- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07618494
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Federal
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Islamabad, Federal, 파키스탄, 44000
- Ayesha Noor
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Islamabad, Federal, 파키스탄, 44000
- School of dentistry
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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:
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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Paracetamol
Participants receive oral paracetamol 1000 mg before pulpal sensibility testing.
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Oral paracetamol 1000mg administered before pulpal sensibility test
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실험적: Ibuprofen
Participants receive oral ibuprofen 400 mg before pulpal sensibility testing
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Oral Ibuprofen 400mg administered before pulpal sensibility testing.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Electric Pulp Test (EPT) Threshold Values
기간: Baseline and 1 hour after drug administration
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Evaluation of changes in pulpal sensibility response thresholds after administration of paracetamol and ibuprofen.
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Baseline and 1 hour after drug administration
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ayesha Noor, MDS tranii, School of dentistry
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- School of dentistry Pumps
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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Pulpal Condition에 대한 임상 시험
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Nordsjaellands HospitalHvidovre University Hospital; Nordstar Medical아직 모집하지 않음
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Kaohsiung Medical University아직 모집하지 않음폐 선암종 | 폐암(진단) | Condition/Disease
Paracetamol에 대한 임상 시험
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Medical University of Warsaw모병췌장 질환 | 통증, 급성 | 췌장염 | 급성 췌장염 | 췌장 질환 | 위장병학 | 소아과폴란드
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Aziende Chimiche Riunite Angelini Francesco S.p.AHippocrates Research종료됨
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Boehringer Ingelheim완전한
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Unither Pharmaceuticals, FranceEXCELYA Bordeaux완전한