| CTRI Number |
CTRI/2025/08/093730 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Light Therapy and Ibuprofen for Reducing Pain During Early Braces Treatment |
|
Scientific Title of Study
|
Comparison of efficacy of photobiomodulation therapy with ibuprofen in reducing pain perception associated with placement of elastomeric separator during initial orthodontic treatment |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayasmita Nag |
| Designation |
Post Graduate Trainee |
| Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Guru Nanak Institute of Dental sciences and research, 157/F,Nilgunj Road Sahid Colony panihati
nil
North Twentyfour Parganas
WEST BENGAL
700114
India |
| Phone |
9735008606 |
| Fax |
|
| Email |
ayasmitanag.bdc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RUPAM KUMARI |
| Designation |
PROFESSOR |
| Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Department of Orthodontics and dentofacial orthopedics, GURUNANAK INSTITUTE OF DENTAL SCIENCES AND RESEARCH, 157/F NILGUNJ ROAD SAHID COLONY PANIHATI
nil
North Twentyfour Parganas
WEST BENGAL
700114
India |
| Phone |
9875339134 |
| Fax |
|
| Email |
drkrupam2018@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ayasmita Nag |
| Designation |
Post Graduate Trainee |
| Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS, GURUNANAK INSTITUTE OF DENTAL SCIENCES AND RESEARCH . 157/F NILGUNJ ROAD SAHID COLONY PANIHATI
North Twentyfour Parganas
WEST BENGAL
700114
India |
| Phone |
9735008606 |
| Fax |
|
| Email |
ayasmitanag.bdc@gmail.com |
|
|
Source of Monetary or Material Support
|
| GURU NANAK INSTITUTE OF DENTAL SCIENCES AND RESEARCH, 157/F NILGUNJ ROAD SAHID COLONY PANIHATI KOLKATA WESTBENGAL ,PIN 700114 |
|
|
Primary Sponsor
|
| Name |
Dr. Ayasmita Nag |
| Address |
78, Dharmatala lane, Shibpur , Howrah. Pin : 711102 |
| 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 |
| Ayasmita Nag |
Guru Nanak Institute of Dental Sciences and Research |
Department of Orthodontics and Dentofacial Orthopedics,Guru Nanak Institute of Dental Sciences and Research,157/F Nilgunj Road, Sahid Colony, Panihati, Kolkata, Khardaha, West Bengal 700114
Kolkata
WEST BENGAL |
9735008606
ayasmitanag.bdc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Guru Nanak Institute of Dental Sciences and Research 157/F, Nilgunj Road Panihati, City Kolkata, District North 24 parganas west bengal 700114 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ibuprofen |
10mg per kg dose |
| Intervention |
Low level laser therapy |
Diode laser device of 650nm wavelength,500 mW energy for 10 seconds, continuous wave, contact mode |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring orthodontic banding with sound first permanent molars having proper proximal contact and permanent second molars should be completely erupted. |
|
| ExclusionCriteria |
| Details |
Patients with acute or gastritis, gastroenteritis , gastric ulcers, or suffering from any local or systemic condition that could affect pain perception and presence of posterior crossbite or open bite |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain reduction by photobiomodulation as compared to ibuprofen |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
10/09/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
Modification(s)
|
Orthodontic treatment-induced pain poses challenges, affecting patient compliance. Orthodontic forces trigger pain due to tooth movement and bone remodelling around roots, often managed with Non steroidal antiinflammatory drugs(NSAIDS). However, NSAIDs hinder tooth movement and entail systemic side effects like gastrointestinal problem, hepatotoxicity, hypertension, nephrotoxicity, increased risk of heart disease. Photobiomodulation therapy (PBMT), a non-pharmaceutical alternative, shows promise in reducing pain without systemic effects. Previous studies support PBMT’s effectiveness, making it a potential solution for discomfort after separator placement during orthodontic treatment, offering advantages over traditional NSAIDs. This study assesses photobiomodulation therapy’s efficacy for pain relief after separator placement, comparing its effectiveness to Ibuprofen in initial orthodontic treatment stages. This research has a split-mouth design. Elastomeric separators are applied to first molars in one quadrant, followed by immediate photobiomodulation therapy using a diode laser. Pain perception is recorded at various intervals using the Visual Analogue Scale (VAS). After seven days, the same process is repeated in the contralateral quadrant, but with a placebo therapy and prescribed Ibuprofen. Postoperative pain is assessed using VAS, and the data collected will be compared and analyzed to test hypotheses. The study aims to evaluate the effectiveness of photobiomodulation therapy in managing orthodontic pain compared to a placebo and pain relief medication. It is expected that both the therapies, i.e. photobiomodulation and Ibuprofen will reduce pain and the reduction of pain perception in both of the treatment modalities will vary. |