| CTRI Number |
CTRI/2023/09/057788 [Registered on: 18/09/2023] Trial Registered Prospectively |
| Last Modified On: |
16/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of platelet rich fibrin (derived from blood) on orthodontic treatment duration |
|
Scientific Title of Study
|
EFFICACY OF PLATELET RICH FIBRIN (i-PRF) TO REDUCE
ORTHODONTIC TREATMENT DURATION - 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 |
Dr Sonar Kapil Mahendra |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Division of Orthodontics, Fourth floor, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
07219240637 |
| Fax |
|
| Email |
kms210197@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vilas Duryodhan Samrit |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Division of Orthodontics, Fourth floor, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9899503560 |
| Fax |
|
| Email |
vilassamrit@live.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonar Kapil Mahendra |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Division of Orthodontics, Fourth floor, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi
DELHI
110029
India |
| Phone |
07219240637 |
| Fax |
|
| Email |
kms210197@gmail.com |
|
|
Source of Monetary or Material Support
|
| Division of Orthodontics and Dentofacial Orthopedics, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Sonar Kapil Mahendra |
| Address |
4th Floor, 100A/4, Near Countrywide Apartments, Sudarshan Cinema Road, Gautam Nagar |
| 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 Sonar Kapil Mahendra |
All India Institute of Medical Sciences |
Division of Orthodontics and Dentofacial Deformities, Fourth Floor, Centre for Dental Education and Research, AIIMS, New Delhi 110029
New Delhi
DELHI |
7219240637
kms210197@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injectable Platelet Rich Fibrin (i-PRF) |
Under strict aseptic conditions 10 mL of whole blood will be collected from the medial cubital vein into four vials not containing anticoagulant. 1 mL of the whole blood will be collected separately and sent for the platelet estimation. The blood collected in vials will be centrifuged at 700 rpm for 3 minutes at room temperature. After centrifugation blood will be separated into two layers; Red blood cells at bottom part and yellowish liquid Platelet-rich Fibrin in the upper part. 2-3 mL liquid portion from the upper part will be drawn into disposable insulin syringe and the bottom part containing RBCs will be discarded (35).
INJECTION TECHNIQUE
i-PRF will be injected at two different time points as following.
45
First injection will be given in the attached gingiva of the labial and palatal surface distal to the canine simulating method of infiltration of local anesthesia. Approximately 0.5 mL will be injected in each of the site.
Second injection will be given in the labial attached gingiva in between roots of all six anterior teeth simulating method of infiltration of local anesthesia. Approximately 0.5 mL will be injected in each of the site. |
| Comparator Agent |
No intervention to be done |
No intervention to be done |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1) Age range 15 to 30 years irrespective of gender
2) Class I / half cusp Class II malocclusion cases with moderate to severe crowding in maxillary arch (>6mm calculated by Little’s Irregularity Index)
3) Overbite less than 50%
4) Full permanent dentition from second molar to second molar in both arches
5) Patients without significant medical history
6) Patients with healthy periodontium
7) Patients with positive informed consent |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA
1) Unfavourable/distally tipped canine position
2) Platelet count less than normal 150000 per mcL of blood |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total treatment duration reduction percentage |
1.5 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Levelling and alignment improvement percentage |
1.5 year |
|
|
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)
|
30/09/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/09/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We are doing a randomized controlled trial to evaluate efficacy of injectable platelet rich fibrin in reducing orthodontic treatment duration in Class I moderate to severre crowding patients. The sample size of 20 is divided randomly into two groups, control and intervention. The subjects in intervention group are injected with I-PRF on two time intervals while subjects in control groups are not treated with the same. |