Elevation of Effect of Common Analgesic on Pulp Sensibility Tet

NCT07618494 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2026-06-01

No results posted yet for this study

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. 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.

Conditions

  • Pulpal Condition

Interventions

DRUG

Paracetamol

Oral paracetamol 1000mg administered before pulpal sensibility test

DRUG

Ibuprofen

Oral Ibuprofen 400mg administered before pulpal sensibility testing.

Sponsors & Collaborators

  • Pakistan Institute of Medical Sciences

    lead OTHER_GOV

Principal Investigators

  • Ayesha Noor, MDS tranii · School of dentistry

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-05-05
Completion
2026-05-05

Countries

  • Pakistan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07618494 on ClinicalTrials.gov