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Comparación de la Anestesia Intraósea Digital y la Anestesia Intraligamentaria Manual en Niños

3 de noviembre de 2026 actualizado por: Funda Cagırır Dindaroglu, Izmir Katip Celebi University

Comparación de la Anestesia Intraósea Digital y la Anestesia Intraligamentaria Manual en Niños: Un Ensayo Controlado Aleatorizado

The aim of this study is to compare the effects of digital intraosseous anesthesia and manual intraligamentary anesthesia techniques on pain scores during the restorative treatment of permanent mandibular molars in pediatric patients. In addition, the techniques will be compared in terms of injection pain, anesthetic success, postoperative complications, and patient preferences. This randomized, controlled, crossover, single-blind, split-mouth study will be conducted on 78 children aged 6-12 years. Participants with bilateral permanent mandibular molars presenting enamel-dentin carious lesions will be included in the study.

Descripción general del estudio

Descripción detallada

Participants who meet the eligibility criteria will be allocated into two study arms according to age, sex, dental experience, DMFT/dmft scores, ICDAS II classification, and radiographic findings. Each participant will receive two different anesthesia techniques-digital intraosseous anesthesia and manual intraligamentary anesthesia-applied to the right and left permanent first mandibular molars with a one-week washout period between visits.

The study population will be divided into two sequence groups. In Group 1 (n = 39), intraligamentary anesthesia will be administered during the first visit, followed by digital intraosseous anesthesia in the second visit. In Group 2 (n = 39), the sequence will be reversed, with digital intraosseous anesthesia administered first and intraligamentary anesthesia administered during the second visit.

Pain perception during both the injection phase and the restorative procedure will be subjectively assessed using the Visual Analog Scale (VAS) and the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including heart rate and arterial oxygen saturation, will be monitored and recorded. Anesthetic quality and success will be evaluated at the end of each visit based on the clinical outcomes of the restorative procedure.

Following each anesthesia administration, participants will be informed of potential complications, including allergic reactions, a sensation of tooth elevation, or postoperative sensitivity related to the restoration. They will be instructed to document any complications encountered. Postoperative complications will be collected by contacting participants one day after both the first and second visits. At the end of the second visit, each participant's preferred anesthesia technique will also be recorded.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

78

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.

Estudio Contacto

  • Nombre: Funda Çağırır Dindaroğlu, Study Director
  • Número de teléfono: +905363465653
  • Correo electrónico: fundacagirir@gmail.com

Copia de seguridad de contactos de estudio

  • Nombre: Buse Düzgün, Principal Investigator
  • Número de teléfono: +905073022366
  • Correo electrónico: busedzgn@hotmail.com

Ubicaciones de estudio

    • Cigli
      • Izmir, Cigli, Turquía (Türkiye), 35000
        • Reclutamiento
        • Izmir Katip Çelebi University Faculty of Dentistry
        • Contacto:

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

6 años a 12 años (Niño)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Subjects with American Society of Anesthesiologists score I (ASA I)
  • Subjects with Frankl's behavior rate III (positive) and IV (definitely positive),
  • Subjects with indication of similar restoration treatment on bilateral first -permanent mandibular molars
  • Subjects whose plaque index score of 0 (no plaque) and 1
  • Subjects whose gingival index score of 0

Exclusion Criteria:

  • Allergic to the local anesthetics or sulfites
  • Subjects with cholinesterase deficiency
  • Subjects who use drugs that may affect the assessment of pain, such as narcotic or non-narcotic analgesic, anti-inflammatory, anxiolytic, antipsychotic and antihistamine agents
  • Subjects who need to use sedatives or other medications during dental procedures

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 cruzada
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Intraligamentary Anaesthesia

Before the restorative treatment of mandibular first molar, SOPIRA® 30 gauge extra-short cartridge needle attached to the tip of the SOPIRA® Citoject (SOPIRA® Heraeus Kulzer, Hanau, Almanya) pressure injector will be inserted into the periodontal sulcus 1-2 mm until resistance. The needle will be at an angle of 30 degrees to the long axis of the tooth. As recommended by the manufacturer, a total of 0.36 ml (mesiobuccal and distobuccal) 4% articaine solution containing 1:100,000 epinephrine (Ultracaine DS forte cartridge, Sanofi-Aventis GmbH, Almanya) will be injected slowly over 42 seconds by pressing the dosing lever 3 times for each root. If the anaesthesia will be failed, we would use the 4-point IL injection by injecting the mesiolingual sulcus and distolingual sulcus with the same technique.

Anesthesia One tooth anaesthesia by 2 or 4 points intraligamentary injection

Otros nombres:
  • Inyección intraligamentaria de 2 o 4 puntos
Comparador activo: Digital Intraosseous Anesthesia

For the digital intraosseous anesthesia technique, the handpiece will be stabilized by holding it as close to the needle as possible and maintaining firm support on the device holder to ensure maximum precision. To enhance the accuracy of movements, stable intraoral finger rests will be used throughout the procedure. The Effitec needle will be positioned at the papillary apex and oriented toward the area between the apices of the two adjacent teeth.

To maintain correct needle positioning and prevent rotational movement, the handpiece will be held nearly parallel to the gingival tissues. Penetration will be directed toward the center of the interdental septum. When the needle enters the cancellous bone, a characteristic sensation similar to cracking an eggshell may be perceived. Before initiating the injection, the needle will be slightly withdrawn to ensure proper placement and avoid excessive penetration.

Anesthesia for one tooth using computer-controlled single-point injection into cancellous bone

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pain intensity using Visual Analog Scale (VAS)
Periodo de tiempo: During injection and during dental procedure

Subjective pain perception measured using a 0-10 Visual Analog Scale (0 = no pain, 10 = worst possible pain). Pain is assessed during injection and during dental treatment.

During injection and during dental procedure
Pain intensity using Wong-Baker FACES Pain Rating Scale
Periodo de tiempo: During injection and during dental procedure

Subjective pain perception measured using the Wong-Baker FACES Pain Rating Scale (0-10), where higher scores indicate greater pain. Pain is assessed during injection and during dental treatment.

During injection and during dental procedure
Heart rate changes
Periodo de tiempo: Baseline, during injection and during dental procedure

Heart rate measured using a pulse oximeter (beats per minute, bpm).

Baseline, during injection and during dental procedure
Oxygen saturation (SpO₂) changes
Periodo de tiempo: Baseline, during injection and during dental procedure

Arterial oxygen saturation measured using a pulse oximeter (%).

Baseline, during injection and during dental procedure
Practitioner's assessment of anesthesia success
Periodo de tiempo: Immediately after dental treatment

Clinician-reported outcomes including need for additional anesthesia, presence of discomfort during treatment, and successful completion of the procedure without pain.

Immediately after dental treatment
Postoperative complications
Periodo de tiempo: Day 1 after intervention

Presence of postoperative complications related to local anesthesia.

Day 1 after intervention

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Correlation between pain scores measured by VAS and Wong-Baker FACES scale
Periodo de tiempo: Immediately after injection

Correlation between pain scores measured using the Visual Analog Scale (VAS, 0-10) and Wong-Baker FACES Pain Rating Scale (0-10) following local anesthetic injection in children aged 6-12 years. Higher scores indicate greater pain intensity.

Immediately after injection

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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 (Actual)

1 de abril de 2026

Finalización primaria (Estimado)

1 de octubre de 2027

Finalización del estudio (Estimado)

1 de octubre de 2027

Fechas de registro del estudio

Enviado por primera vez

24 de marzo de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de abril de 2026

Publicado por primera vez (Actual)

13 de abril de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2025/75

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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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