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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

“Comparative evaluation of efficiency of transdermal patches of ketoprofen and diclofenac sodium with oral diclofenac tablet on post endodontic pain reduction following single visit root canal therapy in symptomatic irreversible pulpitis- A Randomized Clinical Study. ?

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/044231
Enrollment
78
Registered
2022-07-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: diclofenac sodium: zuventus healthcare Ltd, analgesic transdermal patches 100mg one patch per day for two days Intervention2: ketoprofen: zuventus healthcare Ltd, analgesic transdermal

Sponsors

DR PRIYA PORWAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 1. Patients with known hypersensitivity against ketoprofen or diclofenac sodium will be excluded from the study. 2. 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. 3. Patients with high blood pressure and cardiac conditions will be excluded from the study. 4. Patients with sinus drainage, pus discharge, acute or chronic apical abscess will be excluded from the study. 5. Intentional RCT, fractured tooth having cracks or resorption will be excluded from the study. 6. Patients with active stomach or duodenal ulceration within the last 6 months will be excluded from the study. 7. Patients undergoing treatment with other NSAIDs or corticosteroids during the study period will be excluded from the study. 8. 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. 9. Pregnant and lactating women will be excluded from the study. 10. Patients who have taken NSAIDS or antibiotics within 24 hrs before administration of study drug will be excluded from the study

Design outcomes

Primary

MeasureTime frame
as a outcome of the study, postoperative pain control will be assessed at 4hours, 8hours, 24hours and 48hours after the treatmentTimepoint: 4hours, 8hours, 24hours and 48hours

Secondary

MeasureTime frame
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., 48hTimepoint: 48 hours

Countries

India

Contacts

Public ContactDr Priya Porwal

K. M. Shah dental college and hospital

nshah7873@gmail.com09998994299

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 10, 2026