- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Federal
-
Islamabad, Federal, Pakistán, 44000
- Ayesha Noor
-
Islamabad, Federal, Pakistán, 44000
- School of dentistry
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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:
-
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Paracetamol
Participants receive oral paracetamol 1000 mg before pulpal sensibility testing.
|
Oral paracetamol 1000mg administered before pulpal sensibility test
|
|
Experimental: Ibuprofen
Participants receive oral ibuprofen 400 mg before pulpal sensibility testing
|
Oral Ibuprofen 400mg administered before pulpal sensibility testing.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Electric Pulp Test (EPT) Threshold Values
Periodo de tiempo: Baseline and 1 hour after drug administration
|
Evaluation of changes in pulpal sensibility response thresholds after administration of paracetamol and ibuprofen.
|
Baseline and 1 hour after drug administration
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ayesha Noor, MDS tranii, School of dentistry
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- School of dentistry Pumps
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Pulpal Condition
-
HITEC-Institute of Medical SciencesTerminadoInflamación pulpalPakistán
-
Tokat Gaziosmanpasa UniversityTerminadoDientes primarios | Pulpotomía | Sangrado Pulpal; TinciónPavo
-
Assistance Publique - Hôpitaux de ParisAún no reclutando
-
Kahramanmaras Sutcu Imam UniversityTerminadoAnsiedad | Pulpitis | Estrés psicológico | Dolor dental | Inflamación pulpalTurquía (Türkiye)
-
Ataturk UniversityHealth Institutes of TurkeyActivo, no reclutandoPulpitis | Enfermedad Pulpar Dental | Pulpitis - Irreversible | Exposición pulpar dental | Tapa de pulpa | Inflamación pulpalTurquía (Türkiye)
-
Rutgers, The State University of New JerseyNew Jersey Alliance for Clinical and Translational ScienceReclutamientoPeriodontitis apical | Pulpitis irreversible | Necrosis pulparEstados Unidos
-
taymour abuawwadTerminadoCaries dental | Periodontitis periapical | Odontología Pediatrica | Necrosis pulpar | Pulpectomía del diente primarioTurquía (Türkiye)
Ensayos clínicos sobre Paracetamol
-
University of HelsinkiFoundation for Paediatric Research, FinlandTerminado
-
Thammasat UniversityAún no reclutandoAnalgesia postoperatoria | Amigdalectomía con o sin adenoidectomíaTailandia
-
Al-Quds UniversityTerminadoConducto arterioso permeable en bebés prematuros | Conducto arterioso permeable después del parto prematuro | Conducto arterioso permeable en lactantes prematuros | Conducto Arterioso Persistente (PDA)Territorios palestinos
-
Cairo UniversityReclutamientoEfectos Hemodinámicos del Paracetamol Intravenoso en Pacientes Sometidos a Laparotomía de EmergenciaHipotensión inducida por fármacos | Paracetamol | Cirugía de emergenciaEgipto
-
GlaxoSmithKlineTerminado
-
University of OxfordDesconocido
-
Wake Forest University Health SciencesAún no reclutandoEficacia analgésicaEstados Unidos
-
GlaxoSmithKlineTerminado
-
PfizerReclutamientoObesidad | Exceso de peso | Sobrepeso y/o obesidad | La interacción de drogasEstados Unidos
-
Muhammad Aamir LatifAún no reclutando