| CTRI Number |
CTRI/2023/08/056520 [Registered on: 16/08/2023] Trial Registered Prospectively |
| Last Modified On: |
18/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Tooth replacement by Implants & Blood Platelets substitutes |
|
Scientific Title of Study
|
Clinical and Radiographic evaluation of Implant Stability and crestal bone levels of dental implants with and without injectable Platelet Rich Fibrin
(i-PRF) – A Randomized Control Study |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Kasukurthi Komali |
| Designation |
Post Graduate Student |
| Affiliation |
Kamineni Institute of Dental Sciences |
| Address |
Kamineni Institute of Dental Sciences
Department Of Periodontics
Narketpally
Nalgonda Dist.
TELANGANA
INDIA
Nalgonda
TELANGANA
508 254
India |
| Phone |
9591212165 |
| Fax |
|
| Email |
komalikasukurthi19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suryakanth Malgikar |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor Kamineni Institute of Dental Sciences |
| Address |
Kamineni Institute Of Dental Sciences
Department Of Periodontics
Narketpally
Nalgonda Dist.
TELANGANA
INDIA
Nalgonda
TELANGANA
508 254
India |
| Phone |
9591212165 |
| Fax |
|
| Email |
drmalgikarsuryakanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Kasukurthi Komali |
| Designation |
Post Graduate Student |
| Affiliation |
Kamineni Institute of Dental Sciences |
| Address |
Kamineni Institute Of Dental Sciences
Department Of Periodontics
Narketpally
Nalgonda Dist.
TELANGANA
INDIA
Nalgonda
TELANGANA
508 254
India |
| Phone |
9591212165 |
| Fax |
|
| Email |
komalikasukurthi19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kamineni Institute of Dental Sciences
individuals from out-patient section department of periodontics kamineni institute of dental sciences nalgonda district telangana |
|
|
Primary Sponsor
|
| Name |
Dr Komali Kasukurthi |
| Address |
Kamineni Institute of Dental Sciences
Narketpally
Nalgonda District |
| Type of Sponsor |
Other [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 Komali Kasukurthi |
Kamineni Institute of Dental Sciences |
Department of Periodontics
Sreepuram
Narketpally
Nalgonda District
Nalgonda
TELANGANA |
9491511968
komalikasukurthi19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAMINENI INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
injectable platelets rich fibrin |
aim of the present study is to evaluate and compare the implant stability and radiographic crestal bone levels of dental implants coated with & without injectable platelet rich fibrin (i-PRF) at baseline and 3 months |
| Intervention |
Placebo |
baseline and 3 months
Controls are treated with out injectable platelets rich fibrin then primary stability and crestal bone levels of implant will be measured at baseline and 3 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age group 20 - 60 years.
2. Patients with single edentulous sites in either jaw.
3. Absence of restoration/prosthesis adjacent to edentulous site.
4. Healed extraction socket site ≥ 3 months.
|
|
| ExclusionCriteria |
| Details |
1. Patients with systemic diseases.
2. Smokers.
3. Pregnant or lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Implant Stability And Crestal Bone Levels |
Base line &
3 MONTHS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 3 |
|
Date of First Enrollment (India)
|
26/08/2023 |
| 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="6"
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
Modification(s)
|
| NEED FOR THE STUDY: Successful osseointegration is the first step in long-term survival and stability of a dental implant. Surface modifications by implant manufacturers are aimed at improving the bone-implant contact and another technique for improving the bone-implant contact and reducing osseointegration time could be represented by the use of autologous blood derivatives that contain a rich supply of growth factors and bone-specific proteins.1 Injectable platelet-rich fibrin (i-PRF) is the most recent and successful advancement in PRF and is beneficial for bone augmentation of the alveolar ridge prior to or during implant placement and wound healing.2 Use of i-PRF as a surface coating performed as a chairside procedure to coat the surface of the implant just prior to placement can be implemented to improve osseointegration. It could possibly serve as a simple, economical, and effective way of ensuring better implants success and quicker treatment time. As it is in a liquid formulation, it can be evenly applied all over the implant surface.1 The scientific data regarding the i-prf coated implants is inadequate. Hence, the present study is designed to evaluate and compare implants with and without i-PRF coating. SURFACE COATING OF IMPLANT WITH i-PRF: Ø The osteotomy sites will be prepared using standard sequential drilling protocol for the full sequence. Ø Just before implant placement the i-PRF will be prepared. Ø For i-PRF preparation,10 ml of whole blood without anticoagulant will be centrifuged at 700 rpm for 3 min at room temperature. 3 Ø After 3 mins the straw-colored liquid present at the top which is i-PRF will be collected. Ø 1.5 ml of i-PRF liquid will be used to coat the implants by dipping in i-PRF. RESEARCH QUESTION - Does implant with i-PRF will have better implant stability and crestal bone levels when compared to implants without i-PRF? RESEARCH HYPOTHESIS [H1] - Implant with i-PRF may have better implant stability and crestal bone levels when compared to implants without i-PRF. | |