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Post Endodontic PainPhase 4PATCH-PAINNCT07610265

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

A Phase 4 study testing Ketoprofen transdermal patch, Fentanyl transdermal patch and Diclofenac sodium tablet in people with Post Endodontic Pain, run by Nims University Rajasthan at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Post Endodontic Pain
What is being tested?
Ketoprofen transdermal patch, Fentanyl transdermal patch and Diclofenac sodium tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteIndia
Study dates
18 Apr 2024to 18 Oct 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
  • 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.
  • Pregnant and lactating women were excluded from the study.
  • Patients with a history of antibiotic use during the study period were also excluded.

Trial locations and contacts

1 site in 1 country.

India1 site
  • Department of Conservative Dentistry and Endodontics, Nims Dental College and Hospital, Nims University, Rajasthan

    Jaipur, Rajasthan, 303121

Other trials in India

About this study

Official title: Comparative Evaluation of Two Different Drugs Administered Using Transdermal Drug Delivery Route Versus Two Oral Tablets in Management of Post-Endodontic Pain

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:

Read more

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.

Read the detailed description

Post-endodontic pain is a common consequence of root canal treatment and is primarily associated with the release of inflammatory mediators in the periapical tissues following instrumentation and obturation. Analgesic medications are routinely prescribed to reduce pain during the immediate postoperative period. Conventional oral administration is effective but may be associated with gastrointestinal adverse effects and variability in drug absorption. Transdermal drug delivery systems provide sustained release of medication through the skin, maintain relatively stable plasma concentrations, and may improve patient compliance while reducing systemic adverse effects.

This randomized, parallel-group clinical trial was conducted to compare the effectiveness of two transdermal medications, fentanyl patch and ketoprofen patch, with two orally administered medications, diclofenac and ibuprofen, in the management of post-endodontic pain. A total of 80 participants undergoing single-sitting root canal treatment were enrolled and randomly allocated into four equal groups of 20 participants each.

Participants in Group I received a transdermal fentanyl patch; Group II received a transdermal ketoprofen patch; Group III received oral diclofenac tablets; and Group IV received oral ibuprofen tablets according to the study protocol. All interventions were administered after completion of endodontic treatment.

The study was designed to determine whether transdermal administration of analgesic agents could provide pain control comparable to or better than conventional oral therapy during the early postoperative period following root canal treatment. The findings were intended to contribute to evidence-based recommendations regarding alternative routes of analgesic administration for the management of post-endodontic pain in clinical endodontic practice.

Being tested
Ketoprofen transdermal patch, Fentanyl transdermal patch, Diclofenac sodium tablet, Ibuprofen Tablet
Keywords
Post-Endodontic Pain, Transdermal Drug Delivery, Root Canal Treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ketoprofen transdermal patchDrug

    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.

  • Fentanyl transdermal patchDrug

    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.

  • Diclofenac sodium tabletDrug

    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.

  • Ibuprofen TabletDrug

    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.

Study groups in NCT07610265
Study groupRoleWhat they receive
Ketoprofen transdermal patchActive comparatorA 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.
Receives: Drug: Ketoprofen transdermal patch
Fentanyl transdermal patchActive comparatorA 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.
Receives: Drug: Fentanyl transdermal patch
Diclofenac sodium tabletActive comparatorDiclofenac 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.
Receives: Drug: Diclofenac sodium tablet
Ibuprofen TabletActive comparatorIbuprofen 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.
Receives: Drug: Ibuprofen Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From immediately after endodontic treatment to 48 hours post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2026
  2. Study start18 Apr 2024
  3. Primary completion18 Oct 2025
  4. Study completion18 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07610265
Sponsor's protocol ID
IEC/P-541/2024
Acronym
PATCH-PAIN
Status last verified
Jun 2026
First submitted
20 May 2026
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared as the study involves patient-level clinical data collected during routine endodontic treatment. To ensure participant confidentiality and privacy, data will remain under the control of the study investigators and will not be made publicly available. Only aggregated and anonymized results will be reported in publications and presentations.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ketoprofen transdermal patch, Fentanyl transdermal patch and Diclofenac sodium tablet in people with Post Endodontic Pain, run by Nims University Rajasthan at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Postoperative Pain Intensity from Baseline to 48 Hours Assessed by Visual Analog Scale (VAS) (time frame: From immediately after endodontic treatment to 48 hours post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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