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Effect of Common Analgesia on Pulp Sensibility

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07125911
Enrollment
122
Registered
2025-08-15
Start date
2024-04-07
Completion date
2025-04-07
Last updated
2025-08-15

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

Conditions

Irreversible Pulpitis With Apical Periodontitis

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.

Interventions

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

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.

Sponsors

HITEC-Institute of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in pulpal sensibility test results30 minutes after drugMean 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026