 2014, that will be conducted to evaluate implant stability using three devices; Osstell®, Peiotest® and AnyCheck® and comparing the results.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

College of Dentistry, University of Baghdad

Baghdad, Medical City, 1417, Iraq

About this study

In this study, 40 dental implants will be installed in osteotomy sites for patients with single or multiple missing tooth or teeth based on radiographic findings (CBCT).

The primary stability will be measured immediately after implant installation using three devices :

  • Osstell : based on resonance frequency analysis (RFA).
  • Periotest: based on damping effect.
  • AnyCheck: based on tapping motion. Secondary stability will be measured after 12 weeks using the same devices mentioned above.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy patients over 18 years of either gender, having single or multiple missing teeth in the maxilla and/or mandible.
  • Patient with adequate vertical bone height and width for implant placement based on preoperative radiographic findings (CBCT).
  • Ability to tolerate conventional surgical and restorative procedures.
  • Patients who are willing to comply with the study and give their consent.

Exclusion criteria

  • Active infection or inflammation in the implant zone.
  • Presence of any uncontrolled systemic diseases.
  • Patients with a history of radiotherapy to the head and neck.
  • Any patient requires advanced and complicated surgical techniques such as sinus lift and bone graft.

Treatment and study plan

Devices: Osstell®, Periotest® and AnyCheck®.

Device
  • Osstell®: is a device that measure implant stability and based on resonance frequency analysis (RFA). Due to stiffness in the interface between the implant surface and the bone smart peg will vibrates accordingly. the more dense bone the higher stability, the higher frequency and higher Implant Stability Quotient (ISQ) value which is from 1-100.
  • Periotest®: is a device used to assess osseointegration of dental implants, so it measure implant stability . it is based on damping effect of implant. Showing the measurement digitally on a scale from -8 (low mobility) to 50 (high mobility) PTV units.
  • AnyCheck®: this is an implant stability meter that measures the stiffness of alveolar bone-implant interface through a tapping motion. Showing the measurement on a scale from 30 (low stability) to 85 (high stability).

Primary outcomes

  1. Implant stability measured by Osstell®.

    Time frame: Changes in implant stability from baseline value measured immediately after implant installation (primary stability) and after 12 weeks (secondary stability).

    Implant stability will be measured by:

    Osstell® (RFA) that is measured by Implant Stability Quotient (ISQ) Value.

  2. Implant stability measured by Periotest®.

    Time frame: Changes in implant stability from baseline value measured immediately after implant installation (primary stability) and after 12 weeks (secondary stability).

    Implant stability will be measured by:

    Periotest® (damping effect) that is measured by Periotest Value (PTV).

  3. Implant stability measured by AnyCheck®.

    Time frame: Changes in implant stability from baseline value measured immediately after implant installation (primary stability) and after 12 weeks (secondary stability).

    Implant stability will be measured by:

    AnyCheck® (tapping-motion) that is measured by Initial Stability Test (IST) Value.

  4. Correlation between values obtained by the devices

    Time frame: Changes in implant stability from baseline value measured immediately after implant installation (primary stability) and after 12 weeks (secondary stability).

    Correlation between values obtained by:

    • Osstell® (RFA): measured by Implant Stability Quotient (ISQ) Value.
    • Periotest® (damping effect): measured by Periotest Value (PTV).
    • AnyCheck® (tapping-motion): measured by Initial Stability Test (IST) Value.

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

Evaluating Implant Stability Using Three Devices Osstell®, Periotest® and AnyCheck®: A Prospective Observational Clinical Study.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2022
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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