NCT06371430

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

A Randomized, Double-Blind Clinical Human Trial , Bone Bioactive Liquid Efficiency in Improving Implant Osteointegration and Oral Soft Tissue Helling

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Biointelligent Technology Systems SL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Wound Healing Disorder
• Wounds and Injuries
• Wound Surgical

Interventions

Type	Name	Description
DEVICE	Dental Implant insertion and tooth extraction	The osteotomies were carried out at a speed of 800 rpm, using sequential burs of similar diameter for both the maxilar and the mandibular side. The drilling protocols followed the recommendations provided by the manufacturer, the Galaxy-Ziacom implant system, for standard drilling. The insertion of the implants was initiated using a motor handpiece at a speed of 20-50 rpm, without irrigation. The installation process was completed using a manual surgical torque wrench indicator. The maximum torque value (Ncm) reached at the end of implant insertion was recorded as the insertion torque (IT). A total of 264 implants were inserted in 33 patients, 160 implants were post-extraction and 104 implants were inserted after at least one-month post-extraction. The sutures were typically removed 1 week after the surgery, during the postoperative follow-up appointment.

Timeline

• Start date: 2021-04-14
• Primary completion: 2022-06-14
• Completion: 2024-04-14
• First posted: 2024-04-17
• Last updated: 2024-06-04

Locations

1 site across 1 country: Spain