FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/01/011365 [Registered on: 16/01/2018] Trial Registered Retrospectively
Last Modified On: 15/01/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A clinical study to compare pain reduction effect of diclofenac sodium mouthwash with diclofenac sodium tablet after gum surgery; a pilot study. 
Scientific Title of Study   A prospective cross-over clinical study to compare the effect of locally (mouthwash) or systemically (tablets) delivered diclofenac sodium after periodontal surgery, a pilot study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shreeprasad V Wagle 
Designation  Post graduate student 
Affiliation  MGVs KBH Dental College and Hospital 
Address  Room number 202, department of periodontology and implantology, MGVs KBH Dental College and Hospital Panchavati Nashik
Panchavati, Nashik
Nashik
MAHARASHTRA
422003
India 
Phone  8308068269  
Fax    
Email  svw1593@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shreeprasad V Wagle 
Designation  Post graduate student 
Affiliation  MGVs KBH Dental College and Hospital 
Address  Room number 202, department of periodontology and implantology, MGVs KBH Dental College and Hospital Panchavati Nashik
Panchavati, Nashik
Nashik
MAHARASHTRA
422003
India 
Phone  8308068269  
Fax    
Email  svw1593@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shreeprasad V Wagle 
Designation  Post graduate student 
Affiliation  MGVs KBH Dental College and Hospital 
Address  Room number 202, department of periodontology and implantology, MGVs KBH Dental College and Hospital Panchavati Nashik
Panchavati, Nashik
Nashik
MAHARASHTRA
422003
India 
Phone  8308068269  
Fax    
Email  svw1593@gmail.com  
 
Source of Monetary or Material Support  
Department of periodontology and implantology MGVs KBH dental college and Hospital Nashik  
 
Primary Sponsor  
Name  none 
Address  none 
Type of Sponsor  Other [none] 
 
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 Shreeprasad V Wagle  MGVs KBH Dental college and Hospital  Room number 202, department of Periodontology and Implantology, MGVs KBH Dental college and hospital, Panchavati, Nashik
Nashik
MAHARASHTRA 		 8308068269

svw1593@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Mahatma Gandhi Vidyamandir KBH Dental College and Hospital Nashik  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients indicated for periodontal surgeries.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Diclofenac Sodium 0.074% mouthwash   After periodontal surgery either 0.074% diclofenac sodium mouthwash will be given or 50 mg tablet of same drug will be given. And analgesic effect will be checked by NRS index.  
Comparator Agent  Diclofenac Sodium 50 mg tablet   After periodontal surgery either 0.074% diclofenac sodium mouthwash will be given or 50 mg tablet of same drug will be given. And analgesic effect will be checked by NRS index.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Systemically healthy patients.
2. Patients indicated for periodontal surgeries.
 
 
ExclusionCriteria 
Details  1. Patients with the history of intolerance or hypersensitivity to diclofenac.
2. Any systemic diseases or condition that affects the oral tissues,
3. Pregnant or lactating women.
4. Patients on oral/systemic NSAIDs therapy for the last three months.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Topical formulation of diclofenac sodium will be sufficiently effective for pain relief after periodontal surgical procedures when compared to systemic formulation of diclofenac sodium.  Analgesic effect will checked on 1st 2nd 3rd and 4th day after surgery by NRS index. 
 
Secondary Outcome  
Outcome  TimePoints 
none  none 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/08/2017 
Date of Study Completion (India) 24/11/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Introduction: Local drug delivery is well known for its advantages over systemic drug therapy. Among NSAID’s, Diclofenac is most commonly used analgesic and anti-inflammatory agent. Its mouthwash preparation has gained attention but there has not been any cross-over study reported in literature. 

Material and methods: Ten patients, indicated for periodontal surgeries, randomly received diclofenac mouthwash for 1 min, twice daily for 4 days or diclofenac tablet twice daily for 4 days. After atleast 15 days second surgery was performed and mode of therapy was switched. Patient was asked to score NRS index either personally or telephonically for those 4 days. Collected data was tabulated and analysed. 

Hypothesis: After periodontal surgery diclofenac sodium local application (0.074% mouthwash) will have equal analgesic effect as compared to its systemic administration (tablet). 
 
Close