Elevation of Effect of Common Analgesic on Pulp Sensibility Tet

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.

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.

Study Overview

• Status: Completed
• Conditions: Pulpal Condition
• Intervention / Treatment: Drug: Paracetamol; Drug: Ibuprofen

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.

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Federal
    • Islamabad, Federal, Pakistan, 44000
      • Ayesha Noor
    • Islamabad, Federal, Pakistan, 44000
      • School of dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 6.Sample selection:

Inclusion criteria:

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.

Exclusion Criteria:

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.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paracetamol; Participants receive oral paracetamol 1000 mg before pulpal sensibility testing.	Drug: Paracetamol; Oral paracetamol 1000mg administered before pulpal sensibility test
Experimental: Ibuprofen; Participants receive oral ibuprofen 400 mg before pulpal sensibility testing	Drug: Ibuprofen; Oral Ibuprofen 400mg administered before pulpal sensibility testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Electric Pulp Test (EPT) Threshold Values	Evaluation of changes in pulpal sensibility response thresholds after administration of paracetamol and ibuprofen.	Baseline and 1 hour after drug administration

Collaborators and Investigators

• Sponsor: Pakistan Institute of Medical Sciences
• Investigators: Principal Investigator: Ayesha Noor, MDS tranii, School of dentistry

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Actual): May 5, 2026
• Study Completion (Actual): May 5, 2026

Study Registration Dates

• First Submitted: May 24, 2026
• First Submitted That Met QC Criteria: May 24, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 24, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pulpal a
• Additional Relevant MeSH Terms: Organic Chemicals; Carboxylic Acids; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Acids, Carbocyclic; Phenylpropionates; Acetaminophen; Ibuprofen
• Other Study ID Numbers: School of dentistry Pumps

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Because its my personal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No