Clinical trial NCT05340959: Evaluating Implant Stability Using Three Devices Osstell®, Periotest® and AnyCheck®
Official title: Evaluating Implant Stability Using Three Devices Osstell®, Periotest® and AnyCheck®: A Prospective Observational Clinical Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Edentulous Alveolar Ridge
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults with missing one or more tooth or teeth seeking for dental implant treatment.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Implant stability measured by Osstell®.
timeFrame: Changes in implant stability from baseline value measured immediately after implant installation (primary stability) and after 12 weeks (secondary stability).
measure: Implant stability measured by Periotest®.
timeFrame: Changes in implant stability from baseline value measured immediately after implant installation (primary stability) and after 12 weeks (secondary stability).
measure: Implant stability measured by AnyCheck®.
timeFrame: Changes in implant stability from baseline value measured immediately after implant installation (primary stability) and after 12 weeks (secondary stability).
measure: Correlation between values obtained by the devices
timeFrame: Changes in implant stability from baseline value measured immediately after implant installation (primary stability) and after 12 weeks (secondary stability).
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: College of Dentistry, University of Baghdad
state: Medical City
Study officials:
affiliation: University of Baghdad
name: Alamin Y. Dhahi, B.D.S
role: PRINCIPAL_INVESTIGATOR
References: