Edentulous Alveolar RidgeNCT05340959
Evaluating Implant Stability Using Three Devices Osstell®, Periotest® and AnyCheck®
An observational study of Edentulous Alveolar Ridge, run by University of Baghdad at 1 site in Iraq.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- Devices: Osstell®, Periotest® and AnyCheck®.
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteIraq
- Study dates
- 15 Dec 2021to 1 Dec 2022
- Phase
- Observational
- 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
Study population: Healthy adults with missing one or more tooth or teeth seeking for dental implant treatment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
College of Dentistry, University of Baghdad
Baghdad, Medical City, 1417
About this study
Official title: Evaluating Implant Stability Using Three Devices Osstell®, Periotest® and AnyCheck®: A Prospective Observational Clinical Study.
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.
Read the detailed description
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.
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- Devices: Osstell®, Periotest® and AnyCheck®.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Adult patient with single or multiple missing tooth or teeth requiring dental implants | Adult patient with single or multiple missing tooth or teeth requiring dental implants, 40 dental implants will be placed in osteotomy sites based on radiographic findings (CBCT), the primary stability will be measured immediately after implant installation and secondary stability will be measured after 12 weeks .
Both primary and secondary stability will be measured by three devices:
1. Osstell®: based on Resonance Frequency Analysis (RFA).
2. Periotest®: based on damping effect.
3. AnyCheck®: based on tapping-motion. Receives: Device: Devices: Osstell®, Periotest® and AnyCheck®. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability measured by Osstell®.
Implant stability will be measured by:
Osstell® (RFA) that is measured by Implant Stability Quotient (ISQ) Value.
Measured: Changes in implant stability from baseline value measured immediately after implant installation (primary stability) and after 12 weeks (secondary stability).
Implant stability measured by Periotest®.
Implant stability will be measured by:
Periotest® (damping effect) that is measured by Periotest Value (PTV).
Measured: Changes in implant stability from baseline value measured immediately after implant installation (primary stability) and after 12 weeks (secondary stability).
Implant stability measured by AnyCheck®.
Implant stability will be measured by:
AnyCheck® (tapping-motion) that is measured by Initial Stability Test (IST) Value.
Measured: 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 the devices
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.
Measured: Changes in implant stability from baseline value measured immediately after implant installation (primary stability) and after 12 weeks (secondary stability).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start15 Dec 2021
- Primary completion1 Sep 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alamin Yassin Dhahi, University of Baghdad
- Investigators
- Alamin Y. Dhahi, B.D.S, Principal investigator, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340959
- Sponsor's protocol ID
- 41193
- Status last verified
- Oct 2023
- First submitted
- 27 Mar 2022
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Implant Stability Using Three Devices Osstell®, Periotest® and AnyCheck®: A Prospective Observational Clinical Study.
- ClinicalTrials.gov ID
- NCT05340959
- Acronym / sponsor ID
- 41193
- Conditions
- Edentulous Alveolar Ridge
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 22 Apr 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.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patient with single or multiple missing tooth or teeth requiring dental implants | – | Device: Devices: Osstell®, Periotest® and AnyCheck®.Adult patient with single or multiple missing tooth or teeth requiring dental implants, 40 dental implants will be placed in osteotomy sites based on radiographic findings (CBCT), the primary stability will be measured immediately after implant installation and secondary stability will be measured after 12 weeks . Both primary and secondary stability will be measured by three devices: 1. Osstell®: based on Resonance Frequency Analysis (RFA). 2. Periotest®: based on damping effect. 3. AnyCheck®: based on tapping-motion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults with missing one or more tooth or teeth seeking for dental implant treatment.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Devices: Osstell®, Periotest® and AnyCheck®.1. 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. 2. 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. 3. 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). | Device | Adult patient with single or multiple missing tooth or teeth requiring dental implants |
Primary outcome
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.
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).
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.
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: 1. Osstell® (RFA): measured by Implant Stability Quotient (ISQ) Value. 2. Periotest® (damping effect): measured by Periotest Value (PTV). 3. AnyCheck® (tapping-motion): measured by Initial Stability Test (IST) Value.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
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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.
Alamin Y. Dhahi, B.D.S principal investigator
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edentulous Alveolar Ridge, run by University of Baghdad at 1 site in Iraq.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 3 Oct 2023. 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 Iraq. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2023.