A Randomized, Double-Blind Clinical Human Trial , Bone Bioactive Liquid Efficiency in Improving Implant Osteointegration and Oral Soft Tissue Helling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- ISQ measurements
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Pain Scale
To assess the efficacy of the surgical procedure, pain scale evaluations were conducted on day 1,4 and 7, following the surgery. This evaluation involved a direct contact with the patients to gauge their subjective pain experience. A modified visual analog scale (VAS) was utilized, as described in reference [34]. No pain scale = 0, moderate pain scale = 5 and maximum pain scale = 10 [21]. In addition to efficacy measurements, safety measurements were also considered. The occurrence of adverse events (AEs) and serious adverse events (SAEs) was monitored throughout the duration of the study. These events were either detected by the investigator or reported by the patients themselves. The aim was to identify any potential complications or issues that arose because of the surgical procedure.
干预措施: Dental Implant insertion and tooth extraction (Device)
RFA and ISQ measurements
After the implants were fully seated, a Smartpeg specific to the implant system and restorative platform diameter was used for each implant. RFA was then performed using an OsstellMentor device from Ostell/Integration Diagnostics in Gothenburg, Sweden. This analysis was used to measure the ISQ values for all implant surfaces at days 0, 7 and 30 post-surgeries. For each implant, 4 readings were taken per lingual, mesial, distal, and vestibular direction. The average ISQ values of all the readings were recorded. Following the RFA measurements, new sterile healing abutments were inserted, and the incisions were sutured to close the wounds.
干预措施: Dental Implant insertion and tooth extraction (Device)
CBCT analysis
CBCTs were captured for implants from six patients with total of 24 implants, with 12 implants Galaxy TS (non-treated) on one side of the jaw and 12 implants Galaxy TSA (treated with BBL) on the other side of the jaw. All patients in this group had implants inserted in the upper jaw and each patient had 4 implants inserted (All on 4 technique). The CBCTs scans were conducted at days 1 and 60 post-surgeries using a 3D Accuitomo 170 scanner (J. MORITA EUROPE GMBH). The scans were performed with the following technical parameters: 90 kV, 5 mA, 87.5 mAs, voxel size ranging from 125-250 µm, 360° rotation, and scanning time of 17.5 s as previously described [32]. To ensure accuracy, a bite mark was utilized during CBCT scanning to correspond to the patients' midline. Consistency in bite mark placement was maintained to ensure that the same slice was obtained for each scan performed on the patient
干预措施: Dental Implant insertion and tooth extraction (Device)
结局指标
主要结局
ISQ measurements
时间窗: 3 month
Implant stapelity
次要结局
- CBCTs analysis(2 month)
研究者
Maher Atari Abouasi
Director
Biointelligent Technology Systems SL