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
|
|
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
|
|
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
|
|
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. |