| CTRI Number |
CTRI/2024/10/075788 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To understand how the fast the duration of braces treatment will take place with either of two intervention: A platelet rich plasma injection and a low-level laser therapy |
|
Scientific Title of Study
|
Effectiveness of Platelet-rich plasma and Low-level laser therapy in accelerating orthodontic tooth movement :A split mouth-Clinical 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 |
Dr Harshali Zavar |
| Designation |
MDS 1st year |
| Affiliation |
School of Dental Sciences Krishna Institute of Medical Sciences Maharashtra |
| Address |
School of Dental Sciences, KVV, Malkapur, Karad
Department of Orthodontics and Dentofacial Orthopedics
School of Dental Sciences, KVV, Malkapur, Karad
Department of Orthodontics and Dentofacial Orthopedics
Satara
MAHARASHTRA
415539
India |
| Phone |
08805478250 |
| Fax |
|
| Email |
harshalizavar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Channamallappa R Ganiger |
| Designation |
Professor and head of department |
| Affiliation |
School of Dental Sciences Krishna Institute of Medical Sciences Maharashtra |
| Address |
School of Dental Sciences, KVV, Malkapur, Karad
Department of Orthodontics and Dentofacial Orthopedics
School of Dental Sciences, KVV, Malkapur, Karad
Department of Orthodontics and Dentofacial Orthopedics
Satara
MAHARASHTRA
415539
India |
| Phone |
09986841519 |
| Fax |
|
| Email |
channapparganiger@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshali Zavar |
| Designation |
MDS 1st year |
| Affiliation |
School of Dental Sciences Krishna Institute of Medical Sciences Maharashtra |
| Address |
School of Dental Sciences, KVV, Malkapur, Karad
Department of Orthodontics and Dentofacial Orthopedics
School of Dental Sciences, KVV, Malkapur, Karad
Department of Orthodontics and Dentofacial Orthopedics
Satara
MAHARASHTRA
415539
India |
| Phone |
8805478250 |
| Fax |
|
| Email |
harshalizavar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Krishna Vishwa Vidyapeeth deemed to be university
Karad, District- Satara, State- Maharashtra, Pincode- 415539, Country- India |
|
|
Primary Sponsor
|
| Name |
Krishna Vishwa Vidhyapeeth School of dental sciences |
| Address |
Krishna Vishwa Vidyapeeth, School of dental sciences, Malkapur, Karad, Satara, Maharashtra, India
Pincode- 415539 |
| Type of Sponsor |
Private medical college |
|
|
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 Harshali Zavar |
School of dental sciences, Krishna Vishwa Vidyapeeth |
Department of Orthoodntics and dentofacial orthopedics, KVV, department no- 41
Satara
MAHARASHTRA |
08805478250
harshalizavar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Krishna Vishwa Vidyapeeth Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals with dental malocclusion who wants to undergo orthodontic treatment
Healthy individuals without any systemic conditions
healthy individuals not taking any medications
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
low level laser therapy |
Novolase photobiomodulation laser therapy is given to the indivdual participating in the study at the canine tooth
Laser therapy will be given at every 4 week duartion for 2 months |
| Comparator Agent |
plain saline solution |
normal saline solution is given to the other side of both the intervention group |
| Intervention |
Platelet rich plasma |
platelet rich plasma is freshly prepared from the blood of the participant in the study and administered single dose 0.5 ml in the labial vestibule of oral cavity near canine tooth at 1st week. The effect of the injection is for a duration of 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Patients having permanent dentition. Patients with Class 1 malocclusion with bimaxillary protrusion, Class II division I malocclusion, mild crowding in the range of 2-4 mm, and were indicated for maxillary first premolar extraction and bilaterally maxillary canine distalization. Age: Patients in the age group of 16-35 years of age.
|
|
| ExclusionCriteria |
| Details |
Patients with poor oral hygiene. Patients with impacted canines. Patients with recent major illness resulting in reduced platelet count. Patients on regular antibiotics, steroids, or anti-inflammatory drugs.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accelerated tooth movement |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain assessment |
3 months |
| root resorption of canine tooth |
3 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/11/2024 |
| Date of Study Completion (India) |
24/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This is a split-mouth randomised clinical study; each sample receives platelet-rich plasma and low-level laser therapy on randomly assigned side of participants mouth as an intervention. Each group is under observation for a period of 3 months where the rate of orthodontic tooth movement is studied by taking impressions at a regular interval at start of canine retraction, 4th week and 8th week. pain assessment and root resorption is also studied over a period of 3 months. |