FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
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 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  
Status 
Not Applicable 
 
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.

 
Close