| CTRI Number |
CTRI/2021/01/030225 [Registered on: 04/01/2021] Trial Registered Prospectively |
| Last Modified On: |
09/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of two different laser wavelength on orthodontic tooth movement |
|
Scientific Title of Study
|
Analyzing the effect of LLLT using two different laser wavelengths on the rate of Canine Retraction and expression of Interleukin-1β in GCF: A split mouth 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 |
Vipul Jain |
| Designation |
RESIDENT |
| Affiliation |
INDIAN ARMY |
| Address |
Department of Orthodontics, Army Dental Centre R and R, Army Hospital R and R, Dhaula Kuan, New Delhi
South West
DELHI
110010
India |
| Phone |
08527936991 |
| Fax |
|
| Email |
dr.vipuljain001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Brig Balakrishnan Jayan |
| Designation |
Commandant, Professor and HOD |
| Affiliation |
INDIAN ARMY |
| Address |
Department of Orthodontics, Army Dental Centre R and R, Dhaula Kuan, New Delhi
South West
DELHI
110010
India |
| Phone |
7042811021 |
| Fax |
|
| Email |
bjayan66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vipul Jain |
| Designation |
RESIDENT DOCTOR |
| Affiliation |
INDIAN ARMY |
| Address |
Department of Orthodontics, Army Dental Centre R and R, Army Hospital, R and R, Dhaula Kuan, New Delhi
South West
DELHI
110010
India |
| Phone |
08527936991 |
| Fax |
|
| Email |
dr.vipuljain001@gmail.com |
|
|
Source of Monetary or Material Support
|
| OFFICE OF DIRECTOR GENERAL DENTAL SERVICES, DELHI 01 |
|
|
Primary Sponsor
|
| Name |
OFFICE OF DIRECTOR GENERAL DENTAL SERVICES |
| Address |
L BLOCK, INTEGRATED HEADQUARTERS OF ARMY, MINISTRY OF DEFENCE, SOUTH BLOCK |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| VIPUL JAIN |
Army Dental Centre R and R, Army Hospital R and R, Dhaula Kuan |
2nd floor, C Wing, Department of Orthodontics and Dentofacial Orthopaedics
South West
DELHI |
08527936991
dr.vipuljain001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ARMY DENTAL CENTRE ARMY HOSPITAL RESEARCH REFERRAL NEW DELHI |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
660nm WAVELENGTH LASER |
660nm WAVELENGTH LOW LEVEL LASER WILL BE DELIVERED AT 500mW USING HELBO LASER for 10 seconds at monthly interval at ten points on canine (five points on buccal and five on palatal surface..... five points includes one point each on mesial and distal of alveolar crest, one at mid root and two at root apex |
| Intervention |
980nm WAVELENGTH LASER RADIATION |
980nm WAVELENGTH LOW LEVEL LASER WILL BE DELIVERED AT 500mW USING DIODE LASER MACHINE at monthly interval at 0.5 W for 10 seconds at ten points on canine (five points on buccal and five on palatal surface..... five points includes one point each on mesial and distal of alveolar crest, one at mid root and two at root apex level) |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS REQUIRING BILATERAL EXTRACTION OF MAXILLARY FIRST PREMOLARS FOR ORTHODONTIC TREATMENT |
|
| ExclusionCriteria |
| Details |
PATIENTS REQUIRING ORTHOGNATHIC SURGERY
PATIENTS WITH SMOKING HABITS
PATIENTS WITH DEBILITATING SYSTEMIC DISEASES |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| RATE OF CANINE RETRACTION |
RATE OF CANINE RETRACTION AT FIRST DAY AND FOUR WEEKS AND EIGHT WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| INTERLEUKIN 1 BETA LEVELS |
INTERLEUKIN 1 BETA LEVELS AT FIRST DAY AND FOUR WEEKS AND EIGHT WEEKS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/01/2021 |
| Date of Study Completion (India) |
24/06/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Trial will be done to evaluate and analyze the effect of low-level laser therapy using two different wavelengths on the rate of maxillary canine retraction, change in expression of Interleukin 1β in the gingival crevicular fluid with the two wavelengths and to determine the accelerated tooth movement with Low Level Laser Therapy. Group 1 will be evaluated for the effect of 980 nm wavelength Low Level Laser Therapy on the rate of canine retraction as compared to conventional technique. Group 2 will be evaluated for the effect of 660 nm wavelength Low Level Laser Therapy on the rate of canine retraction as compared to conventional technique. Group 3 will be evaluated for the effect of 980 nm wavelength Low Level Laser Therapy on the rate of canine retraction with respect to 660 nm wavelength Low Level Laser Therapy. Also the expression of Interleukin 1β (Biomarker) from the gingival crevicular fluid isolated from the irradiated and non-irradiated canines will be assessed in all groups. |