Effect of Bone Bioactive Liquid on Osseointegration A Randomized Controlled Trial Assessing Implant Stability and Bone Turnover Markers
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- The study is expected to demonstrate that the application of Bone Bioactive Liquid (BBL) at the implant site enhances osseointegration by improving implant stability and bone turnover activity compared to conventional implant placement.
Study Overview
Brief Summary
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 1 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 2 3 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 Procollagen Type 1 N Terminal Propeptide P1NP C terminal Telopeptide of Type I Collagen CTX I and Osteoprotegerin OPG 4 P1NP is a marker of bone formation reflecting osteoblastic activity and new collagen synthesis making it valuable for assessing early bone healing around implants CTX I on the other hand is a marker of bone resorption and provides insights into osteoclastic activity and bone turnover dynamics 5 The balance between these markers can help determine the effectiveness of BBL in enhancing osseointegration OPG is a crucial regulator of bone remodelling acting as a decoy receptor for receptor activator of nuclear factor kappa B ligand RANKL thereby inhibiting osteoclast differentiation and reducing bone resorption 6 The inclusion of OPG will allow for a more comprehensive assessment of bone homeostasis around dental implants Circadian rhythms influence bone metabolism and turnover as bone resorption markers such as CTX I exhibit diurnal variation peaking in the early morning and decreasing throughout the day 7 8 To minimize circadian variability all blood sample collections will be standardized by drawing venous blood in the morning between 8 00 AM and 10 00 AM ensuring consistency across study participants
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 25.00 Year(s) to 65.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The study is expected to demonstrate that the application of Bone Bioactive Liquid (BBL) at the implant site enhances osseointegration by improving implant stability and bone turnover activity compared to conventional implant placement.
Time Frame: Baseline , 1 month and 3 months post implantation
Secondary Outcomes
- Implant Stability Quotient (ISQ) values measured using Resonance Frequency Analysis (RFA)(Baseline , 1 month & 3 months)
Investigators
D R N Shanmuganathan
Sri Ramachandra Institute of Higher Educatiin and Research