Clinical trial NCT06371430: Bone Bioactive Liquid Efficiency in Improving Dental Implant Osteointegration Oral Soft Tissue Hellingand Oral Surgery
Official title: A Randomized, Double-Blind Clinical Human Trial , Bone Bioactive Liquid Efficiency in Improving Implant Osteointegration and Oral Soft Tissue Helling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Healing Disorder
Wounds and Injuries
Wound Surgical
Keywords: Bone bioactive liquid
Dental implant
Oral wound healing
Lead sponsor: Biointelligent Technology Systems SL
Sponsor class: INDUSTRY
Collaborators: name: Universidad Pública de Navarra
name: Dasman Diabetes Institute
First posted: 2024-04-17
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: ISQ measurements
timeFrame: 3 month
Secondary outcomes:
measure: CBCTs analysis
timeFrame: 2 month
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Biointelligent Technology Syst
Study officials:
References: