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

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.

Study Overview

• Status: Completed
• Conditions: Edentulous Alveolar Ridge
• Intervention / Treatment: Device: Devices: Osstell®, Periotest® and AnyCheck®.

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 :

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.

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Iraq
  • Medical City
    • Baghdad, Medical City, Iraq, 1417
      • College of Dentistry, University of Baghdad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy adults with missing one or more tooth or teeth seeking for dental implant treatment.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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: Osstell®: based on Resonance Frequency Analysis (RFA).; Periotest®: based on damping effect.; AnyCheck®: based on tapping-motion.

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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).
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).

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Principal Investigator: Alamin Y. Dhahi, B.D.S, University of Baghdad

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: March 27, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 1, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: 41193

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No