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CTRI Number  CTRI/2022/11/047485 [Registered on: 21/11/2022] Trial Registered Prospectively
Last Modified On: 21/11/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of transdermal vs oral ketoprofen in minor periodontal surgical procedure  
Scientific Title of Study   Comparative evaluation of the efficacy of transdermal ketoprofen patch and oral ketoprofen in management of post operative pain after minor periodontal surgery- A randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinita Krishna 
Designation  Post graduate student 
Affiliation  KLE VK Institute of dental sciences 
Address  Department of periodontics, KLE VK Institute of dental sciences J.N.M.C Campus, Nehru nagar, Belagavi
Department of periodontics, KLE VK Institute of dental sciences J.N.M.C Campus, Nehru nagar, Belagavi
Belgaum
KARNATAKA
590010
India 
Phone  08860533630  
Fax    
Email  k.vinita1995@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhishek N Zingade 
Designation  Reader 
Affiliation  KLE VK Institute of dental sciences 
Address  Department of periodontics, KLE VK Institute of dental sciences, JNMC Campus, Nehru nagar, Belagavi
Department of Periodontics, KLE VK Institute of dental sciences, JNMC Campus, Nehru nagar, Belagavi
Belgaum
KARNATAKA
590010
India 
Phone  08860533630  
Fax    
Email  abhi.zing@kledental-bgm.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Vinita Krishna 
Designation  Post gradauate student 
Affiliation  KLE VK INSTITUTE OF DENTAL SCIENCES 
Address  Department of periodontics, KLE VK Institute of dental sciences, JNMC Campus, Nehru nagar, Belagavi
Department of periodontics, KLE VK Institute of dental sciences, JNMC Campus, Nehru nagar, Belagavi
Belgaum
KARNATAKA
590010
India 
Phone  08860533630  
Fax    
Email  k.vinita1995@gmail.com  
 
Source of Monetary or Material Support  
self  
 
Primary Sponsor  
Name  Dr Vinita Krishna 
Address  Department of Periodontics KLE VK Institute of dental sciences JNMC Campus Nehru nagar Belagavi 590010 
Type of Sponsor  Other [Self funded] 
 
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 Vinita krishna  KLE VK Institute of dental sciences  Department of periodontics, KLE VK Institute of dental sciences, J.N.M.C Campus Nehru nagar Belagavi-590010
Belgaum
KARNATAKA 
08860533630

k.vinita1995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional research and ethics committee KLE VKIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Systemic healthy patients with indicated for minor periodontal surgical procedures 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Oral ketoprofen  Comparator- Oral Ketoprofen - 25 mg every 24 hours for 3 days after post-operative minor periodontal surgery 
Intervention  Transdermal ketoprofen patch  Intervention- Patch Ketoprofen -30mg every 24 hours for 3 days after post-operative minor periodontal surgery  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients between age group of 30 to 50 years indicated for minor periodontal surgery.
Patients requiring minor periodontal surgery such as frenectomy/frenotomy, operculectomy, gingivectomy, gingival depigmentation and surgical crown lengthening.
Patients willing to give informed consent.
 
 
ExclusionCriteria 
Details  Medically compromised patients.
Patients who had undergone analgesic/steroid therapy or other medication therapy.
Patient who has known history of allergy to any drugs used in the study.
Pregnant or lactating women.
Smokers.
Patient not willing to participate in study or patient not willing to come for post-operative follow-up
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain score via visual analog scale  24 hours, 48 hours and 72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Pain score via visual analog scale, pain intensity scale  24 hours, 48 hours and 72 hours 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   21/11/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Pain has been defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.

Pain felt during minor periodontal procedures are usually unpleasant, dull, throbbing and persistent in nature.

Minor periodontal surgical procedures are invasive procedures in which smaller incisions are made with no extensive damage to the gingival tissues thereby causing lesser chances of infection with a shorter healing period.

Postoperative pain is a predictable event in most cases hence, steps should be taken to minimize the pain and discomfort that the patient experiences after minor periodontal surgical procedures.

Currently local anesthesia and analgesics have made the procedure admirably painless. Concept of using analgesics such as NSAIDs came from its mechanism of action at the site of injury and within the central nervous system. NSAIDs also have a direct analgesic effect that is distinct from their inhibition of prostaglandin formation.

The use of nonsteroidal analgesic has its advantages of adequate pain control, but it has its various disadvantages of causing adverse effects inherent to the medication. These effects include gastric irritations, multiple oral or parenteral analgesic administration, or allergic reactions to the drugs itself. Attempt from the physician’s aspect is to maximize the alleviation of pain and minimizing the adverse effects associated with the drug to look for other alternatives.

One attractive alternative is the use of a topical therapeutic system, known for its efficacy in various medical fields and offering other distinct advantages. Objective of topical analgesic therapy is to attain comparable analgesic effect with fewer adverse effects than oral analgesics. The serum concentration of the drug achieved with topical analgesics is relatively low, and thus systemic effects and drug-drug interaction is reduced. In addition, bypassing the first-pass metabolism considerably reduces the total drug dosage needed.

Ketoprofen, a hydrophilic NSAID with physiochemical property, is widely used both orally and topically for effective pain relief. Various topical formulations of ketoprofen have been studied, including the patch, gel, and solution wherein patches were seen to exhibited more control release.

Transdermal patch of ketoprofen was formulated using four formulas using polyethylene glycol 400, polyvinylpyrrolidone K-30, and ethyl cellulose as the polymer. Transdermal patches of ketoprofen have gained popularity as an effective analgesic due to advantages such as ease of topical application, reduced risk of dose dumping compared to creams, ointments, and gel forms. It also offers advantages like prolonged duration of action, self-administration capability and ease of termination thereby improving the patient’s compliance.

This study is first of its kind which will evaluate the efficacy of transdermal ketoprofen patch in post-operative pain management after minor periodontal procedures.

 
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