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

Wounds and Injuries Clinical Trial

— BBLIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06371430
• Other study ID #: Biointelligent Technology Syst
• Status: Recruiting
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: June 14, 2024

Study information

• Verified date: April 2024
• Source: Biointelligent Technology Systems SL
• Contact: Maher Atari, PhD
• Phone: 0034628379586
• Email: matari[@]biointelligentsl.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: June 14, 2024
• Est. primary completion date: February 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Wound
• Wound Healing Disorder
• Wound Surgical
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Spain	Biointelligent Technology Syst	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Biointelligent Technology Systems SL	Dasman Diabetes Institute, Universidad Pública de Navarra

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ISQ measurements	Implant stapelity	3 month
Primary	Pain	Visual Analog Score for pain	7 days
Secondary	CBCTs analysis	Quantify new bon formation	2 month