| CTRI Number |
CTRI/2024/04/066015 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
03/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [PRP INJECTION] |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the effect of platelet rich plasma on canine retraction in orthodontic patients. |
|
Scientific Title of Study
|
Comparison Of mini-implant supported maxillary canine retraction with and without submucosal injection of autologous platelet rich plasma :A prospective ,single –blind ,split mouth 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 |
Arushi malhotra |
| Designation |
Postgraduate student |
| Affiliation |
Bhojia Dental college and hospital Bhud , Nalagarh |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Room no: 4,Bhojia Dental College and Hospital, Baddi
Solan
HIMACHAL PRADESH
173205
India |
| Phone |
9814229352 |
| Fax |
|
| Email |
dr.arushimalhotra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sanjay Mittal |
| Designation |
Professor and Head |
| Affiliation |
Bhojia Dental college and hospital Bhud , Nalagarh |
| Address |
Dept of Orthodontics and Dentofacial Orthopedics, Room no:4,Bhojia Dental College and Hospital, Baddi
Solan
HIMACHAL PRADESH
173205
India |
| Phone |
09896050995 |
| Fax |
|
| Email |
sanjaymtdr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Arushi malhotra |
| Designation |
Postgraduate student |
| Affiliation |
Bhojia Dental college and hospital Bhud , Nalagarh |
| Address |
Dept of Orthodontics and Dentofacial Orthopedics, Room no: 4,Bhojia Dental College and Hospital, Baddi
Solan
HIMACHAL PRADESH
173205
India |
| Phone |
9814229352 |
| Fax |
|
| Email |
dr.arushimalhotra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self funding, Dept of Orthodontics and Dentofacial Orthopedics, Room no: 4,Bhojia Dental College and Hospital, Baddi |
|
|
Primary Sponsor
|
| Name |
Arushi Malhotra |
| Address |
Bhojia Dental College and Hospital, Budh, Baddi |
| 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 Arushi Malhotra |
Bhojia Dental College and Hospital Bhud ,Baddi. |
Dept of Orthodontics and Dentofacial Orthopedics, Room no:4,Bhojia Dental College and Hospital, Baddi
Solan
HIMACHAL PRADESH |
09814229352
dr.arushimalhotra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Bhojia Dental College & Hospital, Bhud, Himachal Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
MEDICALLY FIT |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Not applicable | (Procedure Reference: , Procedure details: )
|
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Age range 16-25 years
Critical anchorage
Adequate interradicular distance between the maxillary first permanent molar and second premolar for insertion of mini screws.
Good gingival and periodontal health (probing depth ≤3mm,gingival index score ≤1).
No systemic disease
Full development of teeth except 3rdmolars.
Patients requiring bilateral extraction of maxillary 1st premolar as part of their comprehensive treatment.
Platelet count above 100000/mL.
|
|
| ExclusionCriteria |
| Details |
Clotting or bleeding disorders.
Smokers, alcoholism
Pregnancy
Systemic disease or medications intake that interfere with orthodontic tooth movement or platelet count.
Sign and symptom of periodontal disease.
Gingival inflammation. (gingivitis)
Poor oral hygiene for ≥ 2 visits.
History of previous orthodontic treatment.
Dental caries.
Long term use of antibiotics,phenytoin, cyclosporine,anti-inflammatory drugs, systemic corticosteroids and calcium channel blockers.
Crossbite or deviation during jaw closure caused by occlusal interferences.
Patient with severe tooth displacement (eg ectopic canine)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The predictor variable is the canine retraction technique i.e canine retraction with and without PRP injection. The canine retraction rate is our primary outcome. |
Base time point T0, then every monthly time point till four months i.e. T1, T2, T3, T4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Canine Rotations & molar rotations will be measured at monthly time intervals till 4 months from the base time point |
base time point T0, then monthly intervals T1, T2, T3 & T4 |
| Pain scores will be measured on VAS at base point, at 24 hours & after 7 days |
base point, at 24 hours , after 7 days |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
26/04/2024 |
| 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="1"
Months="0"
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 - All of the individual participant data collected during the trial, after de-identification.
- 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 who provide a methodologically sound proposal.
- 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 [dr.arushimalhotra@gmail.com].
- For how long will this data be available start date provided 26-03-2024 and end date provided 26-03-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study is a Prospective ,Single-blind ,Randomized controlled trial with a Split-mouth design to evaluate the efficacy of submucosal injection of platelet rich plasma (PRP) for accelerating orthodontic tooth movement (OTM) in fixed orthodontic patients . The study will be conducted at the Department of orthodontics and dentofacial Orthopaedics (Bhojia dental collage and hospital ,Baddi). The study population will include subjects with permanent dentition of either gender between 16 and 25 years of age requiring bilateral extraction of maxillary first permanent molar as part of their comprehensive treatment. The inclusion criteria also specify critical anchorage ,adequate inter-radicular distance between maxillary first permanent molar and second premolar for insertion of mini screws , and good gingival and periodontal health . The intervention involves the application of fixed orthodontic brackets and extraction of maxillary first premolars for all patients. The principal investigator will be responsible for examining the subjects and determining their eligibility . The trial coordinator will evaluate the rate of canine retraction , and the follow-up process will involve assessing the subjects and analyzing the data. The study will be conducted according to the 1975 Helsinki declaration guidelines as revised in 2013 . statistical analysis will be done with SPSS version 22.0. |