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CTRI Number  CTRI/2024/07/070031 [Registered on: 05/07/2024] Trial Registered Prospectively
Last Modified On: 30/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Other 
Public Title of Study   Comparing efficacy of diclofenac tablets and diclofenac patch after surgical removal of lower last tooth on opposite sides.  
Scientific Title of Study   Comparison of Pain relief with transdermal diclofenac patch and oral diclofenac sodium folloWing surgical removal of impacted mandibular third molars- a split mouth study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  R Kavyaraj 
Designation  Junior Resident 
Affiliation  Government Dental College, Kottayam 
Address  DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, RESIDENT PG HOSTEL GOVERNMENT DENTAL COLLEGE KOTTAYAM PERUMBAIKAD GANDHINAGAR, KERALA KOTTAYAM

Pathanamthitta
KERALA
686008
India 
Phone  9496139592  
Fax    
Email  rkavyaraj1996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  R Kavyaraj 
Designation  Junior Resident 
Affiliation  Government Dental College, Kottayam 
Address  DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, RESIDENT PG HOSTEL GOVERNMENT DENTAL COLLEGE KOTTAYAM PERUMBAIKAD GANDHINAGAR, KERALA KOTTAYAM
RESIDENT PG HOSTEL
Pathanamthitta
KERALA
686008
India 
Phone  9496139592  
Fax    
Email  rkavyaraj1996@gmail.com  
 
Details of Contact Person
Public Query  
Name  R Kavyaraj 
Designation  Junior Resident 
Affiliation  Government Dental College, Kottayam 
Address  DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, RESIDENT PG HOSTEL GOVERNMENT DENTAL COLLEGE KOTTAYAM PERUMBAIKAD GANDHINAGAR, KERALA KOTTAYAM

Pathanamthitta
KERALA
686008
India 
Phone  9496139592  
Fax    
Email  rkavyaraj1996@gmail.com  
 
Source of Monetary or Material Support  
R KAVYARAJ DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,GOVERNMENT DENTAL COLLEGE B BLOCK ROOM NO 103 GANDHINAGAR KOTTAYAM 
 
Primary Sponsor  
Name  R Kavyaraj 
Address  DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, GOVERNMENT DENTAL COLLEGE KOTTAYAM PERUMBAIKAD GANDHINAGAR, KERALA KOTTAYAM 
Type of Sponsor  Other [Government Dental College] 
 
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 R Kavyaraj  Department of Oral and Maxillofacial Surgery,Government dental College, Kottayam  Government Dental college, Kottayam, Kerala-686008
Kottayam
KERALA 		 9496139592

rkavyaraj1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT DENTAL COLLEGE KOTTAYAM KERALA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K011||Impacted teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Diclofenac transdermal patch  Intervention group: diclofenac transdermal patch 100mg applied topically over upper arm once daily for 3 consecutive postoperative days following surgical removal of impacted mandibular 3rd molar on one side. 
Comparator Agent  Oral diclofenac sodium  comparater: tab diclofenac sodium 100mg(Voveran 50) orally, once daily in two divided doses for 3 postoperative consecutive days following surgical removal of impacted mandibular 3rd molar in contralateral side. 
Comparator Agent  Tab paracetamol 500mg  Rescue medication: Tab paracetamol 500mg orally will be given along with Tab diclofenac sodium and Transdermal diclofenac patch as rescue medication. It has to be used if only needed(sustained pain) for the prescribed time period(3 consecutive postoperative days).  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients presenting to Government dental College, Kottayam with bilateral impacted lower third molars. 
 
ExclusionCriteria 
Details  Patients on anticoagulant therapy.
Patients with uncontrolled systemic diseases.
Patients allergic to diclofenac or any NSAIDs. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain relief  2hours, 6hours and 12hours interval on 3 consecutive post operative days. 
 
Secondary Outcome  
Outcome  TimePoints 
(Same as primary outcome).To compare pain relief following surgical removal of mandibular third molar with oral & transdermal diclofenac And also to compare the same with or without rescue medication using pain relief scale & numeric rating scale.  (Same as for primary outcome)at an interval of 2hr, 6hr & 12hr for first 3 consecutive postoperative days. 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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 2/ Phase 3 
Date of First Enrollment (India)   08/07/2024 
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 Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rkavyaraj1996@gmail.com].

  6. For how long will this data be available start date provided 01-11-2025 and end date provided 30-11-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   In patients with bilaterally impacted mandibular third molar, following removal of the impacted third molar on one side, patients were given oral diclofenac 100mg daily in two divided doses for the 3 postoperative consecutive days. For the other side, a 100mg transdermal diclofenac patch was used. Drugs were administered one hour before surgery, with sides and drugs randomly chosen. Patients received both forms of intervention and could use oral paracetamol 500mg as rescue medication if needed in sustained pain. Pain was recorded using PRS and NRS scales at 2hr, 6hr and 12hr intervals for 72 hours postoperatively. The purpose of this trial is to compare the efficacy of transdermal diclofenac patch with oral diclofenac sodium in pain relief after surgical removal of impacted mandibular third molar and to compare the same with or without rescue medication. 
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