Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Effect of Submucosal Cryotherapy With or Without Different Anti-inflammatory Drugs on Postoperative Pain and Interleukin-6 Levels in Maxillary Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Study
Pain after root canal treatment is a common problem, particularly in teeth with symptomatic irreversible pulpitis, a condition involving severe inflammation of the tissue inside the tooth. Submucosal cryotherapy, which involves applying cold saline through an injection near the affected tooth, may help reduce postoperative pain and inflammation. Anti-inflammatory medications, such as diclofenac sodium and dexamethasone, may also provide pain relief.
This randomized clinical trial aims to evaluate the effects of submucosal cryotherapy, alone or combined with anti-inflammatory medications, on postoperative pain and interleukin-6 (IL-6) levels in patients undergoing root canal treatment of upper molars with symptomatic irreversible pulpitis.
A total of 90 adult patients will be randomly assigned to six groups: local anesthesia alone, cryotherapy with anesthesia, diclofenac sodium with anesthesia, dexamethasone with anesthesia, cryotherapy combined with diclofenac sodium, or cryotherapy combined with dexamethasone. All participants will undergo standardized single-visit root canal treatment.
Postoperative pain will be evaluated during the first 72 hours after treatment. IL-6, a substance involved in inflammation, will be measured in blood samples collected from the dental pulp during treatment. The need for additional pain medication and the occurrence of postoperative flare-ups will also be assessed.
The study seeks to determine whether combining submucosal cryotherapy with anti-inflammatory medications provides greater postoperative pain relief than individual interventions or standard care alone.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Hisham E El- Sayed, MSc
- Número de teléfono: +2 0 10 92192763
- Correo electrónico: hesham_elsayed@dent.suez.edu.eg
Ubicaciones de estudio
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Ismailia Governorate
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Ismailia, Ismailia Governorate, Egipto, 41522
- Endodontics Department, Faculty of Dentistry, Suez Canal University
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Contacto:
- Hisham E El- Sayed, MSc
- Número de teléfono: +2 0 10 92192763
- Correo electrónico: hesham_elsayed@dent.suez.edu.eg
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adult patients aged 21-50 years.
- Maxillary first or second molars diagnosed with symptomatic irreversible pulpitis.
- Teeth with mature roots and normal apical tissues or without radiographic evidence of apical pathosis.
- Vital teeth exhibiting an exaggerated and lingering response to thermal stimuli.
- Patients experiencing moderate to severe preoperative pain.
- Patients classified as American Society of Anesthesiologists (ASA) physical status I or II.
- Teeth considered restorable and suitable for rubber dam isolation.
Exclusion Criteria:
- Patients with known hypersensitivity or allergy to articaine, diclofenac sodium, dexamethasone, or any materials used in the study.
- Patients who have received analgesics, anti-inflammatory drugs, corticosteroids, or antibiotics within the preceding 48-72 hours.
- Pregnant or lactating women.
- Medically compromised patients or those receiving immunosuppressive therapy.
- Teeth with periapical lesions, swelling, sinus tracts, tenderness to percussion, or symptomatic apical periodontitis.
- Previously initiated or previously treated teeth.
- Teeth with periodontal pockets, root resorption, calcified canals, or non-restorable coronal structures.
- Cases involving procedural complications, including perforation, instrument separation, or inability to complete root canal treatment according to the standardized protocol.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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Comparador activo: Anesthesia Alone (Control Group)
Participants will receive local anesthesia using one carpule of 4% articaine hydrochloride with epinephrine 1:100,000 administered by buccal infiltration, with supplemental palatal infiltration if needed. Standardized single-visit root canal treatment will be performed without additional submucosal cryotherapy or anti-inflammatory drug injections. |
Local anesthesia will be administered using one carpule of 4% articaine hydrochloride with epinephrine 1:100,000 by buccal infiltration before single-visit root canal treatment. Supplemental palatal infiltration will be provided if needed, and any additional anesthetic administration will be recorded. This standard anesthetic regimen will be used in all six study groups. |
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Experimental: Submucosal Cryotherapy With Anesthesia
Participants will receive standard local anesthesia followed by a single submucosal injection of 1 mL cold normal saline (2-5°C) into the buccal vestibule adjacent to the affected maxillary molar before standardized single-visit root canal treatment. |
Local anesthesia will be administered using one carpule of 4% articaine hydrochloride with epinephrine 1:100,000 by buccal infiltration before single-visit root canal treatment. Supplemental palatal infiltration will be provided if needed, and any additional anesthetic administration will be recorded. This standard anesthetic regimen will be used in all six study groups. Submucosal cryotherapy will be performed through a single injection of 1 mL sterile normal saline cooled to 2-5°C into the buccal vestibule adjacent to the affected maxillary molar before root canal treatment. The intervention is intended to provide localized cooling to reduce postoperative inflammation and pain. Cryotherapy will be administered alone or in combination with an anti-inflammatory drug according to group allocation. |
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Experimental: Diclofenac Sodium With Anesthesia
Participants will receive standard local anesthesia followed by a single submucosal injection of 1 mL diclofenac sodium (25 mg/mL; total dose 25 mg) into the buccal vestibule adjacent to the affected maxillary molar before standardized single-visit root canal treatment. |
Local anesthesia will be administered using one carpule of 4% articaine hydrochloride with epinephrine 1:100,000 by buccal infiltration before single-visit root canal treatment. Supplemental palatal infiltration will be provided if needed, and any additional anesthetic administration will be recorded. This standard anesthetic regimen will be used in all six study groups. Diclofenac sodium will be administered as a single preoperative submucosal injection of 1 mL at a concentration of 25 mg/mL (total dose: 25 mg) into the buccal vestibule adjacent to the affected maxillary molar. It will be administered alone or in combination with submucosal cryotherapy according to group allocation to evaluate its effects on postoperative pain and inflammatory response. |
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Experimental: Dexamethasone With Anesthesia
Participants will receive standard local anesthesia followed by a single submucosal injection of 1 mL dexamethasone sodium phosphate (4 mg/mL; total dose 4 mg) into the buccal vestibule adjacent to the affected maxillary molar before standardized single-visit root canal treatment. |
Local anesthesia will be administered using one carpule of 4% articaine hydrochloride with epinephrine 1:100,000 by buccal infiltration before single-visit root canal treatment. Supplemental palatal infiltration will be provided if needed, and any additional anesthetic administration will be recorded. This standard anesthetic regimen will be used in all six study groups. Dexamethasone sodium phosphate will be administered as a single preoperative submucosal injection of 1 mL at a concentration of 4 mg/mL (total dose: 4 mg) into the buccal vestibule adjacent to the affected maxillary molar. It will be administered alone or in combination with submucosal cryotherapy according to group allocation to evaluate its effects on postoperative pain and inflammatory response. |
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Experimental: Submucosal Cryotherapy With Diclofenac Sodium
Participants will receive standard local anesthesia followed by submucosal administration of cold normal saline (1 mL at 2-5°C) and diclofenac sodium (1 mL at 25 mg/mL) into the buccal vestibule adjacent to the affected maxillary molar before standardized single-visit root canal treatment. The interventions will be administered separately or sequentially according to the finalized study protocol. |
Local anesthesia will be administered using one carpule of 4% articaine hydrochloride with epinephrine 1:100,000 by buccal infiltration before single-visit root canal treatment. Supplemental palatal infiltration will be provided if needed, and any additional anesthetic administration will be recorded. This standard anesthetic regimen will be used in all six study groups. Submucosal cryotherapy will be performed through a single injection of 1 mL sterile normal saline cooled to 2-5°C into the buccal vestibule adjacent to the affected maxillary molar before root canal treatment. The intervention is intended to provide localized cooling to reduce postoperative inflammation and pain. Cryotherapy will be administered alone or in combination with an anti-inflammatory drug according to group allocation. Diclofenac sodium will be administered as a single preoperative submucosal injection of 1 mL at a concentration of 25 mg/mL (total dose: 25 mg) into the buccal vestibule adjacent to the affected maxillary molar. It will be administered alone or in combination with submucosal cryotherapy according to group allocation to evaluate its effects on postoperative pain and inflammatory response. |
|
Experimental: Submucosal Cryotherapy With Dexamethasone
Participants will receive standard local anesthesia followed by submucosal administration of cold normal saline (1 mL at 2-5°C) and dexamethasone sodium phosphate (1 mL at 4 mg/mL) into the buccal vestibule adjacent to the affected maxillary molar before standardized single-visit root canal treatment. The interventions will be administered separately or sequentially according to the finalized study protocol. |
Local anesthesia will be administered using one carpule of 4% articaine hydrochloride with epinephrine 1:100,000 by buccal infiltration before single-visit root canal treatment. Supplemental palatal infiltration will be provided if needed, and any additional anesthetic administration will be recorded. This standard anesthetic regimen will be used in all six study groups. Submucosal cryotherapy will be performed through a single injection of 1 mL sterile normal saline cooled to 2-5°C into the buccal vestibule adjacent to the affected maxillary molar before root canal treatment. The intervention is intended to provide localized cooling to reduce postoperative inflammation and pain. Cryotherapy will be administered alone or in combination with an anti-inflammatory drug according to group allocation. Dexamethasone sodium phosphate will be administered as a single preoperative submucosal injection of 1 mL at a concentration of 4 mg/mL (total dose: 4 mg) into the buccal vestibule adjacent to the affected maxillary molar. It will be administered alone or in combination with submucosal cryotherapy according to group allocation to evaluate its effects on postoperative pain and inflammatory response. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Postoperative Pain Intensity Assessed Using the Numeric Rating Scale (NRS)
Periodo de tiempo: At 6, 12, 24, 48, and 72 hours after root canal treatment.
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Postoperative pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Participants will record their pain intensity at predefined postoperative intervals, and NRS scores will be compared among the six study groups. |
At 6, 12, 24, 48, and 72 hours after root canal treatment.
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Interleukin-6 (IL-6) Levels in Pulpal Blood
Periodo de tiempo: During root canal treatment, immediately after access cavity opening (single intraoperative sample).
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Interleukin-6 (IL-6) levels will be measured in pulpal blood samples collected under aseptic conditions after access cavity opening during root canal treatment. Samples will be stored at -20°C and analyzed using enzyme-linked immunosorbent assay (ELISA). IL-6 levels will be compared among the six study groups to evaluate the local inflammatory response. |
During root canal treatment, immediately after access cavity opening (single intraoperative sample).
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Incidence of Postoperative Flare-Up
Periodo de tiempo: Within 72 hours after root canal treatment.
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The occurrence of postoperative flare-up following single-visit root canal treatment will be recorded. The number and percentage of participants experiencing flare-up will be determined and compared among the six study groups. |
Within 72 hours after root canal treatment.
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Incidence of Postoperative Rescue Analgesic Intake
Periodo de tiempo: Within 72 hours after root canal treatment.
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Participants will be instructed to avoid taking analgesics unless necessary. Any postoperative rescue analgesic intake will be recorded. The number and percentage of participants requiring rescue analgesics will be compared among the six study groups. |
Within 72 hours after root canal treatment.
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Estomatognáticas
- Enfermedades de la pulpa dental
- Enfermedades de los dientes
- Pulpitis
- Compuestos de azufre
- Químicos orgánicos
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Hidrocarburos
- Hidrocarburos, cíclico
- Ácidos carboxílicos
- Hidrocarburos, aromáticos
- Amina
- Catecols
- Fenoles
- Derivados de benceno
- Alcoholes
- Amino alcoholes
- Etanolaminas
- Ácidos, carbocíclicos
- Tiofenos
- Monoaminas biogénicas
- Aminas biogénicas
- Catecolaminas
- Fenilacetatos
- Epinefrina
- Diclofenaco
- Carticaína
- dexametasona 21-fosfato
Otros números de identificación del estudio
Otros números de identificación del estudio
- 1160/2026
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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