| CTRI Number |
CTRI/2026/04/107747 [Registered on: 07/04/2026] Trial Registered Prospectively |
| Last Modified On: |
06/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate Bone Healing and Stability of Dental Implants With and Without Bone Regenerative Liquid.” |
|
Scientific Title of Study
|
Evaluation of the Effect of Bone Bioactive Liquid on Osseointegration A Randomised Control Trial Assessing Primary 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 Dental College and Hospitals |
| 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
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
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 Dental College and Hospitals |
| 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
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
Chennai
TAMIL NADU
600116
India |
| Phone |
9353451968 |
| Fax |
|
| Email |
d0323001@sriher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr A R Sowmya Ranjana |
| Designation |
Postgraduate |
| Affiliation |
Sri Ramachandra Dental College and Hospitals |
| 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
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
Chennai
TAMIL NADU
600116
India |
| Phone |
9353451968 |
| Fax |
|
| Email |
d0323001@sriher.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr A R Sowmya Ranjana |
| Address |
Plot no 161, SF1, Moms nest , maduram nagar second street , periyakolathuvancheri , iyyapanthangal, chennai- 600121 |
| Type of Sponsor |
Other [other ] |
|
|
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
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 commitee |
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. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bone Bioactive Liquid ( Theravex) |
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 without BBL application (ie)untreated implants |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| 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 |
Bone Turn over Markers
|
Baseline , 1 month and 3 months post implantation |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
25/04/2026 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 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 |