Efficacy of transdermal vs oral ketoprofen in minor periodontal surgical procedure

Not yet recruiting

Conditions: Systemic healthy patients with indicated for minor periodontal surgical procedures

Registration Number: CTRI/2022/11/047485

Lead Sponsor: Dr Vinita Krishna

Brief Summary: Pain has been defined as an unpleasant sensory and emotional experienceassociated with actual or potential tissue damage or described in terms of suchdamage.

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

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

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

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

The use of nonsteroidal analgesic has its advantages of adequate paincontrol, but it has its various disadvantages of causing adverse effectsinherent to the medication. These effects include gastric irritations, multipleoral or parenteral analgesic administration, or allergic reactions to the drugsitself. Attempt from the physicianâ€™s aspect is to maximize the alleviation ofpain and minimizing the adverse effects associated with the drug to look forother alternatives.

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

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

Transdermal patch of ketoprofen was formulated using four formulas usingpolyethylene glycol 400, polyvinylpyrrolidone K-30, and ethyl cellulose as thepolymer. Transdermal patches of ketoprofen have gained popularity as aneffective analgesic due to advantages such as ease of topical application, reducedrisk of dose dumping compared to creams, ointments, and gel forms. It alsooffers advantages like prolonged duration of action, self-administrationcapability and ease of termination thereby improving the patientâ€™s compliance.

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

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.

Exclusion Criteria

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.
Patient not willing to participate in study or patient not willing to come for post-operative follow-up.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain score via visual analog scale	24 hours, 48 hours and 72 hours

Secondary Outcome Measures

Name	Time	Method
Pain score via visual analog scale, pain intensity scale	24 hours, 48 hours and 72 hours

Trial Locations

Locations (1): KLE VK Institute of dental sciences
🇮🇳
Belgaum, KARNATAKA, India
KLE VK Institute of dental sciences
🇮🇳Belgaum, KARNATAKA, India
Dr Vinita krishna
Principal investigator
08860533630
k.vinita1995@gmail.com