A study comparing the effect of low-cost and branded pain relief medicines in patients with dental pain

Evaluation of Safety and Efficacy of Generic Versus Branded Generic Formulations of Ibuprofen and Aceclofenac-Paracetamol in Odontogenic Pain: A Randomized Clinical Trial - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100218

Enrollment

160

Registered

2026-01-02

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Health Condition 1: K044- Acute apical periodontitis of pulpal origin Health Condition 2: K040- Pulpitis

Interventions

Intervention1: Jan Aushadhi - IBUPROFEN: Group 1 participants will receive Jan Aushadhi supplied Ibuprofen 400mg oral tablets twice daily (BD) for 5 days as prescribed for management of odontogenic pa

Eligibility

Inclusion criteria

Inclusion criteria: All patients diagnosed with Pulpitis and Acute apical periodontitis having Visual Analog Scale pain score more than or equal to 4 at baseline

Exclusion criteria

Exclusion criteria: 1.Patients requiring surgical intervention under general anaesthesia or other medications except NSAID for treatment of dental pathology 2.Patients with odontogenic -like pain (e.g., referred pain, neuralgia) without a dental pathology 3.Patients with past history of allergic reactions or hypersensitivity to NSAIDs 4.Pregnant or Lactating women 5.Patients currently on chronic NSAIDs (for cardiovascular disease), systemic corticosteroids, opioids, anticoagulants, or immunosuppressants within last 2 months 6.History of Gastrointestinal disorders (e.g. Peptic ulcer disease, bleeding), bronchial asthma, or respiratory distress 7.History of using any NSAID or antibiotics within 2 weeks before the initial OPD visit 8.History of alcohol use disorder or substance abuse

Design outcomes

Primary

Measure	Time frame
The mean change in Visual Analog Scale scoreTimepoint: Baseline, Day 3 and Day 5	—

Secondary

Measure	Time frame
Change in salivary Prostaglandin E2 (PGE2) levelsTimepoint: Baseline (Day 0) and post-treatment (Day 5);Change in serum C-reactive protein (CRP)Timepoint: Baseline (Day 0) and post-treatment (Day 5);Incidence and severity of adverse drug reactionsTimepoint: During treatment period up to Day 5;Changes in hepatic, renal and hematological parametersTimepoint: Baseline and Day 5;Cost effectiveness and incremental cost effectiveness analysisTimepoint: At end of the treatment period;Cost benefit cost minimization and budget impact analysisTimepoint: At end of the study	—

Measure

Time frame

Change in salivary Prostaglandin E2 (PGE2) levelsTimepoint: Baseline (Day 0) and post-treatment (Day 5);Change in serum C-reactive protein (CRP)Timepoint: Baseline (Day 0) and post-treatment (Day 5);Incidence and severity of adverse drug reactionsTimepoint: During treatment period up to Day 5;Changes in hepatic, renal and hematological parametersTimepoint: Baseline and Day 5;Cost effectiveness and incremental cost effectiveness analysisTimepoint: At end of the treatment period;Cost benefit cost minimization and budget impact analysisTimepoint: At end of the study

—

Countries

India

Contacts

Public ContactDr Bala Ashwathy R M

SRM Medical College Hospital & Research Centre, SRM Institute of Science & Technology (SRMIST)

sangeeta1@srmist.edu.in9176630021

Outcome results

None listed

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