跳至主要内容
临床试验/NCT07618494
NCT07618494已完成不适用

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

Pakistan Institute of Medical Sciences2 个研究点 分布在 1 个国家实际入组 184 人开始时间: 2026年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
184
试验地点
2
主要终点
Change in Electric Pulp Test (EPT) Threshold Values

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
干预性
分配方式
随机
干预模型
平行分组
主要目的
诊断
盲法
双盲 (受试者、研究者)

盲法说明

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Ibuprofen

Experimental

Participants receive oral ibuprofen 400 mg before pulpal sensibility testing

干预措施: Ibuprofen (Drug)

Paracetamol

Experimental

Participants receive oral paracetamol 1000 mg before pulpal sensibility testing.

干预措施: Paracetamol (Drug)

结局指标

主要结局

Change in Electric Pulp Test (EPT) Threshold Values

时间窗: Baseline and 1 hour after drug administration

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

次要结局

未报告次要终点

研究者

申办方类型
其他政府机构
责任方
主要研究者
主要研究者

Ayesha Noor

Principal investigator

Pakistan Institute of Medical Sciences

研究点 (2)

Loading locations...

标识符

NCT 编号
NCT07618494
其他研究编号
School of dentistry Pumps

日期

首次提交
(4个月前)
首次发布
(4个月前)
主要完成日期
(4个月前)
研究完成日期
(4个月前)
最近核实
(5个月前)
最近更新
(4个月前)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
否

Because its my personal

是否有结果
否

相似试验