Elevation of Effect of Common Analgesic on Pulp Sensibility Tet

NCT07618494 | Completed

• 1 other identifier: School of dentistry Pumps
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Pulpal a

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Paracetamol

EXPERIMENTAL

Participants receive oral paracetamol 1000 mg before pulpal sensibility testing.

Drug: Paracetamol

Ibuprofen

EXPERIMENTAL

Participants receive oral ibuprofen 400 mg before pulpal sensibility testing

Drug: Ibuprofen

Interventions

Paracetamol DRUG

Oral paracetamol 1000mg administered before pulpal sensibility test

Paracetamol

Ibuprofen DRUG

Oral Ibuprofen 400mg administered before pulpal sensibility testing.

Ibuprofen

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead

Study Sites (2)

Ayesha Noor

Islamabad, Federal, 44000, Pakistan

Location

School of dentistry

Islamabad, Federal, 44000, Pakistan

Location

MeSH Terms

Interventions

Acetaminophen; Ibuprofen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Ayesha Noor, MDS tranii

  School of dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Study drugs and placebo will be identical in appearance. Allocation will be concealed using sealed opaque envelopes. Both participants and investigators performing pulpal testing will be blinded to group assignment
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 1, 2026
• Study Start: February 1, 2026
• Primary Completion: May 5, 2026
• Study Completion: May 5, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)