| CTRI Number |
CTRI/2024/11/076696 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
11/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
How Well Does Injectable Platelet-Rich Fibrin Help in Healing After Dental Implants? A Study on Immediate Implant Placement |
|
Scientific Title of Study
|
Efficacy of injectable platelet rich fibrin in immediate implant placement sites: A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhashini Balaguru |
| Designation |
PG student |
| Affiliation |
SRM kattankulathur dental college |
| Address |
department of periodontology
SRM Kattankulathur dental college
chengalpattu
Chennai
TAMIL NADU
603203
India |
| Phone |
07032371273 |
| Fax |
|
| Email |
sb8143@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.A.V.Saravanan |
| Designation |
Professor |
| Affiliation |
SRM kattankulathur dental college |
| Address |
department of periodontology
SRM kattankulathur dental college and hospital
SRM institute of science and technology
Chennai
TAMIL NADU
624712
India |
| Phone |
9944361464 |
| Fax |
|
| Email |
saravana4@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Subhashini Balaguru |
| Designation |
PG student |
| Affiliation |
SRM kattankulathur dental college |
| Address |
department of periodontology
SRM Kattankulathur dental college
chengalpattu
Chennai
TAMIL NADU
603203
India |
| Phone |
07032371273 |
| Fax |
|
| Email |
sb8143@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM kattankulathur dental college and hospital
chengalpattu-603203
Tamilnadu
India |
| Subhashini
PG student
department of periodontology
SRM kattankulathur dental college and hospital
chengalpattu-603203
Tamilnadu
India |
|
|
Primary Sponsor
|
| Name |
Subhashini Balaguru |
| Address |
93,Naranappanayakkanpatti,chinnakampatti,dindigul,India
pin:624712 |
| 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 subhashini |
SRM kattankulathur dental college and hospital |
fourth floor
Room number 106
department of periodontology
Chennai
TAMIL NADU |
7032371273
sb8143@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
i-PRF with Bone graft |
placement of i-PRF mixed with bone graft in immediate implant placement sites and evaluated after 6 months |
| Comparator Agent |
placement of bone graft |
placement of bone graft alone in immediate implant placement sites and followed up for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 65 years
Good oral hygiene
No acute infection
Root fractures
Grossly decayed roots
Root resorptions
Elians socket classification type I and II
ASA PS I and II |
|
| ExclusionCriteria |
| Details |
Smokers and alcoholics
Pregnant and lactating women
Presence of active infection
Any periapical pathology
Elians socket type III
ASA PS III and above |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
thickness of gingiva
peri-implant probing depth
peri-implant radiolucency
marginal bone level |
6 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
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2024 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sb8143@srmist.edu.in].
- For how long will this data be available start date provided 28-02-2025 and end date provided 19-05-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
purpose of the study is to access the efficacy of injectable platelet rich fibrin in immediate implant placement sites
Brief procedure
Atraumatic tooth extraction will be performed under local anesthesia
Extracted Socket will be assessed for Implant placement
The subjects who fulfill the inclusion criteria will be randomly assigned into following 2 groups using computer generated randomization
GROUP 1 (control group) 10 sites were treated with immediate implant placement with bone graft
GROUP 2(test group) 10 sites were treated with immediate implant placement with injectable platelet rich fibrin mixed with bone graft
The preparation of injectable platelet rich fibrin for the test group will be done by drawing 8 ml intravenous blood from the patient and collected into disposable plastic test tubes
As per Choukroun standard protocol centrifugation at 700rpm for 3min will be done injectable platelet rich fibrin was created at upper level It will be used along with DBM for test group
Both the groups will be assessed for clinical parameters gingival biotype peri implant probing depth and radiographic parameters marginal bone loss peri implant radiolucency at baseline 1 4and 6months follow up |