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A clinical trial to study the effects of three drugs, transdermal ketoprofen, transdermal diclofenac and oral ibuprofen in patients with pain after root canal treatment

Analgesic efficacy of transdermal ketoprofen, transdermal diclofenac and oral ibuprofen for post endodontic pain control: A double blinded randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/074879
Enrollment
60
Registered
2024-10-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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: Group 1: Transdermal patch of Ketoprofen 30mg once a day for two days + Multivitamin , multimineral capsule once a day for two days Intervention2: Group 2: Transdermal Diclofenac 100mg

Sponsors

Karthik M
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients complaining of pain in single rooted teeth of either jaw and diagnosed as symptomatic irreversible pulpitis showing prolonged response in electrical pulp tester and / cold test. 2)Selected teeth with intact lamina dura in intraoral periapical radiograph with no periapical radiolucency and absence of anatomical obstacles such as calcifications in the canals with no anticipated procedural difficulties. 3)Selected teeth could be treated endodontically in one visit. 4)Patients who gave the informed consent for the study. 5)Patients with VAS score of =5 (0-10 scale) preoperatively were included in the study.

Exclusion criteria

Exclusion criteria: 1)Patients with hypersensitivity against diclofenac, ketoprofen,ibuprofen 2)Patients with a history of allergic reactions such as bronchospasm, shock, urticaria, etc., following the use of diclofenac or other non steroidal anti inflammatory drugs (NSAIDs). 3)Patients with active stomach or duodenal ulceration within the last 6 months. 4)Patients undergoing treatment with other NSAIDs or corticosteroids during the study period and NSAIDs or corticosteroids taken within 7 days. 5)Patients with a history of systemic diseases such as bronchial asthma, epilepsy, inflammatory bowel disease, severe liver or renal insufficiency, dengue fever, emotional and psychosomatic disorders ,bleeding disorders. 6)Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Post-operative painTimepoint: At 6hrs, 12hrs, 24hrs,48hrs following root canal treatment

Secondary

MeasureTime frame
1)Number of rescue medication tablets taken 2)Adverse effects such as gastric irritation, nausea, vomiting, diarrhoea, dizziness etc and any local irritation due to patch will be advised to be recorded by patientsTimepoint: 2 post-operative days

Countries

India

Contacts

Public ContactDr Amit Jena MDS

S.C.B Dental College and Hospital

amitjena@yahoo.com9437836499

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026