- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07608939
Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers (PO-Pain)
Comparison of Postoperative Pain Following Root Canal Treatment Using AH Plus, ProRoot Bio Sealer, and BC Sealer Ion+: A Randomized Clinical Trial
This prospective randomized clinical trial aims to compare the effects of three different root canal sealers-AH Plus, ProRoot Bio Sealer, and BC Sealer ion+-on postoperative pain following root canal treatment in patients diagnosed with asymptomatic irreversible pulpitis.
Postoperative pain is a common complication after endodontic treatment and may be influenced by microbial, chemical, and mechanical factors. The type and composition of root canal sealer may also affect tissue response, inflammation, and pain levels. AH Plus is an epoxy resin-based sealer known for its sealing ability and dimensional stability, whereas ProRoot Bio Sealer and BC Sealer ion+ are bioceramic sealers with enhanced bioactive properties. BC Sealer ion+ additionally releases both calcium and magnesium ions, which may improve tissue healing and biological performance.
The study will include patients aged 18-60 years presenting with asymptomatic irreversible pulpitis in mandibular first or second molars. Following ethical approval from the European University of Lefke Ethics Committee, approximately 135 patients will be enrolled and randomly assigned into three equal groups according to the root canal sealer used. Sample size calculation was performed using G*Power software with 80% statistical power and a significance level of 0.05.
All treatments will be completed in a single visit by the same experienced clinician under standardized clinical conditions. Root canal preparation will be performed using the ProTaper Universal rotary system with standardized irrigation protocols including sodium hypochlorite, EDTA, chlorhexidine, and sonic activation. Obturation will be completed using a modified single-cone technique with the assigned root canal sealer.
Patients and the outcome assessor will be blinded to group allocation. Postoperative pain will be assessed using the Numeric Rating Scale (NRS) at 6, 12, 24, 48, and 72 hours, as well as on day 7 after treatment. Secondary outcomes will include analgesic consumption and flare-up incidence. All patients will be prescribed ibuprofen to use only if necessary, and analgesic intake will be recorded.
The primary objective of this study is to determine whether different root canal sealers significantly influence postoperative pain levels after root canal treatment. The null hypothesis states that there will be no statistically significant difference among AH Plus, ProRoot Bio Sealer, and BC Sealer ion+ regarding postoperative pain outcomes. Data will be analyzed using appropriate statistical methods, with a significance level set at P < 0.05.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Postoperative pain following root canal treatment remains one of the most important factors affecting patient comfort and perceived treatment success in endodontics. The occurrence and intensity of postoperative pain may be influenced by several factors, including instrumentation techniques, irrigation protocols, extrusion of debris or filling materials into periapical tissues, and the physicochemical properties of root canal sealers. Bioceramic sealers have gained increasing popularity because of their bioactivity, biocompatibility, antibacterial properties, and potential to enhance periapical healing. However, limited clinical evidence is available regarding their influence on postoperative pain when compared with conventional epoxy resin-based sealers.
This prospective randomized clinical trial is designed to evaluate and compare postoperative pain levels after root canal treatment performed using three different root canal sealers: AH Plus, ProRoot Bio Sealer, and BC Sealer ion+. The study will include adult patients diagnosed with asymptomatic irreversible pulpitis in mandibular first or second molars requiring primary root canal treatment. All clinical procedures will be performed in a standardized manner by a single experienced clinician to minimize operator-related variability.
Root canal preparation will be completed using the ProTaper Universal rotary instrumentation system under standardized irrigation and disinfection protocols. Canal irrigation will include sodium hypochlorite, EDTA, chlorhexidine, and sonic activation procedures. Obturation will be carried out using a modified single-cone technique with gutta-percha cones corresponding to the final preparation size and the allocated root canal sealer. Randomization will be performed using computer-generated allocation, and allocation concealment will be ensured with sealed opaque envelopes. The study will follow a single-blind design in which participants and outcome assessors remain unaware of group assignment.
AH Plus is an epoxy resin-based sealer widely used because of its dimensional stability, sealing ability, and long-term clinical performance. ProRoot Bio Sealer is a calcium silicate-based bioceramic sealer with enhanced bioactive cement content and a flexible delivery system designed to improve handling and material placement. BC Sealer ion+ is an Akermanite-based premixed bioceramic sealer capable of releasing both calcium and magnesium ions, which may contribute to improved tissue healing, stem cell differentiation, and prolonged bioactivity. Structural differences between conventional calcium silicate materials and Akermanite-based formulations may influence ion release kinetics and tissue responses, potentially affecting postoperative symptoms.
Postoperative pain intensity will be recorded using the Numeric Rating Scale (NRS) at predetermined postoperative intervals. Analgesic intake and flare-up incidence will also be monitored throughout the follow-up period. Statistical analysis will be performed using appropriate parametric or non-parametric tests according to data distribution, with statistical significance established at P < 0.05. The findings of this study may contribute to a better understanding of the clinical performance of contemporary bioceramic sealers and their potential influence on postoperative pain management in endodontic treatment.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Patient Selection Patients will be selected from individuals referred to the Dental Clinic for root canal treatment. Only mandibular first or second molars diagnosed with asymptomatic irreversible pulpitis will be included in the study. Asymptomatic irreversible pulpitis is defined as inflamed vital pulp tissue without clinical symptoms, usually caused by caries, caries excavation, or trauma.
Before treatment, written and verbal informed consent will be obtained from all participants. An online questionnaire including the Numeric Rating Scale (NRS) and the number of analgesics taken will be electronically sent to the participants. Patients will subsequently be contacted by telephone and asked to complete the questionnaire online. Submitted responses will not be modifiable after completion. The primary outcome will be postoperative pain, while secondary outcomes will include analgesic consumption and flare-up incidence.
Inclusion Criteria
- Asymptomatic teeth showing delayed positive responses to thermal testing (EndoIce; Coltene/Whaledent Inc.) and electric pulp testing (Parkell)
- Teeth with extensive pulp exposure during caries excavation
- Inflamed pulp tissue in which bleeding cannot be controlled within 5 minutes
- Periodontally healthy, mature mandibular first or second molars Exclusion Criteria
Patients presenting with the following conditions will be excluded from the study:
- Diabetes mellitus, immunocompromised conditions, or pregnancy
- Use of antibiotics within the last month or requirement for antibiotic prophylaxis
- Use of analgesics within 7 days prior to treatment
- Allergy to any material used during root canal treatment
- Teeth suitable for vital pulp therapy in which bleeding can be controlled within 5 minutes
- Non-vital or symptomatic teeth
- Presence of radiographically detectable periapical lesions
- Teeth requiring post-core restorations or prosthetic support
- Calcified root canals, root resorption, or immature teeth
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: AH Plus Sealer Group
Participants assigned to this group will undergo standardized single-visit root canal treatment using the ProTaper Universal rotary instrumentation system.
Root canal obturation will be performed using gutta-percha cones and AH Plus epoxy resin-based root canal sealer with a modified single-cone obturation technique.
|
AH Plus is an epoxy resin-based root canal sealer used during obturation with a modified single-cone technique.
The material is characterized by high dimensional stability, good sealing ability, low solubility, and adhesion to dentin and gutta-percha.
Root canal treatment procedures, instrumentation protocol, irrigation regimen, and obturation technique will be standardized for all participants.
|
|
Experimental: ProRoot Bio Sealer Group
Participants assigned to this group will undergo standardized single-visit root canal treatment using the ProTaper Universal rotary instrumentation system.
Root canal obturation will be performed using gutta-percha cones and ProRoot Bio Sealer calcium silicate-based bioceramic sealer with a modified single-cone obturation technique.
|
ProRoot Bio Sealer is a calcium silicate-based bioceramic root canal sealer used during obturation with a modified single-cone technique.
The material contains bioactive cement components designed to promote hydroxyapatite formation and maintain an alkaline environment.
The study will use standardized instrumentation, irrigation, and obturation protocols identical to the other intervention groups.
|
|
Experimental: BC Sealer ion+ Group
Participants assigned to this group will undergo standardized single-visit root canal treatment using the ProTaper Universal rotary instrumentation system.
Root canal obturation will be performed using gutta-percha cones and BC Sealer ion+ Akermanite-based bioceramic root canal sealer with a modified single-cone obturation technique.
|
BC Sealer ion+ is an Akermanite-based premixed bioceramic root canal sealer used during obturation with a modified single-cone technique.
The material releases calcium and magnesium ions and is designed to enhance bioactivity and tissue healing potential.
All other clinical procedures, including instrumentation, irrigation, and restoration protocols, will remain standardized across study groups.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Postoperative Pain Intensity
Periodo de tiempo: 6, 12, 24, 48, and 72 hours, and 7 days after treatment
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Postoperative pain intensity following root canal treatment will be evaluated using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (unbearable pain).
Pain scores will be recorded by participants at predetermined postoperative intervals.
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6, 12, 24, 48, and 72 hours, and 7 days after treatment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Analgesic Consumption
Periodo de tiempo: From completion of treatment until 7 days postoperatively
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The number and frequency of analgesic tablets used by participants after treatment will be recorded throughout the follow-up period.
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From completion of treatment until 7 days postoperatively
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- BAYEK061.21
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.
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Ensayos clínicos sobre Pulpitis iriversible
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Cairo UniversityAún no reclutandoPulpitis - Reversible | Pulpitis - Irreversible
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Mansoura UniversityTerminadoPulpitis irreversible | Pulpitis reversibleEgipto
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Tehran University of Medical SciencesActivo, no reclutandoPulpitis irreversible sintomática (SIP) | Pulpitis Irreversible Sintomática Con Periodontitis ApicalIrán
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Urooj FatimaAún no reclutandoPulpitis irreversible sintomática | Pulpitis irreversible | Pulpitis irreversible asintomáticaPakistán
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Jamia Millia IslamiaAún no reclutando
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Cairo UniversityAún no reclutandoPulpitis irreversibleEgipto
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Minia UniversityAún no reclutandoPulpitis irreversibleEgipto
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Chulalongkorn UniversityAún no reclutando
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Sirawut Hiran-usChulalongkorn UniversityActivo, no reclutandoPulpitis - IrreversibleTailandia
-
College of Physicians and Surgeons PakistanActivo, no reclutando
Ensayos clínicos sobre AH Plus Root Canal Sealer
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Kafrelsheikh UniversityReclutamiento
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Ankara Yildirim Beyazıt UniversityActivo, no reclutandoPeriodontitis apical | Obturación del conducto radicularTurquía (Türkiye)
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Cukurova UniversityTerminadoDientes tratados con endodoncia
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Gulf Medical UniversityTerminadoPulpitis irreversibleEmiratos Árabes Unidos
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Ministry of Health, KuwaitKuwait Institute for Medical SpecializationInscripción por invitaciónPeriodontitis periapical | Enfermedades periapicales | Infección del conducto radicularKuwait
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Medipol UniversityTerminadoTratamiento de conductoTurquía (Türkiye)
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Jaweria Gul KeyaniAún no reclutandoDolor Postoperatorio, Agudo | Pulpitis irreversiblePakistán
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National University Hospital, SingaporeActivo, no reclutandoObturación del conducto radicularSingapur
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Tehran University of Medical SciencesActivo, no reclutandoPulpitis irreversible sintomática (SIP) | Pulpitis Irreversible Sintomática Con Periodontitis ApicalIrán
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AZİZ ŞAHİN ERDOĞANTerminadoPeriodontitis apical asintomáticaTurquía (Türkiye)