AzTrials
AzTrials

Pulpal ConditionNCT07618494

Elevation of Effect of Common Analgesic on Pulp Sensibility Tet

A study testing Paracetamol and Ibuprofen in people with Pulpal Condition, run by Pakistan Institute of Medical Sciences at 2 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Introduction Pulp sensibility tests are essential in endodontic diagnosis because they help determine whether a tooth requires conservative management or irreversible treatment such as root canal therapy. Incorrect interpretation may result in unnecessary treatment or delayed management of irreversible pulpitis. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Pulpal Condition
What is being tested?
Paracetamol and Ibuprofen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
184 participants
Where
2 sitesPakistan
Study dates
1 Feb 2026to 5 May 2026
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 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 6.Sample selection:
  • Healthy adults aged 18-40 years with intact, caries-free maxillary central incisors.
  • Teeth showing normal baseline response to sensibility testing. No use of any analgesic, sedative, or psychotropic medication within the last 24 hours.
  • Participants willing to comply with study procedures and follow-up schedule.

Who cannot join

  • Teeth with restorations, fractures, attrition, or periapical pathology. Patients with systemic diseases influencing pain perception (e.g., diabetes, neuropathy).
  • History of hypersensitivity or contraindication to the tested analgesics. Pregnant or lactating women. Participants with a history of long-term analgesic or corticosteroid use.
  • -

Trial locations and contacts

2 sites in 1 country.

Pakistan2 sites
  • Ayesha Noor

    Islamabad, Federal, 44000

  • School of dentistry

    Islamabad, Federal, 44000

Other trials in Pakistan

About this study

Official title: Elevation of Effect of Common Analgesic on Pulp Sensibility Test .:A Cilinical Trial

Introduction Pulp sensibility tests are essential in endodontic diagnosis because they help determine whether a tooth requires conservative management or irreversible treatment such as root canal therapy. Incorrect interpretation may result in unnecessary treatment or delayed management of irreversible pulpitis. These tests assess neural response indirectly rather than true pulpal blood supply, making them vulnerable to factors that alter pain perception.

Common analgesics such as NSAIDs, paracetamol, and opioids may influence pulpal sensibility test outcomes by modifying nociceptive pathways and pain thresholds. NSAIDs reduce prostaglandin synthesis and peripheral sensitization, whereas paracetamol and opioids act centrally to alter pain perception. Consequently, analgesic intake before testing may produce false-positive or false-negative responses, reducing diagnostic accuracy.

Read more

Rationale of the Study Patients frequently self-medicate with analgesics before dental consultation, which may interfere with pulpal sensibility testing. Despite the widespread clinical use of these tests, there is limited standardized evidence regarding the effect of commonly used analgesics on test responses. This study aims to clarify the influence of analgesics on pulpal sensibility tests and improve diagnostic reliability before irreversible endodontic procedures.

Hypothesis Pre-administration of common analgesics significantly alters pulpal sensibility test responses compared to an analgesic-free condition.

Objective To evaluate the effect of commonly used analgesics on diagnostic response patterns produced by standard pulpal sensibility tests.

Study Design and Methods Study Design: Randomized, double-blind, placebo-controlled clinical trial. Duration: 6 months after ethical approval. Sample Size: 184 participants. Sampling Technique: Non-probability consecutive sampling. Participants: Healthy adults aged 18-40 years with intact, caries-free maxillary central incisors showing normal baseline pulp responses.

Inclusion Criteria Healthy adults aged 18-40 years. Intact maxillary central incisors. Normal baseline pulp sensibility response. No recent use of analgesics or psychotropic drugs. Exclusion Criteria Restored or pathologic teeth. Systemic diseases affecting pain perception. Hypersensitivity to study drugs. Pregnant or lactating women. Long-term analgesic/corticosteroid users. Study Procedure

Participants will be randomly assigned into groups receiving:

Paracetamol 1000 mg Ibuprofen 400 mg Baseline pulp sensibility tests will be performed before drug administration and repeated one hour after administration, corresponding to peak plasma concentration.

Two diagnostic tests will be used:

Cold Test using refrigerant spray. Electric Pulp Test (EPT) using a digital pulp tester.

Primary outcome:

Change in EPT threshold values.

Secondary outcomes:

Changes in cold test response type and response time. Statistical Analysis Data will be analyzed using SPSS version 26.0. Descriptive statistics, Shapiro-Wilk test, paired t-test, one-way ANOVA with Tukey post hoc test, and chi-square test will be used. Statistical significance will be set at p < 0.05.

Read the detailed description

Detailed Description This study is designed to evaluate whether commonly used analgesic medications influence the results of pulpal sensibility tests, which are routinely used in endodontics to assess pulp vitality. Accurate diagnosis of pulpal status is essential because treatment decisions such as conservative monitoring or root canal therapy largely depend upon the interpretation of these tests. Since pulpal sensibility tests evaluate neural response rather than true pulpal blood circulation, their outcomes may be altered by medications that affect pain perception.

Common analgesics such as paracetamol and ibuprofen are frequently self-administered by patients before visiting the dentist. These drugs modify nociceptive pathways and may suppress or alter the patient's response to thermal or electrical stimulation during sensibility testing. Consequently, the clinician may obtain false-negative or delayed responses, increasing the risk of misdiagnosis and inappropriate treatment planning. Despite the widespread clinical use of these medications, there is insufficient standardized evidence regarding their effect on pulpal sensibility testing.

The present study will therefore investigate the effect of commonly used analgesics on the response patterns elicited by standard pulpal sensibility tests. The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial over a period of six months after ethical approval. A total of 184 healthy adult participants aged between 18 and 40 years will be included. Only subjects with intact, caries-free maxillary central incisors demonstrating normal baseline pulpal responses will be selected.

Participants will be randomly allocated into study groups using a computer-generated randomization sequence. Allocation concealment will be maintained through sealed opaque envelopes prepared by an independent researcher. Both the participants and the examiner conducting the pulp sensibility tests will remain blinded to group allocation in order to minimize bias. Identical placebo and drug capsules will be prepared by the institutional pharmacy department.

The study groups will receive commonly used analgesics including paracetamol 1000 mg and ibuprofen 400 mg orally with water under supervision. Baseline pulpal sensibility responses will first be recorded prior to drug administration. Post-drug testing will then be performed one hour after administration, corresponding to the expected peak plasma concentration of the drugs.

Two standardized pulp sensibility tests will be employed:

Cold test using refrigerant spray applied to the tooth surface. Electric pulp test (EPT) using a digital pulp tester. For the cold test, the participant will indicate the onset of sensation or pain, and the response will be categorized as positive, delayed, or absent. Response time will also be recorded using a digital stopwatch. For the electric pulp test, threshold values will be measured twice and averaged to reduce variability.

The primary outcome measure of the study will be the change in electric pulp test threshold values before and after analgesic administration. Secondary outcome measures will include alterations in cold test response type and response time.

Data analysis will be performed using SPSS version 26.0. Quantitative variables will be expressed as mean and standard deviation, whereas categorical variables will be reported as frequencies and percentages. Statistical tests including paired t-test, one-way ANOVA, Tukey post hoc test, chi-square test, and Shapiro-Wilk test will be applied where appropriate. A p-value of less than 0.05 will be considered statistically significant.

The findings of this study are expected to improve understanding regarding the pharmacological influence of analgesics on pulpal sensibility tests and help clinicians interpret diagnostic findings more accurately before making irreversible endodontic treatment decisions.

Being tested
Paracetamol, Ibuprofen
Keywords
Pulpal a

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ParacetamolDrug

    Oral paracetamol 1000mg administered before pulpal sensibility test

  • IbuprofenDrug

    Oral Ibuprofen 400mg administered before pulpal sensibility testing.

Study groups in NCT07618494
Study groupRoleWhat they receive
ParacetamolExperimentalParticipants receive oral paracetamol 1000 mg before pulpal sensibility testing.
Receives: Drug: Paracetamol
IbuprofenExperimentalParticipants receive oral ibuprofen 400 mg before pulpal sensibility testing
Receives: Drug: Ibuprofen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Electric Pulp Test (EPT) Threshold Values

    Evaluation of changes in pulpal sensibility response thresholds after administration of paracetamol and ibuprofen.

    Measured: Baseline and 1 hour after drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2026
  2. Study start1 Feb 2026
  3. Primary completion5 May 2026
  4. Study completion5 May 2026

Resources

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
Model description
this module to define the methods that will be used in this interventional study, including the strategy for assigning participants to intervention(s). * Required * § Required if Study Start Date is on or after January 18, 2017 \[\*\] Conditionally required Primary Purpose \* § Select the option that best describes the aim or goal of the study intervention(s). Diagnostic Study Phase \* Select one. Use "N/A" for trials that do not involve drug or biologic products. Interventional Study Model * Select - Model Description If needed, include additional details about the Interventional Study Model. 1,000 characters allowed Number of Arms \* § Enter the total number of arms participants might be assigned to over the course of the clinical study. Error: Required Field Masking \* § Select all roles that are masked, or select "None (Open Label)." Participant Care Provider Investigator Outcomes Assessor None (Open Label) Masking Description If there are other parties who are ma
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07618494
Sponsor's protocol ID
School of dentistry Pumps
Status last verified
May 2026
First submitted
24 May 2026
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Because its my personal

Questions about this trial

What is this clinical trial studying?

A study testing Paracetamol and Ibuprofen in people with Pulpal Condition, run by Pakistan Institute of Medical Sciences at 2 sites 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 3 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 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Electric Pulp Test (EPT) Threshold Values (time frame: Baseline and 1 hour after drug administration). 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 1 Jun 2026.

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