| CTRI Number |
CTRI/2018/03/012316 [Registered on: 05/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
01/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to test the efficacy of low level laser application on the rate of orthodontic tooth movement |
|
Scientific Title of Study
|
A clinically controlled trial to test the efficacy of low level laser application on the rate of orthodontic tooth movement |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rythm Kharbanda |
| Designation |
Pg Second year MDS |
| Affiliation |
Subharti Dental College |
| Address |
5O- Shiv Vihar new avas vikas ,Saharanpur, U.P
Rani durgawatti girls hostel, subharti university, Meerut
Meerut
UTTAR PRADESH
247001
India |
| Phone |
7895554340 |
| Fax |
|
| Email |
rythmkharbanda@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Raghav |
| Designation |
Head of the department of Orthodontics |
| Affiliation |
Swami Vivekanand Subharti University |
| Address |
Subharti Dental College, Meerut
Subharti Dental College
Meerut
UTTAR PRADESH
250001
India |
| Phone |
9837175914 |
| Fax |
|
| Email |
drpradeepraghav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rythm Kharbanda |
| Designation |
pg second year MDS |
| Affiliation |
Swami Vivekanand Subharti University |
| Address |
50 shiv vihar near avas vikas saharanpur
subharti dental college
Meerut
UTTAR PRADESH
247001
India |
| Phone |
7895554340 |
| Fax |
|
| Email |
rythmkharbanda@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rythm Kharbanda |
| Address |
Department of orthodontics, Subharti Dental College |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| DrRythm Kharbanda |
Department of orthodontics and Dentofacial Orthopedics |
Subharti dental college
Swami vivekanand subharti university
Meerut
UTTAR PRADESH |
7895554340
rythmkharbanda@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Approved byInstitution of Ethical Committee, Subharti Dental College, Swami Vivekanand Subharti University. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
No systemic disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low level laser therapy |
The study design would be Split mouth technique. Semi conductor diode laser ( Ga Al As) of wavelength 980nm at power of 0.1W in 15 samples and 0.02W in another 15 samples, for time duration of 10 seconds will be applied to the patients in contact with mucosa and in continuous mode. Laser application will be done after the leveling and alignment will be completed. Irradiations will be given in the canine region on the cervical 1/3rd, middle 1/3rd and apical 1/3rd on the experimental side and on the control side light cure unit will be applied. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria-
• Age range-15-25 years
• Both male and female will be included
• No systemic disease
• Bilateral premolar extraction
• No radiographic bone loss
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria-
• Overjet> 10mm
• Bone disease
• Extreme skeletal Class II malocclusion
• Systemic use of corticosteroids.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in the rate of tooth movement on the experimental side. |
4-6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to measure the amount of tooth movement |
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
12/02/2018 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
yet to publish |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study is clinically controlled trial to test the efficacy of rate of tooth movement on application of low level laser therapy. The study design would be Split mouth technique. Semi conductor diode laser ( Ga Al As) of wavelength 980nm at power of 0.1W in 15 samples and 0.02W in another 15 samples, for time duration of 10 seconds will be applied to the patients in contact with mucosa and in continuous mode. Laser application will be done after the leveling and alignment will be completed. Irradiations will be given in the canine region on the cervical 1/3rd, middle 1/3rd and apical 1/3rd on the experimental side and on the control side light cure unit will be applied. |