Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371430
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2024-04-09
Brief Title:
Bone Bioactive Liquid Efficiency in Improving Dental Implant Osteointegration Oral Soft Tissue Hellingand Oral Surgery
Sponsor:
Biointelligent Technology Systems SL
Organization:
Biointelligent Technology Systems SL
Study Overview
Official Title:
A Randomized Double-Blind Clinical Human Trial Bone Bioactive Liquid Efficiency in Improving Implant Osteointegration and Oral Soft Tissue Helling
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BBLIS
Brief 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None