| CTRI Number |
CTRI/2025/08/092752 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study comparing the dental implant stability and bone healing in patients receiving dental implants treated with bone regenerative liquid vs those with untreated dental implants |
|
Scientific Title of Study
|
Effect of Bone Bioactive Liquid on Osseointegration A Randomized Controlled Trial Assessing Implant Stability and Bone Turnover Markers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
D R N Shanmuganathan |
| Designation |
Head of the Department |
| Affiliation |
Sri Ramachandra Institute of Higher Educatiin and Research |
| Address |
Sri Ramachandra Dental College,
Room No 8 ,
Department of Prosthodontics,
1,Mount Poonamalle Road,
sri ramachandra nagar ,
Iyyapanthangal,
Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9840231829 |
| Fax |
|
| Email |
shanmuganathan.n@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A R Sowmya Ranjana |
| Designation |
Postgraduate |
| Affiliation |
Sri Ramachandra Institute of Higher Educatiin and Research |
| Address |
Sri Ramachandra Dental College,
Room No 8 ,
Department of Prosthodontics,
1,Mount Poonamalle Road,
sri ramachandra nagar ,
Iyyapanthangal,
Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9353451968 |
| Fax |
|
| Email |
d0323001@sriher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
D R N Shanmuganathan |
| Designation |
Head of the Department |
| Affiliation |
Sri Ramachandra Institute of Higher Educatiin and Research |
| Address |
Sri Ramachandra Dental College,
Room No 8 ,
Department of Prosthodontics,
1,Mount Poonamalle Road,
sri ramachandra nagar ,
Iyyapanthangal,
Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9840231829 |
| Fax |
|
| Email |
shanmuganathan.n@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sowmya Ranjana |
| Address |
Plot no 161, SF1, Moms nest ,
maduram nagar second street ,
periyakolathuvancheri ,
iyyapanthangal,
chennai- 600121 |
| Type of Sponsor |
Other [Others [ Self ] ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR N Shanmuganathan |
Sri Ramachandra Institute of Higher Eduction and Research |
Room No 8 ,
Department of Prosthodontics,
1,Mount Poonamalle Road,
sri ramachandra nagar ,
Iyyapanthangal,
Chennai-600116
Chennai
TAMIL NADU |
9840231829
shanmuganathan.n@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients who are willing to replace the missing teeth with implants in single or multiple edentulous sites. |
| Patients |
(1) ICD-10 Condition: K063||Horizontal alveolar bone loss, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bone Bioactive Liquid [ BBL ] |
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.Implants will be placed following standard surgical protocols, and BBL will be applied/treated in the intervention group immediately before implant placement. |
| Comparator Agent |
NIL |
Implants will be placed following standard surgical protocols and implant site will receive an untreated implant |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
Baseline , 1 month and 3 months post implantation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Implant Stability Quotient (ISQ) values measured using Resonance Frequency Analysis (RFA) |
Baseline , 1 month & 3 months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |