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Clinical Trial Summary

The investigators implanted 264 Galaxy TS implants (with or without BBL) in 33 patients across both jaws. Implant stability and osseointegration were assessed using Initial Stability Quotient (ISQ) measurements, computed tomography (CBCT) scans and pain evaluations at various intervals post-surgery. Further, implant surfaces were examined using scanning electron microscopy (SEM) and atomic force microscopy (AFM). In vitro studies evaluated the efficacy of BBL on dental pulp pluripotent stem cells (DPPSCs) osteogenesis, and inflammatory factor modulation in human macrophages.


Clinical Trial Description

Ensuring implant stability and longevity is pivotal for patient satisfaction and quality of life. Our recent discovery, BBL, novel bone bioactive liquid, demonstrated promising properties in improving implant surfaces, alleviating pain, and expediting oral healing. In this multi-center randomized, double-blind clinical trial, investigators sought to evaluate the impact of BBL on the clinical performance of Galaxy TS implants. Methods Investigators implanted 264 Galaxy TS implants (with or without BBL) in 33 patients across both jaws. Implant stability and osseointegration were assessed using Initial Stability Quotient (ISQ) measurements, computed tomography (CBCT) scans and pain evaluations at various intervals post-surgery. Further, implant surfaces were examined using scanning electron microscopy (SEM) and atomic force microscopy (AFM). In vitro studies evaluated the efficacy of BBL on dental pulp pluripotent stem cells (DPPSCs) osteogenesis, and inflammatory factor modulation in human macrophages. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06371430
Study type Interventional
Source Biointelligent Technology Systems SL
Contact Maher Atari, PhD
Phone 0034628379586
Email matari@biointelligentsl.com
Status Recruiting
Phase N/A
Start date April 14, 2021
Completion date June 14, 2024

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