Effectiveness of Computerized Local Anesthesia in Reducing Local Anesthesia in Reducing Child Pain During Injection (RCT)
Effectiveness of Computerized Local Anesthesia in Reducing Local Anesthesia in Reducing Child Pain During Injection (Randomized Clinical Trial)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
: the aim of this study is to evaluate star pen computerized Local Anaesthesia in reducing child pain during injection, and its impact on child behavior during extraction of primary molars.
Materials and Methods: The research will be conducted in the form of a double-blind randomized controlled clinical trial with a parallel design. A total of 40 healthy children aged 4-6 years will be selected from the Pediatric Dentistry Department, Faculty of Dentistry, Pharos University in Alexandria, Egypt. Cooperative Children with Frankl behavioral rating scale scores of 3 or 4 will be selected. Each child chosen will have at least one maxillary or mandibular primary molar that requires extraction. The guardian's written informed consent will be obtained. Participants will be assigned into two groups of 20 children each based on the dental arch where the extraction will be performed: Group I (mandibular group); and Group II (maxillary group). Each group will be further subdivided into two subgroups: test group using the star pen computerized local anesthesia, and control group using the conventional method; IANB in the mandible, and infiltration local anesthesia in the maxilla according to the method of delivery of local anaesthesia. In the present study, pain during injection will be assessed by three methods: physiologically using the heart rate, objectively using Sound, Eye, Motor (SEM) scale, and subjectively using a modified face scale from the Maunuksela scale. In each child extraction of one primary molar will be performed according to the AAPD and child behavior will be assessed using Frankl Rating Scale.
Results: To obtain the study's results and conclusions, data will be collected, tabulated, and statistically analysed using SPSS version 26.0, with a significance level set at p < 0.05.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Alexandria, Egipto
- Pharos University in Alexandria
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Completion of the written informed consent form by parents/guardian.
- Children aged between 4 and 6 years.
- Medically fit patients classified as (ASA I).
- Cooperative children with a Frankl Behaviour Rating Scale of 3 or 4.
- Patients whom their primary molars are indicated for extraction, according to criteria of extraction of (AAPD).
Exclusion Criteria:
- Children with a history of allergy to local anaesthetic agents.
- Children who receive any analgesic drugs at least 24 h before treatment.
- Any inflammation or lesion in the injection site.
- Patients who have previous bad experience of dentistry to eliminate the possible impact of the child's previous painful or stressful experiences.
- Child coming for emergency treatment of pain.
- Teeth with ankylosed roots.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Mandibular (IANB)
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CCLADS
infiltration or inferior alveolar local anesthesia
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Experimental: Maxillary Infiltration
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CCLADS
infiltration or inferior alveolar local anesthesia
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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heart rate
Periodo de tiempo: The pulse oximeter will be placed on the patient's index finger to measure the the baseline heart rate (before giving the local anesthesia by 2 minutes), another measurement will be recorded during local anesthesia administration, and during extraction.
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measuring heart rate by pulse oximeter
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The pulse oximeter will be placed on the patient's index finger to measure the the baseline heart rate (before giving the local anesthesia by 2 minutes), another measurement will be recorded during local anesthesia administration, and during extraction.
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Sound, Eye, Motor (SEM) Scale
Periodo de tiempo: will used as an objective method for pain assessment during anesthesia at end of injections immediately, after extraction immediately.
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objective method for pain assessment during LA administration scores from 1-->4 score 1=comfort(low score) score 4=severe discomfort (high score)
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will used as an objective method for pain assessment during anesthesia at end of injections immediately, after extraction immediately.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- 460 - 6/01/2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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