Effect of Common Analgesia on Pulp Sensibility

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.

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Key information

Conditions

Irreversible Pulpitis with Apical Periodontitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hitec Ims

Rawalpindi, Punjab Province, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen 400 mg (if necessary)

Drug

Single oral dose of 400 mg ibuprofen administered in a blinded capsule. Prior to dosing, baseline pulpal sensibility tests (cold test with Endo-Ice and Electric Pulp Test) and pain rating (VAS) will be recorded on a contralateral healthy tooth and the target tooth with symptomatic irreversible pulpitis. The drug is given orally and tests are repeated 30 minutes after ingestion. Participants are monitored for adverse effects. Participants who cannot take NSAIDs are excluded

Paracetamol 500 mg

Drug

A single oral dose of 500 mg paracetamol administered in a blinded capsule. Baseline pulpal sensibility testing (cold test with Endo-Ice and Electric Pulp Test) and pain level assessment using a Visual Analogue Scale (VAS) will be performed on both the tooth with symptomatic irreversible pulpitis and a contralateral healthy tooth prior to administration. The same tests will be repeated 30 minutes after ingestion to evaluate any masking effect on test results.

Primary outcomes

Change in pulpal sensibility test results

Time frame: 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.

Sponsors and collaborators

Lead sponsor

HITEC-Institute of Medical Sciences

Other

Registry information

Official study title

COMPARISON OF THE EFFECT OF COMMON ANALGESICS ON PULPAL SENSIBILITY TESTS: A CLINICAL TRIAL

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Aug 15, 2025
Registry last updated: Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed