| CTRI Number |
CTRI/2026/01/100911 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Combined effect of locally injected Vitamin D3 and injectable platelet rich fibrin which is a blood derivative on the rate of tooth movement during comprehensive orthodontic treatment in adult patients and expression of various biomarkers present in gingival crevicular fluid |
|
Scientific Title of Study
|
Synergistic Effect of Locally Injected Vitamin D3 and Injectable Platelet Rich Fibrin (i-PRF) on the Rate of Maxillary Canine Retraction, and Expression of Various Biomarkers in Gingival Crevicular Fluid (GCF) During Comprehensive Orthodontic Treatment: A Randomized Split Mouth Comparative 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 |
SITHARA T SAJI |
| Designation |
JUNIOR RESIDENT ACADEMIC |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
First floor, department of dentistry
AIIMS BHUBANESWAR
SIJUA
PATRAPADA
ODISHA
751019
AIIMS BHUBANESWAR
SIJUA
PATRAPADA
ODISHA
751019
Khordha
ORISSA
751019
India |
| Phone |
7909158201 |
| Fax |
|
| Email |
sajisithara1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
JITENDRA SHARAN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
1ST FLOOR, DEPARTMENT OF DENTISTRY, AIIMS, SIJUA, PATRAPADA, PO: DUMDUMA, BHUBANESWAR, ORISSA-751019
Khordha
ORISSA
751019
India |
| Phone |
9968856761 |
| Fax |
|
| Email |
dent_jitendra@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
JITENDRA SHARAN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
1ST FLOOR, DEPARTMENT OF DENTISTRY, AIIMS, SIJUA, PATRAPADA, PO: DUMDUMA, BHUBANESWAR, ORISSA-751019
Khordha
ORISSA
751019
India |
| Phone |
9968856761 |
| Fax |
|
| Email |
dent_jitendra@aiimsbhubaneswar.edu.in |
|
|
Source of Monetary or Material Support
|
| Self funded by principal investigator |
|
|
Primary Sponsor
|
| Name |
SITHARA T SAJI |
| Address |
1ST FLOOR, DEPARTMNENT OF DENTISTRY, AIIMS, SIJUA, PATRAPADA, PO:DUMDUMA, BHUBANESWAR, ORISSA-751019 |
| 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 |
| SITHARA T SAJI |
AIIMS BHUBANESWAR |
1ST FLOOR, DEPARTMENT OF DENTISTRY, AIIMS, SIJUA, PATRAPADA, PO:DUMDUMA, BHUBANESWAR, ORISSA-751019
Khordha
ORISSA |
7909158201
sajisithara1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE, AIIMS BHUBANESWAR |
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: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
i-prf and saline |
i-PRF will be injected around the canine at each of three sites buccally, distally and palatally (0.2 ml each) |
| Intervention |
i-prf and vitamin D injection
|
Injecting vitamin D 1ml at two points buccally along the distal margin of the root of canine, 1cm above the CEJ and at the buccal vestibule.
1ml at two points palatally, 1cm above the CEJ and at the intersection of horizontal and vertical planes of palate.
0.6 ml of i-PRF will be injected around the canine at each of three sites buccally, distally and palatally (0.2 ml each)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Class I bimaxillary dentoalveolar protrusion or Class II div 1 malocclusion and minimum crowding and spacing, either all 1st premolars or only upper 1st premolars extraction.
Presence of full complement of teeth in the maxillary arch except 3rd molars.
Good oral hygiene |
|
| ExclusionCriteria |
| Details |
Patients who are not willing to participate in the study, History of complete or incomplete comprehensive orthodontic treatment, Subject who fails to maintain adequate oral hygiene all through the orthodontic treatment, Subjects with pregnancy, Subjects having any known syndrome or metabolic disorder affecting calcium and
phosphate metabolism, Subjects on long-term medication like NSAID’S or steroids, Lack of manual dexterity. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To estimate the synergistic effects of localized Vitamin D and i-PRF injections on the
rate of maxillary canine retraction during comprehensive orthodontic treatment |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To evaluate the effects of Vitamin D3 & i-PRF injection on the concentration of
various biomarkers in GCF during comprehensive orthodontic tooth movement
2)To correlate the rate of canine retraction with the concentrations of biomarkers in GCF
(RANKL & OPG) following the injection of vitamin D3 & i-PRF |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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 2 |
|
Date of First Enrollment (India)
|
30/01/2026 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Long duration of orthodontic treatment is a major
problem in adult patients. Thus Orthodontic
professionals are constantly looking for ways to
accelerate orthodontic tooth movement thereby reducing
the treatment duration. Adults show lagging cell
mobilization rates, irregular arrangement of collagen
fibers, and are more prone for periodontal diseases in
comparison to the younger patients. Therefore,
shortening the duration of treatment by hastening the
tooth movement is challenging for orthodontists.
There are number of techniques available to
augment the rate of orthodontic tooth movement and they
can be invasive or non-invasive. Presently, Vitamin D
and i-PRF are used for the process of bone remodeling.
There are limited studies in literature mentioning
benefits of i-PRF and Vitamin D on the acceleration of
orthodontic tooth movement. The benefits of i-PRF and
Vitamin D remains for a period of 4 weeks and 2 weeks
8 respectively. The combined use of i-PRF and Vitamin D
can be beneficial for the orthodontic tooth movement.
There is no study in the literature mentioning the
synergistic effects of i-PRF and Vitamin D on
orthodontic tooth movement. Hence the current study is
planned to evaluate the synergistic effects of i-PRF and
Vitamin D on the rate of orthodontic tooth movement
and to correlate the same with the expression of various
biomarkers in GCF during comprehensive orthodontic
treatment. |