COMPARISON OF THE EFFECT OF COMMON ANALGESICS ON PULPAL SENSIBILITY TESTS: A CLINICAL TRIAL
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Change in pulpal sensibility test results
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Ibuprofen 400 mg (if necessary) (Drug)
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.
Intervention: Paracetamol 500 mg (Drug)
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Kinza Iftikhar
Dr Kinza
HITEC-Institute of Medical Sciences