Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible
NCT Number: NCT06486311
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Novel Implant for Immediate Load in Posterior Mandible
Interventions: PROCEDURE: satellite implant
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 8
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-22
Completion Date: 2026-05-31
Locations: Aya Tallah Selim Labib Kaream, Cairo, Shrouk, 4914085, Egypt

Summary:
The research aims to evaluate the long-term effectiveness of satellite implants in the posterior mandible by assessing the levels of crestal bone after six months of first loading and secondary stability issues at fourth-month , primary stability at time of implant loading . In particular, the primary outcome of this study is to assessment stability of satellite implants, which will be evaluated by anycheck device.

Primary Outcome Measures: Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible, After the insertion of the satellite implant, primary stability will be assessed at the time of implant loading using the "AnyCheck" device (Neo Biotech, Seoul, Korea). Introduced in 2017, the AnyCheck device evaluates implant stability through a damping capacity assessment method. It functions by striking the healing abutment six times over a span of three seconds. The contact duration between the impacting rod and the healing abutment is measured and converted into Implant Stability Test (IST) values. These values are quantified on a scale from 1 to 99, where higher IST values indicate greater implant stability or lower mobility. This quantitative measure provides a precise, reproducible method to assess the outcome of implant stability immediately after placement., Immediately post-implantation
Secondary Outcome Measures: Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible, Assessment Tool: Secondary stability will be assessed using the "AnyCheck" device (Neo Biotech, Seoul, Korea). Introduced in 2017, this device specifically measures the damping capacity to evaluate implant stability.

Method: After the removal of the satellite implant four months post-procedure, the AnyCheck device will be employed to measure the secondary stability. The device operates by striking the healing abutment six times over a three-second period. The duration of contact between the impacting rod and the healing abutment is recorded.

Measurement Scale: The recorded contact time is then converted into Implant Stability Test (IST) values, which are displayed on a scale from 1 to 99. Higher IST values indicate greater implant stability, reflecting lower mobility of the implant within the bone., The secondary stability is assessed four months post-implantation for each patient.
Other Outcome Measures: Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible, Measurement Tool: Digital periapical radiographs combined with calibrated dental software.

Method: Crestal bone level will be precisely measured by assessing the interproximal height of bone. This is defined as the distance between the apical end of the first thread of the implant and the most coronal point of the interproximal crestal bone, both buccally and lingually. Measurements will be taken using digital periapical radiographs, which provide high-resolution images allowing for accurate assessment of bone levels.

Data Analysis: The height of the crestal bone will be recorded in millimeters. For each implant, the mean of the buccal and lingual bone heights will be calculated to determine the average crestal bone loss.

Measurement Scale: Measurements will be recorded in millimeters to provide a precise quantitative assessment of bone loss., Crestal bone loss will be assessed at baseline (immediately post-implantation) and six months after the implant procedure. This timeframe allows for the monitoring of early bone remodeling and loss around the satellite implant.