FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/077989 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 09/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to compare the efficacy of diclofenac oral rinse versus diclofenac tablet versus chewing gum in management of orthodontic pain 
Scientific Title of Study   Comparative assessment of analgesic (Topical and systemic) and chewing gum in the management of orthodontic pain: 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 sarfaraz akhtar 
Designation  MDS 1st year 
Affiliation  darshan dental college and hospital 
Address  Department of orthodontics and dentofacial orthopedics, Darshan dental college and hospital, Ranakpur road, Loyara, Udaipur

Udaipur
RAJASTHAN
313011
India 
Phone  08003752127  
Fax    
Email  sarfaraz.akh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Trivedi rutvik 
Designation  Reader 
Affiliation  darshan dental college and hospital 
Address  Darshan dental college and hospital, Ranakpur road, Loyara, Udaipur, rajasthan. 313011
House No 10, 60 feet Venice Apartment Road, Meeranagar B block, Bhuwana, Udaipur, rajasthan. 313001.
Udaipur
RAJASTHAN
313011
India 
Phone  08003752127  
Fax    
Email  dr.rutviktrivedi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr sarfaraz akhtar 
Designation  MDS 1st year 
Affiliation  darshan dental college and hospital 
Address  Department of orthodontics and dentofacial orthopedics, Darshan dental college and hospital, Ranakpur road, Loyara, Udaipur

Udaipur
RAJASTHAN
313011
India 
Phone  08003752127  
Fax    
Email  sarfaraz.akh@gmail.com  
 
Source of Monetary or Material Support  
Darshan dental college and hospital, loyara, udaipur, rajasthan. 313011 
 
Primary Sponsor  
Name  Dr sarfaraz akhtar 
Address  Room no.210, Pratap boys hostel, darshan dental college and hospital, Ranakpur road, Loyara, Udaipur, rajasthan. 313011 
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 Sarfaraz akhtar  Darshan dental college and hospital  Department of orthodontics and dentofacial orthopedics (no.8), second floor, Darshan dental college and hospital, loyara, udaipur,rajasthan. 313011
Udaipur
RAJASTHAN 
08003752127

sarfaraz.akh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, Sai Tirupati University, Udaipur (Rajasthan), India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M263||Anomalies of tooth position of fully erupted tooth or teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chewing Gum  xylitol chewing gum (sugar free and non sticky) Patients have to take the chewing gum 4 times a day. 
Comparator Agent  Control group  Patient will not be provided with any pain treatment modalities after archwire placement. Patients will put the values of pain on visual analog scale.  
Intervention  Diclofenac mouth wash  Diclofenac oral rinse 0.074% 10ml per use, thrice a day For 3 days. Topical route of administration  
Comparator Agent  Tab. Diclofenac  Tab. Diclofenac 100mg once a day for 3 days will be given to patients. Oral route of administration  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  32.00 Year(s)
Gender  Both 
Details  1. Patients with mild to moderate Crowding
2. Patients within age group 18-32 years
3. No previous Orthodontic treatment history 
 
ExclusionCriteria 
Details  1. Patients with active periodontal diseases
2. Allergic to diclofenac
3. Autoimmune disease
4. Pregnant and lactating Women
5. Cardiovascular disease
6. History of gastritis or peptic ulcer 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
topical analgesic form is similarly potent as compared to its systemic analgesic form in management of orthodontic pain.  baseline (2 hours after initial wire placement), upto 4 days  
 
Secondary Outcome  
Outcome  TimePoints 
Analgesic oral rinse and xylitol chewing gum can be an efficient modality in orthodontic pain management as well as more convenient to the patints.  baseline (2 hours after initial wire placement), upto 4 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3/ Phase 4 
Date of First Enrollment (India)   20/12/2024 
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)   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  

Pain is a subjective response showing large individual variations, when arising from orthodontic force application is a major concern for patients, parents and clinicians. Diclofenac is a potent anti-inflammatory drug that is well suited for local use in the oral cavity. The drug results in decreased production of Prostaglandins hence, reduce inflammation or swelling and pain.

 â€œIt is hypothesized that diclofenac oral rinse would be a better alternative to its systemic administration, in terms of patient acceptance"

There are several other non-pharmacological methods for orthodontic pain relief and masticatory stimulation of the periodontal ligament such as the chewing of gum or use of bite wafers has been reported to alleviate pain induced by the application of orthodontic force. Chewing rubbery materials allows blood flow in compressed areas of the periodontal ligament and prevents the formation of pain-inducing inflammatory metabolites, thereby attenuating pain perception. Hence, this study is planned to assess and compare the efficacy of diclofenac (local and systemic form-oral route) and chewing gum (non sticky and sugar free) with control group in the management of orthodontic pain

Procedure of conduction of research: - The participants will be evaluated on the basis of mild to moderate crowding followed by the inclusion criteria. Randomized allotment will be done in the four groups respectively. A 0.014” Cu NiTi wire will be placed in patient’s mouth after bonding is done with conventional metal brackets. Pain relief remedies will be provided as per group allotments with a questionnaire which will be collected in the next appointment and instruction will be given. The filling of questionnaire on proper time will be assessed through telephonic reminders.

Predesigned pain questionnaire including visual analog scale will be given to the patients and will be collected in the next appointment.



 
Close