Irreversible Pulpitis With Apical PeriodontitisNCT07125911
Effect of Common Analgesia on Pulp Sensibility
A study testing Ibuprofen 400 mg (if necessary) and Paracetamol 500 mg in people with Irreversible Pulpitis With Apical Periodontitis, run by HITEC-Institute of Medical Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irreversible Pulpitis With Apical Periodontitis
- What is being tested?
- Ibuprofen 400 mg (if necessary) and Paracetamol 500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Apr 2024to 7 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARISON OF THE EFFECT OF COMMON ANALGESICS ON PULPAL SENSIBILITY TESTS: A CLINICAL TRIAL
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.
- Being tested
- Ibuprofen 400 mg (if necessary), Paracetamol 500 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Paracetamol 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes after drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start7 Apr 2024
- Primary completion7 Apr 2025
- Study completion7 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible Pulpitis With Apical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- HITEC-Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Kinza Iftikhar, HITEC-Institute of Medical Sciences
- Investigators
- Dr Kinza Iftikhar, BDS, Principal investigator, HITEC-Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125911
- Sponsor's protocol ID
- Dr Kinza Iftikhar
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF THE EFFECT OF COMMON ANALGESICS ON PULPAL SENSIBILITY TESTS: A CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT07125911
- Acronym / sponsor ID
- Dr Kinza Iftikhar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- HITEC-Institute of Medical SciencesUniversity, hospital or other
- Study start
- 7 Apr 2024 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen 400 mg | Experimental | Drug: Ibuprofen 400 mg (if necessary)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. |
| Paracetamol 500 mg | Experimental | Drug: Paracetamol 500 mgParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Ibuprofen 400 mg |
| Paracetamol 500 mgA 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. | Drug | Paracetamol 500 mg |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Kinza Iftikhar, BDS principal investigator
HITEC-Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen 400 mg (if necessary) and Paracetamol 500 mg in people with Irreversible Pulpitis With Apical Periodontitis, run by HITEC-Institute of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pulpal sensibility test results (time frame: 30 minutes after drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.