Bone Bioactive Liquid Efficiency in Improving Dental Implant Osteointegration Oral Soft Tissue Hellingand Oral Surgery

Last updated: June 3, 2024
Sponsor: Biointelligent Technology Systems SL
Overall Status: Completed

Phase

N/A

Condition

Pressure Ulcer

Treatment

Dental Implant insertion and tooth extraction

Clinical Study ID

NCT06371430
Biointelligent Technology Syst
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

inclusion criteria:

  • Age 18 years or older.

  • sufficient residual bone volume to accommodate implant placement without requiring bone augmentation, minimum ridge height and width of ≥ 9mm and ≥ 6mm, respectively, and healed bone sites with a minimum of 1 months of post-extraction healing.

exclusion criteria

  • Patients with alcoholism.

  • Smoking habits.

  • History of illicit drug use were excluded.

  • Patients with heart diseases.

  • Diabetes.

  • Previous bone regenerative or augmentation procedures.

  • Bleeding disorders.

  • Compromised immune systems.

  • History of radiation therapy

  • Treatment with steroids or bisphosphonates

Study Design

Total Participants: 33
Treatment Group(s): 1
Primary Treatment: Dental Implant insertion and tooth extraction
Phase:
Study Start date:
April 14, 2021
Estimated Completion Date:
April 14, 2024

Study 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.

Connect with a study center

  • Biointelligent Technology Syst

    Barcelona, 08009
    Spain

    Site Not Available

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