FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/01/011352 [Registered on: 16/01/2018] Trial Registered Retrospectively
Last Modified On: 11/01/2018
Post Graduate Thesis  Yes 
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 the effect of 0.074% Diclofenac sodium mouthwash and 50 mg diclofenac sodium tablet in reduction of pain and swelling after gum surgery for pyorrhea. 
Scientific Title of Study   A randomized prospective split-mouth clinical study to compare the post-operative analgesic and anti-inflammatory effect of diclofenac sodium (0.074% mouthwash or 50mg tablets) after periodontal flap surgery. 
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 Amit Agrawal 
Designation  Post graduate Guide 
Affiliation  MGVs KBH Dental College and Hospital 
Address  MGVs KBH Dental College and Hospital, Panchavati, Nashik
Panchavati, Nashik
Nashik
MAHARASHTRA
422003
India 
Phone  9822107562  
Fax    
Email  agrodent@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shreeprasad V Wagle 
Designation  Post graduate student 
Affiliation  MGVs KBH Dental College and Hospital 
Address  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 [] 
 
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  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 conventional periodontal flap surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Diclofenac Sodium 0.074% mouthwash  After periodontal flap surgery either 0.074% diclofenac sodium mouthwash will be given or 50 mg tablet of same drug will be given. And analgesic and anti-inflammatory effect will be checked. 
Comparator Agent  Diclofenac Sodium 50 mg tablet   After periodontal flap surgery either 0.074% diclofenac sodium mouthwash will be given or 50 mg tablet of same drug will be given. And analgesic and anti-inflammatory effect will be checked. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients having periodontal pocket depth ranging from 5mm to 8mm.
2. Patients indicated for periodontal surgery bilaterally in same arch.
3. Systemically healthy patients.
 
 
ExclusionCriteria 
Details  1. Patients having endo-perio lesions.
2. Patients requiring resective osseous surgery or regenerative osseous surgery.
3. Patients with the history of intolerance or hypersensitivity to diclofenac.
4. Any systemic diseases or condition that affects the oral tissues,
5. Pregnant or lactating women.
6. Acute gingival or periodontal disease.
7. Patients on oral/systemic NSAIDs therapy for the last three months.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Diclofenac sodium local application (0.074% mouthwash) will have equal analgesic effect as compared to its systemic administration (tablet), but it would be better in terms of its anti-inflammatory effect and patient’s acceptability when used after periodontal flap surgery.  Analgesic effect will checked on 1st 2nd 3rd and 4th day after surgery. Inflammation will be assessed after 7 days 1 month and 3 months after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   28/11/2017 
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)  Open to Recruitment 
Publication Details   Not published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

All the patients will be screened for periodontal findings. Sites meeting the inclusion criteria will be considered for the present study. This study is designed as randomized prospective split-mouth clinical trial.

In test group patients will be given 0.074% diclofenac sodium mouthwash to be used at home for four days. Patients in this group need to use the mouthwash for 1 min, twice daily for 4 days, starting one immediately after surgery. Test group patients will also prescribed diclofenac sodium 50mg tablet to be used if pain is not controlled by diclofenac mouthwash alone. Number of tablets used by the patient (if any) will also be recorded on their proforma sheet. In control group, patient will be prescribed diclofenac sodium 50mg tablet twice daily for 4 days starting immediately after surgery.

Randomization with regard to the choice of quadrant and choice of drug formulation (mouthwash or tablet) will be done by coin toss method. At least 15 days gap will be maintained for second surgery in contralateral side when mode of therapy will be switched.

Clinical parameters will be checked at baseline, 7 days after surgery 1 month and 3 months after surgery. Pain perception of patient will be scored using Numerical Rating Scale. Data will be collected telephonically in the evening daily for 4 days. Along with that patient will be given ‘Wong Baker scale’ score sheet too and will be asked to fill it in the evening daily for 4 days. No perio dressing will be placed after surgery in either group. At 7 days follow-up patient will be asked about the acceptability of the mouthwash. At last follow-up of second surgery, patient will be asked about their personal preference between mouthwash and tablet for pain reduction.

We hypothesize that diclofenac sodium local application (0.074% mouthwash) will have equal analgesic effect as compared to its systemic administration (tablet), but it would be better in terms of its anti-inflammatory effect and patient’s acceptability when used after periodontal flap surgery.

 
Close