"Effect of Sonic Activation Assisted Irrigation and Apical Enlargement on Postoperative Endodontic Pain"
29 de abril de 2020 actualizado por: Istanbul Medipol University Hospital
The Clinical Comparative Evaluation of Sonic Activation Assisted Irrigation and Apical Enlargement on Postoperative Endodontic Pain In Retreatment: A Prospective Randomized Clinical Trial
The purpose of this randomized clinical trial is to evaluate the incidence of postoperative pain after retreatment after apical enlargement and sonic activation assisted irrigation.
The presence of postoperative pain will assess after retreatment cases at 12, 24, 48, 72 hrs and 1 week.
Descripción general del estudio
Estado
Desconocido
Condiciones
Descripción detallada
The aim of this clinical study is to evaluate the intensity and duration of postoperative pain after apical enlargement and sonic activation assisted irrigation procedures.
Patients who have asymptomatic teeth required retreatment will include in this study and retreatment procedure will be applied to these teeth.
One hundreds twenty asymptomatic teeth required retreatment will randomly participate into 4 treatment groups in terms of apical enlargement and sonic activation assisted irrigation procedure applied.
The presence of postoperative pain will assess after 12, 24, 48, 72 hrs and 1 week.
Postoperative pain will be recorded by each patient by using visual analogue pain scale.
Before the treatments, the nature of the study, complications and associated risks will be totally explained and written informed consent will be obtained from all study participants.
The local anesthetic will be applied before the treatment start.
The routine retreatment procedure will be applied.
Different final irrigation solutions will be applied in accordance to the manufacturers' instructions.
At the end of treatment, each patient will be given an evaluation sheet, explained the treatment procedure and using of visual analogue pain scales, and informed to be returned during the following one week.
After one week the teeth will be examined according to for pain intensity, percussion & palpation sensitivity, swelling, analgesic intake and clinical status.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
120
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
-Patients who were healthy volunteers and who have failed teeth required retreatment with periapical index score 3-5 score requiring root canal treatment for first time.
Patients who were not included the study who;
- were pregnant or breast feeding during the duration of the study,
- have systemic disease, have any pain and/or any facial swelling, abscess,
- were immunocompromised,
- were under 18 yrs. and over 65 yrs. age,
- were taking antibiotics or corticosteroids within previous three days,
- have multiple teeth that required root canal treatment at the same time period; for eliminating pain referral,
- have root canals that could not be well-treated with orthograde retreatment.
Exclusion Criteria:
-The patients who forgot to fill out the form and took antibiotics and/or analgesics right after the first appointment of the therapy were excluded from the study.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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: Apical enlargement
Routine retreatment procedure will be performed at working length according to the apex locator at point "0".
|
The teeth in this group will be treated according to the guidelines for retreatment in single-session.
The filling will remove and cavity will be opened.
The working length will be measured using apex locator and the "0" point will be based on.
After standard irrigation protocol, root canals will be obturated with gutta percha and root canal sealer.
Coronal restoration will complete using composite and/or fully crown if necessary.
|
|
Experimental: Apical enlargement + Sonic Activation Assisted Irrigation
Routine retreatment procedure will be performed at working length according to the apex locator at point "0" and sonic activation assisted irrigation will be applied.
|
The teeth in this group will be treated according to the guidelines for retreatment in single-session.
The filling will remove and cavity will open.
The working length will be measured using apex locator and the "0" point will be based on.
After standard irrigation protocol, sonic activation assisted irrigation will be applied to the root canals.
Then the teeth were obturated with gutta percha and root canal sealer.
Coronal restoration will complete using composite and/or fully crown if necessary.
|
|
Experimental: Non Apical enlargement
Routine retreatment procedure will be performed at working length according to the apex locator at 1mm shorter than "0" point.
|
The teeth in this group will be treated according to the guidelines for retreatment in single-session.
The filling will remove and cavity will open.
The working length will be measured using apex locator and 1 mm shorter than the "0" point will be based on.
After standard irrigation protocol, root canals will be obturated with gutta percha and root canal sealer.
Coronal restoration will complete using composite and/or fully crown if necessary.
|
|
Experimental: Non Apical enlargement + Sonic Activation Assisted Irrigation
Routine retreatment procedure will be performed at working length according to the apex locator at 1mm shorter than "0" point and sonic activation assisted irrigation will be applied.
|
The teeth in this group will be treated according to the guidelines for retreatment in single-session.
The filling will remove and cavity will open.
The working length will be measured using apex locator and 1 mm shorter than the "0" point will be based on.
After standard irrigation protocol, sonic activation assisted irrigation will be applied to the root canals.
Then the teeth were obturated with gutta percha and root canal sealer.
Coronal restoration will complete using composite and/or fully crown if necessary.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline in Postoperative Pain after Root Cana Treatment at 1 week: VAS
Periodo de tiempo: Baseline, 12, 24, 48, 72 hours and 1 week.
|
The primary outcome measure of the study is to assess if sonic activation assisted irrigation and apical enlargement procedures influence the occurrence of postoperative pain.Postoperative pain was assessed using a well defined Heft-Parker visual analogue scale (VAS) scale.
Each patient recorded the pain level on a 100-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 12, 24, 48, 72 hours and 1 week after treatment.
The VAS scale was divided into 4 categories: No pain or faint pain corresponded to 0 mm.
Mild pain was defined as greater than 0 mm and less than or equal to 25 mm.
Mild pain included the descriptors of weak and mild pain.
Moderate pain was defined as greater than 50 mm and less than 75 mm.
Intense pain was defined as equal to or greater than 75 mm.
Intense pain included the descriptors of strong, severe, and maximum possible.
|
Baseline, 12, 24, 48, 72 hours and 1 week.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
10 de junio de 2020
Finalización primaria (Anticipado)
10 de octubre de 2020
Finalización del estudio (Anticipado)
10 de diciembre de 2021
Fechas de registro del estudio
Enviado por primera vez
17 de marzo de 2020
Primero enviado que cumplió con los criterios de control de calidad
18 de marzo de 2020
Publicado por primera vez (Actual)
19 de marzo de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de mayo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
29 de abril de 2020
Última verificación
1 de marzo de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 224 (registration study)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .
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