Evaluation of the Effect of Bone Bioactive Liquid on Osseointegration A Randomised Control Trial Assessing Primary stability and Bone Turnover Markers
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 1
研究概览
简要总结
Dental implants have revolutionized modern dentistry offering a predictable and durable solution for the replacement of missing teeth However ensuring optimal osseointegration remains a critical factor for long term success Various adjunctive therapies have been explored to enhance bone formation around implants including the application of bioactive substances Bone Bioactive Liquid BBL is a promising biostimulatory agent that may accelerate bone healing by modulating bone metabolism and enhancing implant stability
BBL is formulated with osteoinductive and osteoconductive components that can promote early bone remodelling improve mineralization and enhance the integration of implants with the surrounding bone BBL acts by upregulating osteogenic differentiation pathways and modulating inflammatory responses which are essential for optimal implant stability The assessment of bone turnover through serum biomarkers provides insight into the biological response following implant placement Additionally primary stability is a crucial determinant of implant success which can be objectively measured using resonance frequency analysis RFA via the Ostell device Three key bone turnover markers will be analyzed in this study
Three markers with complementary biologic roles were selected Osteocalcin is a non collagenous protein produced by osteoblasts and is widely regarded as a marker of bone formation and mineralization activity NTX N terminal telopeptide of type I collagen reflects degradation of type I collagen and serves as a marker of bone resorption BAP bone specific alkaline phosphatase is an enzyme associated with osteoblastic differentiation and matrix mineralization providing an additional indicator of bone formation Together these markers permit assessment of the balance between bone formation and resorption during the healing period Combining serial ISQ measurements with osteocalcin NTX and BAP assessment allows evaluation of both clinical stability and underlying remodeling dynamics This clinical trial therefore aims to evaluate whether BBL application improves osseointegration in a measurable and clinically relevant manner by assessing implant stability over time using ISQ and by quantifying systemic bone remodeling responses using osteocalcin NTX and BAP
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients who are willing to replace the missing teeth with implants in single or multiple edentulous sites with Adequate bone height of 10mm and bone width of 6mm No systemic illness.
排除标准
- •Uncontrolled diabetics mellitus History of bone metabolic disorders History of smoking more than 10 cigarettes per day Inadequate bone volume Presence of untreated periapical kesions , cysts and tumours pregnancy and lactating mothers.
研究者
D R N Shanmuganathan
Sri Ramachandra Dental College and Hospitals
