Tokyo, May 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061652) titled 'Pain Relief Patch Versus Oral Tablet After Root Canal Treatment' on May 22.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - NIMS University, Jaipur, Rajasthan, India

Condition: Condition - Post-Endodontic Pain Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate and compare the analgesic efficacy of transdermal and oral drug delivery systems in the management of post-endodontic pain Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Medicine: Ketoprofen transdermal patch A ketoprofen 30 mg transdermal patch was applied once to intact skin immediately after endodontic treatment in adult patients. The patch was replaced after 24 hours, with a total of two patches used over 48 hours to provide continuous non-steroidal anti-inflammatory analgesia through sustained transdermal drug delivery. Each patch was applied once daily without overlap. Patients were monitored for postoperative pain relief and local skin reactions during the 48-hour follow-up period. Interventions/Control_2 - Medicine: Fentanyl transdermal patch A fentanyl 50-mcg transdermal patch is applied to intact skin immediately after endodontic treatment. The patch was applied once and maintained in place for 48 hours to provide continuous opioid analgesia through controlled systemic transdermal drug delivery. No patch replacement or re-dosing was performed during the study period. Patients were monitored over 48 hours for postoperative pain relief and potential adverse effects such as nausea, dizziness, sedation, or local skin reactions.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1.Patients aged 18 to 60 years 2.Patients diagnosed with symptomatic irreversible pulpitis or symptomatic apical periodontitis Multi-rooted teeth indicated for single-visit root canal treatment 3. Patients experiencing moderate to severe preoperative pain 4. Systemically healthy individuals 5. Patients willing to participate and comply with follow-up protocol Key exclusion criteria - 1. Patients with a known history of hypersensitivity or adverse reactions to diclofenac, ketoprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), including reactions such as bronchospasm, shock, or urticaria, were excluded from the study. 2. Individuals with a history of active gastric or duodenal ulceration within the previous six months were not included. 3. Patients who were currently receiving NSAIDs or corticosteroid therapy during the study period were excluded. 4. Participants with a medical history of systemic conditions such as bronchial asthma, epilepsy, inflammatory bowel disease, severe hepatic or renal impairment, dengue fever, or any psychological or psychiatric disorders were not considered eligible for inclusion. 5. Pregnant and lactating women were excluded from the study. 6. Patients with a history of antibiotic use during the study period were also excluded. Target Size - 80

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2024 Year 03 Month 18 Day Date of IRB - 2024 Year 03 Month 18 Day Anticipated trial start date - 2024 Year 03 Month 18 Day Last follow-up date - 2025 Year 09 Month 18 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070540

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