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CTRI Number  CTRI/2022/08/044842 [Registered on: 23/08/2022] Trial Registered Prospectively
Last Modified On: 18/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Low level Laser , Vibration Stimulation used in orthodontics]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   TO assess the effect of vibration and low level laser therapy on the amount of IL1- Beta, IL-8 and orthodontic tooth movement 
Scientific Title of Study   To evaluate the effect of vibratory stimulation and low level laser therapy on the levels of Interlukin-1 Beta, Interlukin-8 and amount of 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 Aastha Purohit 
Designation  Post Graduate Student 
Affiliation  Inderprastha Dental College and Hospital, Uttar Pradesh 
Address  Third Floor. Room number 2, Department of Orthodontics and Dentofacial Orthopaedics, Inderprastha Dental College and Hospital, 46/1 Site 4 Industrial Area Sahibabad Ghaziabad Uttar Pradesh
Flat no 102, plot no. 66, Near Gate no 4 Ramprastha Greens, Vaishali Extension, 201014
Ghaziabad
UTTAR PRADESH
201010
India 
Phone  09454889318  
Fax    
Email  aastha1994purohit@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aastha Purohit 
Designation  Post Graduate Student 
Affiliation  Inderprastha Dental College and Hospital, Uttar Pradesh 
Address  Third Floor. Room number 2, Department of Orthodontics and Dentofacial Orthopaedics, Inderprastha Dental College and Hospital, 46/1 Site 4 Industrial Area Sahibabad Ghaziabad Uttar Pradesh
Flat no 102, plot no. 66, Near Gate no 4 Ramprastha Greens, Vaishali Extension, 201014
Ghaziabad
UTTAR PRADESH
201010
India 
Phone  09454889318  
Fax    
Email  aastha1994purohit@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aastha Purohit 
Designation  Post Graduate Student 
Affiliation  Inderprastha Dental College and Hospital, Uttar Pradesh 
Address  Third Floor. Room number 2, Department of Orthodontics and Dentofacial Orthopaedics, Inderprastha Dental College and Hospital, 46/1 Site 4 Industrial Area Sahibabad Ghaziabad Uttar Pradesh
Flat no 102, plot no. 66, Near Gate no 4 Ramprastha Greens, Vaishali Extension, 201014
Ghaziabad
UTTAR PRADESH
201010
India 
Phone  09454889318  
Fax    
Email  aastha1994purohit@gmail.com  
 
Source of Monetary or Material Support  
Name- Dr Aastha Purohit (self) Address- Third Floor Room number 2, Department of Orthodontics and Dentofacial Orthopaedics, Inderprastha Dental College and Hospital,46/1 Site 4 Industrial Area Sahibabad Ghaziabad Uttar Pradesh, 201010. 
 
Primary Sponsor  
Name  Dr Aastha Purohit 
Address  Third Floor. Room number 2, Department of Orthodontics and Dentofacial Orthopaedics, Inderprastha Dental College and Hospital, 46/1 Site 4 Industrial Area Sahibabad Ghaziabad Uttar Pradesh, 201010. Ghaziabad 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vineet Golchha  Inderprastha Dental College & Hospital   Third Floor Department of Orthodontics and dentofacial orthopaedics, 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010 Ghaziabad UTTAR PRADESH
Ghaziabad
UTTAR PRADESH 
09990156222

orthovineet@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Inderprastha Dental College & Hospital Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers without any systemic illness, good oral hygiene. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1)Control group not receiving Laser Irradiation and Vibratory stimulation 2)group receiving Laser Irradiation and Vibratory stimulation 3)group receiving Vibratory stimulation  Comparison in the levels of Orthodontic tooth movement, and Gingival Crevicular in between Control group not receiving Laser Irradiation and Vibratory stimulation, group receiving Laser Irradiation and Vibratory stimulation (1st quadrant of maxilla in experimental - split mouth) group receiving Vibratory stimulation (2nd quadrant of maxilla in experimental - split mouth) 
Intervention  Laser Irradiation, Vibratory stimulation  Lasers and vibrations are used normally in orthodontia to increase the rate of tooth movement, this falls under the rapid acceleratory phenomena. one group will recieve low level laser irradiation on one side and vibration on both the sides of the upper jaw. Laser Irradiation: A medium diode laser equipment (BIOLASE EPIC LASER) will be used for the study, emitting infra-red radiation at 940nm, at a continuous wave mode. All irradiations will be done by the same operator with an output power of 100mW, and exposure time of 3 second at each point. Canine of first quadrant of maxilla of experimental group will receive laser irradiation. Vibratory Stimuli: Mechanical tooth brush with a high frequency of 150 Hz will be used. Patient will be asked to brush with it twice a day for six minutes each time (12 minutes). Both the quadrants of maxilla will receive vibratory stimuli. 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Healthy Individuals with no systemic illness requiring maxillary first premolar extraction.
Good oral
hygiene and periodontal health.
No developmental anomaly.
No history of previous orthodontic treatment. 
 
ExclusionCriteria 
Details  History of trauma.
Patients with systemic illnesses
Taking medications that interfere with orthodontic tooth movement
Patients with parafunctional habits
Severely periodontally compromised.
Periapical inflammation of cysts/ tumors. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The efficacy of high frequency vibrations
combined with low level laser therapy is
expected to be higher than low level laser
therapy which is higher than control group which
is not receiving any laser or vibration therapy on
the levels of Interleukin-1 beta and Interleukin-8
in Gingival Crevicular Fluid. 
3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Group receiving high frequency vibrations
combined with low level laser therapy is
expected to increase orthodontic tooth
movement most followed by group receiving only
low level laser therapy followed by control group
which is not receiving any laser or vibration
therapy 
3 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)   28/08/2022 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

 Purpose & Background: Orthodontic treatment takes a long time therefore different methods like lasers and vibrations separately were used to increase orthodontic tooth movement thereby reducing treatment time. However, some studies showed a significant increase in tooth movement and some did not. Therefore, the purpose of this study is to compare the orthodontic tooth movement with the use of vibrations and lasers together with only lasers and without lasers or vibrations. If there is an increase in tooth movement the total treatment time will be reduced and therefore will be beneficial to both patient and the clinician.

 30 patients coming to the Department of Orthodontics and Dentofacial Orthopaedics, Inderprastha Dental College and Hospital  requiring maxillary first premolar extraction will be considered for the study.

v  After patient selection, the patient will be informed about the study and if he/she agrees with the protocol, the consent form will be signed by the patient.

v All patients will  receive repeated oral hygiene instructions.

v (T0) : After both maxillary first premolar extraction a sample of GCF  will be collected to estimate the levels of IL-1 Beta and IL-8 from the pressure site of the right maxillary canine. Enzyme Linked Immunoassay (ELISA) would be done for this evaluation.

v Patients would be divided into two groups  having 15 patients each.

v Levelling and aligning procedures will be done.

v (D1): Distance between the cusp tip of canine and mesio buccal cusp tip of 1st molar will be measured using calliper.

v This is followed by canine retraction, which will be done by NiTi closed coil spring positioned from the canine bracket to the first molar buccal tube.

v Same material and method will be applied for canine retraction for both the groups.

v GROUP 1: No additional stimuli will be given.

v GROUP 2 : Patients of this group will be given a mechanical tooth brush with a high frequency of 150 Hz and will be asked to brush with it twice a day for six minutes each time (12 minutes).

Ø Laser Irradiation: On the right side of the maxilla of the patients of group 2 laser irradiation will be carried out.

v A medium InGaAsP Semi-conductor diode laser equipment (BIOLASE EPIC LASER)  will be used for the study, emitting infra-red radiation at 940nm, at a continuous wave mode. All irradiations will be done by the same operator with an output power of 100mW, and exposure time of 3 second at each point.

The tip will be held perpendicular to and in contact with the gingival mucosa during the laser irradiation procedure. Protection glasses were worn by both the operator and the patients. Total of 10 irradiations will be carried out each time, five on the buccal side and five on the palatal side of the canine of the laser group:

v Two mesial,

v One medial,

v Two distal.

v Laser irradiation will be done  on 1st, 7th, 15th, 30th, 45th, 60th, 75th , 90th day of canine retraction.

v The procedure will be followed on all subsequent appointments.

v  (T1): GCF fluid samples will again be collected at the end of three months from both the groups, which will be analysed for the levels of IL-1 beta and IL-8. 

v (D2): The distance between the cusp tips of the canine and the mesio buccal cusp tip of the first molar will be measured with a caliper.

v The collected data will be compared and statistically analysed.

v ANOVA test will be carried out.

v A statistician will be consulted for expert opinion and modifications will be made if necessary. 

 
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