Effect of Common Analgesia on Pulp Sensibility

NCT07125911 | Completed DMC

• 1 other identifier: Dr Kinza Iftikhar
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Irreversible Pulpitis With Apical Periodontitis

Outcome Measures

Primary Outcomes (1)

• Change in pulpal sensibility test results

  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.

  30 minutes after drug

Study Arms (2)

Ibuprofen 400 mg

EXPERIMENTAL

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.

Drug: Ibuprofen 400 mg (if necessary)

Paracetamol 500 mg

EXPERIMENTAL

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.

Drug: Paracetamol 500 mg

Interventions

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

Ibuprofen 400 mg

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.

Paracetamol 500 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HITEC-Institute of Medical Sciences: lead

Study Sites (1)

Hitec Ims

Rawalpindi, Punjab Province, Pakistan

Location

Related Links

• Related Info

MeSH Terms

Interventions

Ibuprofen; Acetaminophen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Dr Kinza Iftikhar, BDS

  HITEC-Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Kinza

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 15, 2025
• Study Start: April 7, 2024
• Primary Completion: April 7, 2025
• Study Completion: April 7, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)