| CTRI Number |
CTRI/2025/07/090179 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Testing Special Implants That Help Bones Grow and Heal Faster |
|
Scientific Title of Study
|
Assessing Osteogenic Activity in Injectable Platelet Rich Fibrin Coated Implants Using Bone-specific Alkaline Phosphatase Biomarker An Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhavya Agarwal |
| Designation |
Junior Resident |
| Affiliation |
Institute of Dental Sciences Bareilly |
| Address |
Room number 228 Department of Periodontics Institute of Dental Sciences
Bareilly
Room number 223 Department of Periodontics Institute of Dental Sciences
Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9634953202 |
| Fax |
|
| Email |
bhavyaagarwal16oct@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rika Singh |
| Designation |
Professor and Head |
| Affiliation |
Institute of Dental Sciences Bareilly |
| Address |
Room number 228 Department of Periodontics Institute of Dental Sciences
Bareilly
Room number 223 Department of Periodontics Institute of Dental Sciences
Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9458411133 |
| Fax |
|
| Email |
rikasingh22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rika Singh |
| Designation |
Professor and Head |
| Affiliation |
Institute of Dental Sciences Bareilly |
| Address |
Room number 228 Department of Periodontics Institute of Dental Sciences
Bareilly
Room number 223 Department of Periodontics Institute of Dental Sciences
Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9458411133 |
| Fax |
|
| Email |
rikasingh22@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute of Dental Sciences Bareilly |
| Address |
Room number 228 Department of Periodontics Institute of Dental Sciences Bareilly Suresh Sharma Nagar, Pilibhit Bypass Road Bareilly 243006 |
| Type of Sponsor |
Other [Institute of Dental Sciences Bareilly] |
|
|
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 Bhavya Agarwal |
Institute of Dental Sciences Bareilly |
Room 228 Department of Periodontics
Bareilly
UTTAR PRADESH |
9634953202
bhavyaagarwal16oct@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IDS Bareilly UP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
IPRF |
Injectable Platelet Rich Fibrin (i-PRF), is prepared through centrifugation at 700 rpm for 3 minutes, without addition of any anticoagulant. |
| Comparator Agent |
Without any coating |
Dental Implant will be placed without any coating |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Sufficient bone width and height available for placement of implant Adequate oral hygiene maintenance
|
|
| ExclusionCriteria |
| Details |
Presence of active periodontal disease
History of smoking or tobacco consumption
Pregnant & lactating females
Patient with bone related disorders
Patients on medication like bisphosphonates calcium supplements
Patient with psychiatric disorders
Uncontrolled bleeding disorders
Uncontrolled systemic diseases |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the levels of BALP in PISF of implants coated with i-PRF
To evaluate the levels of BALP in PISF of implants without i-PRF coating
To inter-compare the levels of BALP in PISF of implants with and without i-PRF coating at 2, 4 and 8 weeks of implant placement
|
2, 4 and 8 weeks after implant placement
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the levels of BALP in PISF of implants coated with i-PRF |
2, 4 and 8 weeks after implant placement |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/07/2025 |
| 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="1"
Months="0"
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
|
This observational study will aim to evaluate the osteogenic potential of dental implants coated with injectable Platelet-Rich Fibrin (i-PRF) by assessing levels of Bone-specific Alkaline Phosphatase (BALP), a biomarker indicative of bone formation activity.
A total of 28 systemically healthy patients, aged between 20 and 65 years and requiring implant placement, will be selected and randomly divided into two groups:
All implant procedures will be performed following standard surgical protocols. Peri-implant sulcular fluid (PISF) will be collected from each patient at 2, 4, and 8 weeks following implant placement. The levels of BALP in these samples will be analyzed using an enzyme-linked immunosorbent assay (ELISA) to compare osteogenic activity between the coated and uncoated implant groups.
The application of i-PRF, an autologous blood derivative rich in growth factors, is expected to enhance early osseointegration by promoting osteoblastic activity and bone formation. This study will aim to provide further insight into the clinical advantages of bioactive surface coatings in improving implant success and reducing healing time.
Statistical analysis will be performed using SPSS v21.0 to determine any significant differences in BALP levels across time intervals and between the two groups. |