To compare the efficacy and safety of two different analgesic formulations in the management of pain following extraction of the wisdom teeth that donot erupt properly from both the sides.

A randomised, open label, crossover, comparative study evaluating the efficacy and tolerability of diclofenac(50mg) + paracetamol(500mg) FDC versus Ibuprofen (400mg) in the management of dental pain following impacted third molar extraction.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/08/001966

Enrollment

100

Registered

2011-08-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Patients needing bilateral impacted third molar tooth extraction

Interventions

Intervention1: Fixed Dose Combination of Diclofenac 50mg plus Paracetamol 500mg: One tablet twice daily for three days Control Intervention1: Ibuprofen 400mg: One tablet three times daily for three da

Eligibility

Inclusion criteria

Inclusion criteria: 1 Patients needing bilateral tooth extraction for impacted third molar under local anesthesia 2 Patients between the ages of 18 to 65 years 3 Patients with in general good health- American Society of Anesthesiologists (ASA) status I or II (healthy subjects based upon criteria for safe administration in out-patient of conscious sedation) 4 Patients willing to undergo observation period for four hours post-extraction 5 Patients willing for telephonic follow up 6 Patients with ability to complete a 10 cm visual analog scale(VAS)

Exclusion criteria

Exclusion criteria: 1 Surgical Time in excess of 45 minutes 2 Patients with known hypersensitivity to any of the study drugs 3 Patients with any contraindication to the study drugs 4 Patients who are pregnant or nursing 5 Patients with history of peptic ulcers and/or GI bleeding 6 Patients who have significant psychiatric history 7 Patients with severe kidney/ liver disease 8 Patients who are taking any of the following drugs: ACE inhibitor; potassium sparing diuretics; aspirin on a near daily basis; coumarin or other blood thinners 9 Patients with unusual surgical difficulty (determined from panoramic radiograph or during the actual surgery) 10 Patients developing any complication during or after surgery 11 Patients who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use) within 4 weeks prior to randomization 12 Patient known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency, or psychotic state).

Design outcomes

Primary

Measure	Time frame
Time to onset of analgesia Time to Maximum Pain relief (tMaxPR) Pain relief at 8 hrs (PR8)Timepoint: After administration of the first dose of medication.	—

Secondary

Measure	Time frame
Pain intensity difference at 8 hours (PID8) Time to maximum Pain Intensity Difference(tmaxPID) Pain relief scores at 24, 48, 72 hours (PR24, PR48 , PR72 ) Global efficacy by patients and investigator Rescue analgesia requirementTimepoint: The pain intensity shall be assessed at baseline, 30min, 60 min, 2hr, 4 hr, 6 hr, 8 hr, 24hr, 48hr and on the 4th post extraction day.	—

Countries

India

Contacts

Public ContactDr Sanjay Maroo

Troikaa Pharmaceuticals Limited

medicalservices@troikaapharma.com07926856242

Outcome results

None listed

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