Effect of Common Analgesia on Pulp Sensibility

Not Applicable

Completed

• Conditions: Irreversible Pulpitis With Apical Periodontitis
• Interventions: Drug: Ibuprofen 400 mg (if necessary); Drug: Paracetamol 500 mg

• Registration Number: NCT07125911
• Lead Sponsor: HITEC-Institute of Medical Sciences

Brief Summary

his study will investigate whether commonly used analgesics - 400 mg ibuprofen and 500 mg paracetamol - influence the accuracy of pulpal sensibility tests (cold test and electric pulp test) in patients with symptomatic irreversible pulpitis. Analgesics are often taken prior to dental visits and may mask endodontic symptoms, affecting diagnosis. Participants will be randomly assigned to receive either ibuprofen or paracetamol in a double-blind design. Test responses and pain levels will be measured before and 30 minutes after medication to assess any masking effect.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-07
• Primary Completion: 2025-04-07
• Study Completion: 2025-04-07
• Status Verified: 2025-08
• Study First Submitted: 2025-08-11
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Patients with moderate to severe pain due to SIP

Patients with prolonged pain in response to the cold test with Endo-Ice

Patients who had not used any analgesics or CNS depressant during last 6 hours

Males and females aged 18-40

Exclusion Criteria

• patients with American Society of Anesthesiologists physical status>1

who could not take paracetamol and ibuprofen

whose teeth did not respond to the cold test

with toothache due to periapical disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen 400 mg	Ibuprofen 400 mg (if necessary)	Participants will receive a single oral dose of 400 mg ibuprofen. Cold test and electric pulp test (EPT) will be performed on a tooth with symptomatic irreversible pulpitis and on a contralateral healthy tooth before drug administration and 30 minutes after ingestion.
Paracetamol 500 mg	Paracetamol 500 mg	Participants will receive a single oral dose of 500 mg paracetamol. Cold test and electric pulp test (EPT) will be performed on a tooth with symptomatic irreversible pulpitis and on a contralateral healthy tooth before drug administration and 30 minutes after ingestion.

Primary Outcome Measures

Name	Time	Method
Change in pulpal sensibility test results	30 minutes after drug	Mean change from baseline in cold test pain score (Visual Analogue Scale, 0-10) and in Electric Pulp Test (EPT) threshold value for the tooth with symptomatic irreversible pulpitis. Tests performed on the same tooth before dosing and 30 minutes after ingestion.

Trial Locations

Locations (1)

Hitec Ims; 🇵🇰 Rawalpindi, Punjab, Pakistan