Research comparing the effect of transdermal patches of ketoprofen and diclofenac sodium to that of oral diclofenac sodium tablets on pain reduction following single-visit root canal therapy in patients with symptomatic irreversible pulpitis - a randomized clinical trial
- Conditions
- Pulpitis,
- Registration Number
- CTRI/2022/07/044231
- Lead Sponsor
- DR PRIYA PORWAL
- Brief Summary
The present study is conducted to compare the efficacy of ketoprofen and diclofenac sodium transdermal patches with that of oral diclofenac sodium tablets on post-operative pain reduction after single sitting root canal therapy in patients having symptomatic irreversible pulpitis. Results of the study will enable us to determine which route of drug delivery is mosteffective and how effective transdermal patches are in controlling pain. Transdermalpatches minimize or eliminate side effects like gastric discomfort and irritation causedby oral medication. In addition to evaluating the most effective NSAID in controllingpost-operative pain after root canal treatment, this study will also help us evaluate theside effects caused by transdermal patches.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 78
- Patients complaining of pain in anterior or single-rooted premolar teeth of either jaw and diagnosed as symptomatic irreversible pulpitis with or without apical periodontitis having pre operative moderate to severe pain indicated for single visit endodontics will be included in the study.
- A written informed consent will be taken from all the patients and only those patients ready to sign the consent letter will be included in the study.
- Patients with known hypersensitivity against ketoprofen or diclofenac sodium will be excluded from the study.
- patients with history of allergic reactions such as bronchospasm, shock, urticarial, etc., following the use of non-steroidal anti-inflammatory drugs (NSAIDs) will be excluded from the study.
- Patients with high blood pressure and cardiac conditions will be excluded from the study.
- Patients with sinus drainage, pus discharge, acute or chronic apical abscess will be excluded from the study.
- Intentional RCT, fractured tooth having cracks or resorption will be excluded from the study.
- Patients undergoing treatment with other NSAIDs or corticosteroids during the study period will be excluded from the study.
- Patients with developmental anomalies, congenital defects, pathology or open apex, with presence of anatomical obstacles such as calcifications in the canals or any anticipated procedural difficulties related to study teeth will be excluded from the study.
- Pregnant and lactating women will be excluded from the study.
- Patients who have taken NSAIDS or antibiotics within 24 hrs before administration of study drug will be excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method as a outcome of the study, postoperative pain control will be assessed at 4hours, 8hours, 24hours and 48hours after the treatment 4hours, 8hours, 24hours and 48hours
- Secondary Outcome Measures
Name Time Method as a secondary outcome of the study adverse effects of transdermal pain relieving patches and oral analgesics will be assessed during the course of the study i.e., 48h 48 hours
Trial Locations
- Locations (1)
K M Shah dental college and hospital
🇮🇳Vadodara, GUJARAT, India
K M Shah dental college and hospital🇮🇳Vadodara, GUJARAT, IndiaDR PRIYA PORWALPrincipal investigator07899744426piyajain4695@gmail.com