CTRI Number |
CTRI/2018/02/011753 [Registered on: 07/02/2018] Trial Registered Retrospectively |
Last Modified On: |
06/02/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Dentistry Other (Specify) [Non randomized cross over trial] |
Study Design |
Other |
Public Title of Study
|
Comparison of the pain killer patch and pain killer tablet for post teeth extraction pain in bilateral teeth extractions |
Scientific Title of Study
|
Comparative evaluation of transdermal diclofenac and oral diclofenac in management of post operative pain in bilateral extractions an in vivo 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 C Swaminathan |
Designation |
Post graduate student, Department of Oral and Maxillo Facial Surgery. |
Affiliation |
Sree Mookambika Institute of Dental Science |
Address |
15-178/10, NIS Complex First floor,
Opp to Sree Mookambika institute of medical Science, Padanilam, Kulasekharam.
Kanniyakumari TAMIL NADU 629161 India |
Phone |
9444663867 |
Fax |
|
Email |
dr.swaminathan1990@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr C Swaminathan |
Designation |
Post graduate student, Department of Oral and Maxillo Facial Surgery. |
Affiliation |
Sree Mookambika Institute of Dental Science |
Address |
15-178/10, NIS Complex First floor,
Opp to Sree Mookambika institute of medical Science, Padanilam, Kulasekharam.
Kanniyakumari TAMIL NADU 629161 India |
Phone |
9444663867 |
Fax |
|
Email |
dr.swaminathan1990@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Dhinekshkumar |
Designation |
Professor and Post Graduate Guide Department of Oral and Maxillofacial Surgery |
Affiliation |
Sree Mookambika institute of Dental science |
Address |
Dr Dhinekshkumar,
Professor,Room no.2,
Department of Oral and Maxillo Facial Surgery,
Sree Mookabika Institute of Dental Science, Padanilam, Kulasekharam.
Kanniyakumari TAMIL NADU 629161 India |
Phone |
|
Fax |
|
Email |
dhineksh@gmail.com |
|
Source of Monetary or Material Support
|
Sree Mookambika institute of Dental Science, VPM hospital complex, padanilam, kulasekharam, Kanyakumari dist, Tamil nadu. pin 629161 |
|
Primary Sponsor
|
Name |
Dr C Swaminathan |
Address |
15-178/10, NIS Complex First floor, Opp to Sree Mookamika institute of medical Science, Padanilam, Kulasekharam, Kanyakumari district, Tamil Nadu. pin - 629161 |
Type of Sponsor |
Other [self financing] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr C Swaminathan |
Sree Mookambika Institute of Dental Science |
room no.2 , post graduate division, Department of Oral and maxillofacial surgery,
Sree Mookambika Institute of dental Science, Padanilam, kulasekharam - 629161. Kanniyakumari TAMIL NADU |
9444663867
dr.swaminathan1990@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Human ethics Committee, Sree Mookambika Institute of Medical Science |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
post extraction pain , |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Diclofenac Diethylamine 100mg
transdermal patch |
Proprietary name - DicloPLAST 100,Marketed by - Zuventus healthcare ltd, Manufacturer - sparsha pharma international Ltd , Formulation - transdermal patch, Dosage - 100mg, Frequency and duration - once a day for three days, Site of application - right upper arm 2 hours before extraction of teeth in one side of the jaw, Emergency pain relief tablet - paracetamol 500mg |
Comparator Agent |
Diclofenac Sodium 50mg tablet |
Proprietary name - Fenac 50, Manufacturer - Ortin Laboratories Ltd, Formulation - tablet, Dosage - 50mg, frequency and duration - thrice a day for three days First dose - one hour before extraction of same teeth in opposite side of the jaw, Emergency pain relief tablet - paracetamol 500mg
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
55.00 Year(s) |
Gender |
Both |
Details |
Patient in the age group of 18-55 years will be selected irrespective of sex, caste, religion and socio-economic status.
Bilaterally extraction of same teeth in adjacent quadrants of the jaw.
Patients who agreed to follow the study protocol. |
|
ExclusionCriteria |
Details |
Uncontrolled systemic diseases.
Patient with anti-coagulant therapy.
Patient allergic to diclofenac or any NSAIDS
Patient under medication of NSAIDS or corticosteroids for any other illness.
Patient with history of peptic ulcer.
Tender teeth and third molars and periodontally compromised teeth.
Uncooperative patients not willing to commit to an appropriate post procedure follow-up. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
post operative pain score evaluation in
Visual analog scale (0-10)
Verbal rating scale (0-3)
Pain relief scale (0-3)
Pain intensity scale (0-3)
|
post operative pain after 2hour, 6hour and 12hour for three consecutive days |
|
Secondary Outcome
|
Outcome |
TimePoints |
when patient start consuming emergency pain tablets paracetamol500mg, number of tablet paracetamol 500mg consumed is calculated. |
Number of paracetamol 500mg tablet consumed in 24 hours is noted for three consecutive days. |
|
Target Sample Size
|
Total Sample Size="17" Sample Size from India="17"
Final Enrollment numbers achieved (Total)= "17"
Final Enrollment numbers achieved (India)="17" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/08/2016 |
Date of Study Completion (India) |
30/11/2016 |
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
|
Transdermal Drug delivery System offers various advantages like delivering drug painlessly and directly into the systemic circulation at a constant rate, minizing the Gastro intestinal side effects, possibility to terminate the delivery of drug abruptly. This study aims at comparing the efficacy of transdermal diclofenac diethylamine 100mg (dicloPLAST 100mg) with Oral Diclofenac soduium 50mg (Fenac 50) in post operative pain management in bilateral extractions. After proper case recording and selecting the patients based on inclusion and exclusion criterea, the procedure is thoroughly explained to the patient about the use of transdermal diclofenac patch as an alternative for oral diclofenac tablets. Patient is asked to take the preoperative diclofenac sodium 50mg tab one hour before the procedure. In Under aseptic precautions, armamentaria are prepared for extraction. Of the two teeth to be extracted in two quadrants, extraction of one tooth is performed under local anesthesia 2% with adrenaline 1:80000 (Lignox 2%) with tablet diclofenac 50mg one hour before procedure. Tablet diclofenac sodium 50mg (FENAC 50 - Ortin laboratories) tds for three days, Tablet Ranitidine 150mg (Rantac 150 - JB chemicals and Pharmacueticals Pvt Ltd) bid for three days and Capsule amoxicillin 500 mg (Mox 500 – Ranbaxy laboratories) tds for five days if needed are prescribed. Tablet Paracetamol 500mg (Dolo 500 - Micro labs Pvt Ltd) ten in number given to the patients as a rescue medication which can be taken in case of increase in pain. Patients are assigned to score the post operative pain three times in a three consecutive days in VAS – Visual analog scale, VRS – Verbal response scale, PIS- Pain intensity scale , PRS – pain relief scale after 2 hours, 6 hours and 12 hours and to stop the scoring there after if they required the tab paracetamol 500 for pain relief and from there number of paracetamol tablet is calculated. Patient is recalled for the next extraction one week for the next extraction. Patient is instructed to apply the diclofenac diethyleamine 100mg patch (dicloPLAST 100mg) over right upper arm two hour before procedure and the extraction of tooth in opposite side of the jaw is carried out under under local anesthesia 2% with adrenaline 1:80000 (Lignox 2%). Capsule Amoxicillin 500 mg (Mox 500) tds for five days is prescribed to the patient if needed. Patient is asked to change the patch and exactly 24 hours once exactly from the time of application for three days. Tablet Paracetamol 500mg (DOLO 500) ten in number are given to the patients as a rescue medication which can be taken in case of increase in pain. Patients are assigned to score the post operative pain three times in a three consecutive days as previously done and to and to stop the scoring there after if they required the tab paracetamol 500 for pain relief and from there number of paracetamol tablet is calculated.The null hypothesis is there is no difference in efficacy of Trandermal Diclofenac diethylemaine 100mg patch and Oral Diclofenac sodium 50mg in post operative pain management in bilateral extractions. |