Effect of Local Anesthesia Techniques on Pulp Hemostasis in Primary Molars
Effect of Mandibular Anesthesia and Computer-Controlled Local Anesthesia on Pulp Hemostasis Time During Pulpotomy Treatment of Mandibular Primary Molars: A Split-Mouth Study
The goal of this clinical trial is to compare the effects of two local anesthesia techniques on pulp hemostasis time during pulpotomy treatment of mandibular primary molars in children aged 6-9 years.
The main questions it aims to answer are:
Does the local anesthesia technique affect the time required to achieve pulp hemostasis during pulpotomy? Are there differences between the two anesthesia techniques in terms of pain, heart rate, and oxygen saturation during treatment?
Researchers will compare conventional inferior alveolar nerve block anesthesia with computer-controlled intraosseous local anesthesia using the QuickSleeper 5 system to determine whether the anesthesia technique affects pulp hemostasis time and the secondary clinical outcomes.
Each participant will receive both anesthesia techniques in a randomized order using a split-mouth design. Participants will:
Receive conventional inferior alveolar nerve block anesthesia for pulpotomy treatment of one mandibular primary molar.
Receive computer-controlled intraosseous local anesthesia using the QuickSleeper 5 system for pulpotomy treatment of the contralateral mandibular primary molar at a separate treatment session.
Have pulp hemostasis time recorded during each pulpotomy procedure. Have pain, heart rate, and oxygen saturation assessed during the treatment procedures.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Ayça Hande Sari
- Número de teléfono: +905065143594
- Correo electrónico: aycahande94@gmail.com
Ubicaciones de estudio
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Afyonkarahisar
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Afyonkarahisar, Afyonkarahisar, Turquía (Türkiye), 03030
- Reclutamiento
- Afyonkarahisar Health Sciences University, Faculty of Dentistry
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Contacto:
- Ayça Hande Sari
- Número de teléfono: +905065143594
- Correo electrónico: aycahande94@gmail.com
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Children aged 6-9 years.
- Presence of a pulpotomy indication in both mandibular primary second molars (teeth 75 and 85).
- Systemically healthy children classified as ASA physical status I or II.
- No known coagulation disorders.
- No use of analgesic, anti-inflammatory, antithrombotic, or antipyretic medications within the previous 7 days.
- Sufficient cooperation and compliance to allow completion of the planned clinical procedures.
- Written informed consent obtained from a parent or legal guardian for participation in the study.
- No history of a serious adverse reaction or complication associated with either of the local anesthesia techniques used in the study.
Exclusion Criteria:
- Children with systemic health conditions classified as ASA physical status III or higher.
- Known allergy or hypersensitivity to the local anesthetic agents or other dental materials used in the study.
- Presence of a known coagulation disorder or use of analgesic, anti-inflammatory, antithrombotic, or antipyretic medications within the previous 7 days.
- Presence of severe infection, pulp necrosis, advanced root resorption, or any other dental condition requiring a treatment approach other than pulpotomy in the mandibular primary second molars.
- Insufficient cooperation or behavioral difficulties that would prevent completion of the planned clinical procedures.
- History of a serious adverse reaction or complication associated with either of the local anesthesia techniques used in the study.
- Inability to comply with the study protocol or attend the scheduled study visits.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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Experimental: IANB Followed by Intraosseous Anesthesia
Participants allocated to this sequence will receive conventional inferior alveolar nerve block (IANB) anesthesia for pulpotomy treatment of one mandibular primary molar at the first treatment session.
At the second treatment session, computer-controlled intraosseous anesthesia will be administered for pulpotomy treatment of the contralateral mandibular primary molar.
The time required to achieve pulp hemostasis will be recorded during both treatment sessions.
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Conventional inferior alveolar nerve block anesthesia will be administered before pulpotomy treatment of the mandibular primary molar using a standard dental syringe and an articaine-based local anesthetic solution (Ultracain D-S Forte).
After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol.
Pulp hemostasis time will be recorded following removal of the coronal pulp tissue.
Computer-controlled intraosseous local anesthesia will be administered using the QuickSleeper 5 system (Dental Hi-Tec, France) and an articaine-based local anesthetic solution (Ultracain D-S Forte) before pulpotomy treatment of the mandibular primary molar.
After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol.
Pulp hemostasis time will be recorded following removal of the coronal pulp tissue
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Experimental: Intraosseous Anesthesia Followed by IANB
Computer-controlled intraosseous local anesthesia will be administered using the QuickSleeper 5 system (Dental Hi-Tec, France) before pulpotomy treatment of the mandibular primary molar.
After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol, and the time required to achieve pulp hemostasis will be recorded.
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Conventional inferior alveolar nerve block anesthesia will be administered before pulpotomy treatment of the mandibular primary molar using a standard dental syringe and an articaine-based local anesthetic solution (Ultracain D-S Forte).
After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol.
Pulp hemostasis time will be recorded following removal of the coronal pulp tissue.
Computer-controlled intraosseous local anesthesia will be administered using the QuickSleeper 5 system (Dental Hi-Tec, France) and an articaine-based local anesthetic solution (Ultracain D-S Forte) before pulpotomy treatment of the mandibular primary molar.
After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol.
Pulp hemostasis time will be recorded following removal of the coronal pulp tissue
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pulp Hemostasis Time
Periodo de tiempo: During pulpotomy, up to 5 minutes after coronal pulp removal
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The time required to achieve pulp hemostasis following removal of the coronal pulp tissue during pulpotomy will be recorded for each treatment session.
Hemostasis will be assessed using standardized sterile cotton pellets and categorized according to the time required to achieve bleeding control: ≤2 minutes, >2 to 5 minutes, or failure to achieve hemostasis within 5 minutes.
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During pulpotomy, up to 5 minutes after coronal pulp removal
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Peripheral Oxygen Saturation (SpO₂)
Periodo de tiempo: Immediately before local anesthesia administration
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Peripheral oxygen saturation (SpO₂) will be measured using a pulse oximeter and recorded as a percentage (%) to evaluate physiological changes associated with the anesthesia and pulpotomy procedures.
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Immediately before local anesthesia administration
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Pain Intensity
Periodo de tiempo: Immediately after local anesthesia administration and immediately after completion of the pulpotomy procedure, during each treatment visit
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Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale.
Participants will select the face that best represents their perceived pain.
The scale ranges from 0 (no pain) to 10 (worst pain), with higher scores indicating greater pain intensity.
Pain will be assessed after administration of local anesthesia and after completion of the pulpotomy procedure.
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Immediately after local anesthesia administration and immediately after completion of the pulpotomy procedure, during each treatment visit
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Heart Rate
Periodo de tiempo: Immediately before local anesthesia administration and immediately after local anesthesia administration, during each treatment visit
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Heart rate will be measured using a pulse oximeter and recorded as beats per minute (bpm) to evaluate physiological changes associated with the anesthesia and pulpotomy procedures.
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Immediately before local anesthesia administration and immediately after local anesthesia administration, during each treatment visit
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Otros números de identificación del estudio
Otros números de identificación del estudio
- 26.GENEL.013
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
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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