| 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
|
|
|
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
|
|
|
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. |