Comparative Evaluation of Transdermal and Oral Drugs for Management of Post-Endodontic Pain

NCT07610265 | Completed Phase 4

• 1 other identifier: IEC/P-541/2024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial evaluated whether two drugs delivered through transdermal drug delivery systems reduced post-endodontic pain as effectively as two orally administered medications in adult patients undergoing root canal treatment. The study also compared how effectively these medications controlled pain during the first 48 hours after treatment. The study aimed to answer the following questions: Did transdermal drug delivery systems provide pain relief comparable to or better than orally administered medications after endodontic treatment? Did pain intensity differ among the four treatment groups as measured using the Visual Analog Scale (VAS)? The investigators compared two transdermal drug groups with two oral drug groups to identify the treatment that provided better control of post-endodontic pain. Participants: Underwent root canal treatment for symptomatic irreversible pulpitis. Received one of four analgesic interventions consisting of two transdermal patches or two oral medications. Recorded pain intensity using the Visual Analog Scale (VAS) at 6, 12, 24, and 48 hours after treatment.

Conditions

Post Endodontic Pain

Keywords

Post-Endodontic Pain; Transdermal Drug Delivery; Root Canal Treatment

Outcome Measures

Primary Outcomes (1)

• Change in Postoperative Pain Intensity from Baseline to 48 Hours Assessed by Visual Analog Scale (VAS)

  Postoperative pain intensity was assessed as the primary outcome using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Pain scores were recorded at predefined time intervals following endodontic treatment, including baseline (immediately after the procedure) and at 6, 12, 24, and 48 hours postoperatively. Data were collected via patient self-report, primarily through telephone follow-up. The primary endpoint for analysis was the pain intensity at 48 hours after treatment, comparing the effectiveness of the four analgesic interventions in reducing postoperative endodontic pain.

  From immediately after endodontic treatment to 48 hours post-treatment

Study Arms (4)

Ketoprofen transdermal patch

ACTIVE COMPARATOR

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.

Drug: Ketoprofen transdermal patch

Fentanyl transdermal patch

ACTIVE COMPARATOR

A 25 mcg fentanyl transdermal patch was applied once to intact skin immediately after endodontic treatment in adult patients. The patch was 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 during the 48-hour follow-up for postoperative pain relief and potential adverse effects such as nausea, dizziness, sedation, and local skin reactions.

Drug: Fentanyl transdermal patch

Diclofenac sodium tablet

ACTIVE COMPARATOR

Diclofenac sodium 50 mg tablet was administered orally every 8 hours for 48 hours following endodontic treatment in adult patients. The drug was given at a standard therapeutic dose for postoperative analgesia and anti-inflammatory effect. No additional routine analgesics were provided unless rescue medication was required. Patients were monitored over the 48-hour period for pain relief and potential adverse effects such as gastric irritation, nausea, or dizziness.

Drug: Diclofenac sodium tablet

Ibuprofen Tablet

ACTIVE COMPARATOR

Ibuprofen 400 mg tablet was administered orally every 8 hours for 48 hours following endodontic treatment in adult patients for postoperative pain management. The drug was given at standard therapeutic dosing for analgesic and anti-inflammatory effects. No routine additional analgesics were provided unless rescue medication was required. Patients were monitored over the 48-hour period for pain relief and potential adverse effects such as gastric irritation, nausea, or dizziness.

Drug: Ibuprofen Tablet

Interventions

Ketoprofen transdermal patch DRUG

A ketoprofen 30 mg transdermal patch is applied to intact skin immediately after a single-sitting endodontic treatment. 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 any local skin reactions during the 48-hour follow-up period.

Ketoprofen transdermal patch

Fentanyl transdermal patch DRUG

A fentanyl 25-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.

Fentanyl transdermal patch

Diclofenac sodium tablet DRUG

A diclofenac sodium 50 mg tablet was administered orally every 8 hours for 48 hours following endodontic treatment in adult patients. The drug was given at standard therapeutic dosages for postoperative analgesia. No additional analgesics were routinely provided unless rescue medication was required. Patients were monitored during the 48-hour period for pain relief and potential adverse effects such as gastric discomfort, nausea, or dizziness.

Diclofenac sodium tablet

Ibuprofen Tablet DRUG

An ibuprofen 400 mg tablet was administered orally every 8 hours for 48 hours following endodontic treatment for postoperative pain management. The drug was given at standard therapeutic dosages as an analgesic and anti-inflammatory agent. No routine additional analgesics were provided unless rescue medication was required. Patients were monitored over the 48-hour period for pain relief and potential adverse effects such as gastric irritation, nausea, or dizziness.

Ibuprofen Tablet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18 to 60 years
• Patients diagnosed with symptomatic irreversible pulpitis or symptomatic apical periodontitis
• Multi-rooted teeth indicated for single-visit root canal treatment
• Patients experiencing moderate to severe preoperative pain
• Systemically healthy individuals
• Patients willing to participate and comply with follow up protocol

You may not qualify if:

• 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.
• Individuals with a history of active gastric or duodenal ulceration within the previous six months were not included.
• Patients who were currently receiving NSAIDs or corticosteroid therapy during the study period were excluded.
• Pregnant and lactating women were excluded from the study.
• Patients with a history of antibiotic use during the study period were also excluded.

Sponsors & Collaborators

• Nims University Rajasthan: lead

Study Sites (1)

Department of Conservative Dentistry and Endodontics, Nims Dental College and Hospital, Nims University, Rajasthan

Jaipur, Rajasthan, 303121, India

Location

MeSH Terms

Interventions

Diclofenac; Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Phenylpropionates

Study Officials

• CHITRA KUMARI, MDS(pursuing)

  NIMS DENTAL COLLEGE AND HOSPITAL, NIMS UNIVERSITY, RAJASTHAN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Although the study was open-label due to differences in intervention forms, outcome assessment at 48 hours was conducted via telephone by an assessor blinded to treatment allocation using standardized pain scoring methods.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Student

Model Details: This study is a randomized, parallel-group interventional clinical trial. A total of 80 participants were enrolled and randomly allocated into four equal groups (n=20 per group). The study evaluated and compared the analgesic efficacy of the transdermal fentanyl patch, transdermal ketoprofen patch, oral diclofenac, and oral ibuprofen in the management of post-endodontic pain. Each participant received a single assigned intervention without crossover. Pain intensity and treatment response were assessed at predefined postoperative time intervals during short-term follow-up.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: April 18, 2024
• Primary Completion: October 18, 2025
• Study Completion: October 18, 2025
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)