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

Edentulous Alveolar Ridge Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05340959
• Other study ID #: 41193
• Status: Completed
• Start date: December 15, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: October 2023
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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 :

1. Osstell : based on resonance frequency analysis (RFA).

2. Periotest: based on damping effect.

3. AnyCheck: based on tapping motion. Secondary stability will be measured after 12 weeks using the same devices mentioned above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Healthy patients over 18 years of either gender, having single or multiple missing teeth in the maxilla and/or mandible.

2. Patient with adequate vertical bone height and width for implant placement based on preoperative radiographic findings (CBCT).

3. Ability to tolerate conventional surgical and restorative procedures.

4. Patients who are willing to comply with the study and give their consent.

Exclusion Criteria:

1. Active infection or inflammation in the implant zone.

2. Presence of any uncontrolled systemic diseases.

3. Patients with a history of radiotherapy to the head and neck.

4. Any patient requires advanced and complicated surgical techniques such as sinus lift and bone graft.

Related Conditions & MeSH terms

• Edentulous Alveolar Ridge
• Mouth, Edentulous

Intervention

Device:
• Devices: Osstell®, Periotest® and AnyCheck®.
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).

Locations

Country	Name	City	State
Iraq	College of Dentistry, University of Baghdad	Baghdad	Medical City

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant stability measured by Osstell®.	Implant stability will be measured by: Osstell® (RFA) that is measured by Implant Stability Quotient (ISQ) Value.	Changes in implant stability from baseline value measured immediately after implant installation (primary stability) and after 12 weeks (secondary stability).
Primary	Implant stability measured by Periotest®.	Implant stability will be measured by: Periotest® (damping effect) that is measured by Periotest Value (PTV).	Changes in implant stability from baseline value measured immediately after implant installation (primary stability) and after 12 weeks (secondary stability).
Primary	Implant stability measured by AnyCheck®.	Implant stability will be measured by: AnyCheck® (tapping-motion) that is measured by Initial Stability Test (IST) Value.	Changes in implant stability from baseline value measured immediately after implant installation (primary stability) and after 12 weeks (secondary stability).
Primary	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.	Changes in implant stability from baseline value measured immediately after implant installation (primary stability) and after 12 weeks (secondary stability).