| CTRI Number |
CTRI/2024/11/077426 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect Of Low-level Laser Therapy On Reducing Orthodontic Pain during separator placement. |
|
Scientific Title of Study
|
Effect Of Low-level Laser Therapy On Reducing Orthodontic Pain – A Split-mouth 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 Adarsh Ninan Sam |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Department of Orthodontics & Dentofacial Orthopaedics, Manipal College of Dental Sciences, Manipal, Udupi, Karnataka - 576104
Manipal College of Dental Sciences,
Madhav Nagar, Manipal, Udupi District, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8606666155 |
| Fax |
|
| Email |
adarsh1.mcodsmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya S |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Department of Orthodontics & Dentofacial Orthopaedics, Manipal College of Dental Sciences, Manipal, Udupi, Karnataka, India - 576104
Manipal College of Dental Sciences,
Madhav Nagar, Manipal, Udupi District, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9632156731 |
| Fax |
|
| Email |
divya.s@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Adarsh Ninan Sam |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Department of Orthodontics & Dentofacial Orthopaedics, Manipal College of Dental Sciences, Manipal, Udupi, Karnataka - 576104
Manipal College of Dental Sciences,
Madhav Nagar, Manipal, Udupi District, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8606666155 |
| Fax |
|
| Email |
adarsh1.mcodsmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences, Manipal, Udupi District, Karnataka, India. - Pin- 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Adarsh Ninan Sam |
| Address |
Department of Orthodontics & Dentofacial Orthopaedics, Manipal College of Dental Sciences, Manipal, Udupi, Karnataka - 576104 |
| 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 Adarsh Ninan Sam |
Manipal College of Dental Sciences |
Room No. 7, Department of Orthodontics & Dentofacial Orthopedics, Manipal College of Dental Sciences, Madhav Nagar, Manipal, Udupi, Karnataka - 576104
Udupi
KARNATAKA |
8606666155
adarsh1.mcodsmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low-level laser therapy |
0.5-mm posterior elastomeric separators (Optima Separators, Desire Orthodontics, Karnataka) will be inserted at the mesial and distal side of each maxillary first molar. The elastic separator placement time will be kept uniform at 10am +/- 1hr for each patient. After separator placement, the patient will be sent to the Department of Advanced Courses, Manipal College of Dental Sciences, Manipal for the application of Low-Level Laser Application on the treatment side.
Patients will be made to wear the protective glasses before the start of treatment, so they will be blinded to the intervention. The side selection for treatment and placebo application will be done using draw method.
For the molar to be irradiated, a LLLT will be applied using an Biolase EpicX Diode Laser at 940nm Wavelength in continuous emission mode with 2-4Joules Energy for 20 seconds. (BIOLASE, INC., 4 Cromwell, CA 92618, USA)
An initial application of LLLT to be done on the 1st day immediately after the placement of Separator and the second application on the 3rd Day after separator placement.
Laser beam to be applied to one point on both the mesial and distal sides of the molar at the level of the cervical third of the root, perpendicular to the mucosa and in direct contact with it. The result will be recorded on Visual Analogue scale by the patient every 12hrs till the 4th day of Low Level Laser therapy application. The total procedure takes approximately 20min from the separator placement till the application of the laser therapy. |
| Comparator Agent |
Sham Laser |
Placebo treatment was implemented by applying the laser device to the other maxillary first molar with the same manner and exposure time compared to the intervention side. Difference will be turning on the device without emitting the laser beam to obtain the placebo effect. The duration for the procedure will be 20min similar to the intervention side. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
1. Good oral hygiene
2. No systemic or periodontal diseases
3. No intake of medications that interfere with pain perception for at least one week before the beginning of the treatment and also during the course of study
4. Intact maxillary first molars and the presence of healthy contact points of the maxillary first molars with adjacent teetH |
|
| ExclusionCriteria |
| Details |
1. The intake of NSAIDs or analgesics during the study.
2. Failing to complete the questionnaire
3. Patient who received previous orthodontic treatment. |
|
|
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 and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Low-Level Laser Therapy in reducing the pain on separator placement in Maxillary 1st Molars. |
The timepoints to measure the outcome will be every 12hrs till 4th day from the time of Low Level Laser Therapy Application. (0hrs, 12hrs, 24hrs,36hrs, 48hrs, 60hrs, 72hrs, 96hrs) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of 2 application of low-level laser with 2-4 Joule energy at 940nm wavelength on pain reduction following elastomeric separator placement. |
72 weeks |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
09/12/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The study will involve randomly selecting patients aged 18-24 who meet the inclusion criteria. Double blinding will be used, where both the statistician and patient will be unaware of the procedures. After obtaining informed consent, patient-specific inclusion criteria will be recorded, and the intervention side will be assigned using a draw method with allocation concealment. Patients will receive posterior elastomeric separators on their maxillary first molars, and LLLT will be applied on the treatment side using a Biolase EpicX Diode Laser. A placebo treatment will be given on the other molar with the same procedure, but no laser emission. Both the laser and placebo treatments will occur at the same time, with patients blinded to the treatment assignment. Pain levels will be assessed using a Visual Analogue Scale (VAS) at various time points after both treatments, with follow-up on days 1 and 3 after separator placement. The evaluation includes pain measurements at multiple intervals (12, 24, 36, 48, 60, 72, 84, 96 hours post-treatment). |