| CTRI Number |
CTRI/2024/06/069011 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
27/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Preventive |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Testing the Efficacy of a Single Dose of Ketorolac and Paracetamol in reducing the pain cause by metal braces treatment procedure in adolescents |
|
Scientific Title of Study
|
Evaluating the Efficacy of a Single Preemptive Dose of Ketorolac and Paracetamol for Managing Orthodontic Procedure Pain in Adolescents: A Randomized Controlled Trial |
| 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 Yatishkumar Joshi |
| Designation |
Vice Principal & Professor |
| Affiliation |
MIDSR Dental College Latur, Maharashtra |
| Address |
Department of orthodontics and Dentofacial Orthopedics, MIDSR Dental College Latur-413512, Maharashtra, India.
Latur MAHARASHTRA 413512 India |
| Phone |
9860636690 |
| Fax |
|
| Email |
orthoyatishjoshi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Disha Limbraj Khandade |
| Designation |
Postgrauate Student |
| Affiliation |
MIDSR Dental College Latur |
| Address |
Department No. 7, Department of orthodontics and dentofacial
orthopedics, MIDSR Dental College, Latur.
Latur MAHARASHTRA 413512 India |
| Phone |
9370315496 |
| Fax |
|
| Email |
dishakhandade@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Disha Limbraj Khandade |
| Designation |
Postgrauate Student |
| Affiliation |
MIDSR Dental College Latur, Maharashtra |
| Address |
Department No. 7, Department of orthodontics and dentofacial
orthopedics, MIDSR Dental College, Latur.
Latur MAHARASHTRA 413512 India |
| Phone |
9370315496 |
| Fax |
|
| Email |
dishakhandade@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra Institute of Dental Sciences and Research Dental College Latur-413512, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Disha khandde |
| Address |
Department of orthodontics and dentofacial
orthopedics, MIDSR Dental College, Latur-413512, Maharashtra, India. |
| 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 Disha Limbraj Khandae |
MIDSR dental College Latur |
Department of
Orthodontics and
Dentofacial Orthopedics,
MIDSR Dental College, Vishwanathpuram, Latur-413512 Latur MAHARASHTRA |
9370315496
dishakhandade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maeers Maharashtra Institute of Dental Sciences And Research (Dental College), Latur Institutional Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketorol |
Patient will receive Single Ketorol tablet orally (10 mg) 30 min before starting the procedure |
| Intervention |
Paracetamol |
Patient will receive Single Paracetamol tablet orally (500 mg) 30 min before starting the procedure |
| Comparator Agent |
Placebo or Lactose Tablet |
Patient will receive Single Lactose tablet (placebo) orally 30 min before starting the procedure |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Age: above 14 years
weight: above 45 kg
Currently undergoing orthodontic treatment with planned procedures requiring moderate pain management (eg. archwire changes)
Understanding and willingness to provide informed consent (or parental consent for minors). |
|
| ExclusionCriteria |
| Details |
History of allergy or hypersensitivity to paracetamol or ketorolac.
Currently using any antibiotics or analgesics.
Patients with systemic disease, syndromic condition or medically compromised patients. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the intensity of pain experienced by the patient during the orthodontic treatment procedure with and without NSAID (Paracetamol and Ketorol) intervention. |
4 time points to check intensity of pain: Immediately after the procedure, After 6hr, After 24hr, After 48hr. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Which NSAIDs are more effective in controlling the pain caused during the orthodontic treatment procedure Paracetamol or Ketorol. |
4 time points to check intensity o pain: immediately after the procedure, 6 hours, 24 hours, 48 hours |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/06/2024 |
| Date of Study Completion (India) |
25/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Orthodontic Treatment, while aiming for aesthetically pleasing outcomes, frequently induces orofacial pain and discomfort in patients. There are various methods for the management of pain caused by orthodontic procedures such as nonsteroidal anti-inflammatory drugs (NSAIDs). This study aims to evaluate the efficacy of a single preemptive dose of ketorolac and paracetamol in managing pain associated with orthodontic procedures in adolescents. This crossover clinical trial study will be double-blinded and will be conducted on randomly selected 150 adolescents who are undergoing fixed orthodontic treatment. Each patient will randomly receive three different drugs (Ketorol 10 mg, Paracetamol 500 mg, and placebo or Lactose) at separate appointments, with a one-month interval between each administration. The masking of the drugs will be done by packing them in separate, identical-looking packets labeled with the patient’s name. Patients and investigators will be unaware of the content of the tablets (double blinding) received until the end of the study. This helps to reduce bias in the results. During the 1st appointment, the patient will be trained on how to record his pain perception on the visual analog scale after the orthodontic procedure. After that at each stage, patients will be prescribed a single preemptive dose, 1 hour before the archwire activation. Each patient will thereafter be asked to note the degree of pain perceived at specific intervals of time (immediately after the procedure, 6 hours, 24 hours, 48 hours) on the 100-mm visual analog scale (VAS). Intraprocedural pain will be recorded immediately after the completion of the procedure. Postprocedural pain will be assessed at 6 hours, 24 hours, and 48 hours after the orthodontic treatment. In each level, questionnaires will be collected and the effects of three drugs will be compared. |