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Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible

NCT06486311 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-12-30
Last updated
2025-02-11

Condition(s) studied

Novel Implant for Immediate Load in Posterior Mandible

Investigational drug(s) / intervention(s)

satellite implant

satellite implant: Satellite implant is a additional holding component as a stabilizer to provide a polygonal support to distribute forces and moments on single-standing implants give the implant sufficient resistance to withstand masticatory forces or at least keep it in a stable position during an unloaded healing period to achieve stabilization and subsequent osseointegration of implants.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria: * Patients requiring implants for the posterior mandible. * Patients aged between 18-45 years old. * Implants must be at least 8mm in length. * A sufficient quantity and distribution of implants to enable cross-arch stability. * Implants must have good initial stability, with insertion torques ranging from 35 to 50 N/cm. * Sufficient bone for implant placement and plate fixation. * Patient able to give informed consent. * Sufficient inter-arch space. Exclusion Criteria: * Contraindications to implant surgery in general. * Bruxism. * Immunosuppression. * History of radiation to the head and neck region. * Uncontrolled diabetes. * Heavy smokers (more than ten cigarettes per day). * Poor oral hygiene. * Current or previous bisphosphonate therapy. * Substance abuse. * Mental illness. * Failure to complete 6-month follow-up. * Pregnancy or breastfeeding. * Insertion torque of less than 35 N/cm. * Removal of interim repair during the osseointegration stage. * Patients suffering from parafunctional behaviors.

Primary outcome measure(s)

  • Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible — Immediately post-implantation
    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.

Trial sites (1)

FacilityCityRegionStatus
Aya Tallah Selim Labib Kaream Cairo Shrouk
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06486311 on ClinicalTrials.gov ↗ ← All trials in Egypt