Effect of Common Analgesia on Pulp Sensibility

NCT ID: NCT07125911

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-07

Study Completion Date

2025-04-07

Brief Summary

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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

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Conditions

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Irreversible Pulpitis With Apical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ibuprofen 400 mg

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.

Group Type EXPERIMENTAL

Ibuprofen 400 mg (if necessary)

Intervention Type 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

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.

Group Type EXPERIMENTAL

Paracetamol 500 mg

Intervention Type 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.

Interventions

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Ibuprofen 400 mg (if necessary)

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

Intervention Type DRUG

Paracetamol 500 mg

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HITEC-Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Dr Kinza Iftikhar

Dr Kinza

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr Kinza Iftikhar, BDS

Role: PRINCIPAL_INVESTIGATOR

HITEC-Institute of Medical Sciences

Locations

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Hitec Ims

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Related Links

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Other Identifiers

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Dr Kinza Iftikhar

Identifier Type: -

Identifier Source: org_study_id

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