| CTRI Number |
CTRI/2023/08/056931 [Registered on: 25/08/2023] Trial Registered Prospectively |
| Last Modified On: |
09/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical research to study the root resorption by estimating the levels of biomarker in the saliva and X- ray in patients undergoing fixed orthodontic therapy after injection of blood component(i-PRF) to fasten the orthodontic tooth movement. |
|
Scientific Title of Study
|
Evaluation of the effect of injectable platelet rich fibrin (i-PRF) on root resorption in patients undergoing fixed orthodontic therapy: a biochemical and CBCT analysis - a randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr JN Rupa |
| Designation |
junior resident |
| Affiliation |
centre for dental education and research |
| Address |
4th floor, AIIMS-CDER Ln, Block D2, Ansari Nagar East
South
DELHI
110029
India |
| Phone |
8971770265 |
| Fax |
|
| Email |
rupajn123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vilas Samrit |
| Designation |
Associate Professor |
| Affiliation |
centre for dental education and research |
| Address |
4th floor, AIIMS-CDER Ln, Block D2, Ansari Nagar East
South
DELHI
110029
India |
| Phone |
9899503560 |
| Fax |
|
| Email |
vilassamrit@live.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr JN Rupa |
| Designation |
junior resident |
| Affiliation |
centre for dental education and research |
| Address |
4th floor, AIIMS-CDER Ln, Block D2, Ansari Nagar East
4th floor, AIIMS-CDER Ln, Block D2, Ansari Nagar East
South
DELHI
110029
India |
| Phone |
8971770265 |
| Fax |
|
| Email |
rupajn123@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr JN Rupa |
| Address |
CDER 4th floor, AIIMS , Block D2 ,Ansari Nagar East, New Delhi 110029 |
| 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 JN Rupa |
AIIMS NEW DELHI |
CDER division of orthodontics and dentofacial deformities, 4th floor, room no. 415
South
DELHI |
8971770265
rupajn123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K002||Abnormalities of size and form ofteeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Preadjusted Edgewise Appliance with i PRF
|
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.i-PRF will be injected 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.Fixed orthodontic appliance is bonded in patients from both groups using Preadjusted edgewise brackets system MBT prescription with 0.022 × 0.028-inch slot size. |
| Comparator Agent |
preadjusted edgewise appliance without i PRF |
Fixed orthodontic appliance is bonded in patients from both groups using Preadjusted edgewise brackets system MBT prescription with 0.022 × 0.028-inch slot size. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
patient with Class I / half cusp Class II malocclusion cases with moderate to severe crowding in maxillary arch (>6mm Little’s Irregularity Index).No previously reported or observed active orthodontic treatment. Completed root apexification assessed with periapical radiographs. Patients with healthy periodontium and no gingival inflammation at the experimental sites. Patients with positive informed consent.
|
|
| ExclusionCriteria |
| Details |
patient with Platelet count less than normal 150000 per µl of blood. Patients on regular antibiotics, steroids or anti-inflammatory drugs. Signs of external apical root shortening observed at the preoperative radiographic examination.
Non- compliant patient with poor oral hygiene.
Syndromic patients |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Estimate and compare levels of DSPP in GCF at different interval of time during alignment of maxillary incisors with and without i-PRF injection. |
preoperative, before anterior alignment, 4 weeks, 8 weeks,3 month, 4 month, 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To estimate the amount and extent of root resorption in the maxillary incisors after alignment with and without i-PRF injection using CBCT. |
preoperative and postoperative |
|
|
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)
|
01/10/2023 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
External
root resorption is a common unfavorable side effect of orthodontic treatment.
In orthodontic treatment approaches, the magnitude, duration, and type of
orthodontic force application are important considerations. The maxillary
lateral incisor had the highest root resorption, followed by the maxillary
central incisor. The severity of root
resorption may be related to greater tooth mobility after orthodontic
treatment. i-PRF is the second generation of platelet concentrates, and it has
the advantage of gradually releasing growth factors over time. According to
current research, i-PRF accelerates tooth movement. There was no gold
standard for detecting and evaluating orthodontically caused root resorption
(OIRR). Traditional radiography may not be sensitive enough to detect
root resorption in its early phases; however, evaluating root resorption
biomarkers in GCF has been shown to be a safe and accurate alternative to
diagnosing and monitoring OIRR. |