SleeperOne® 5 Intraosseous Anesthesia in MIH (CCLAD-MIH)
Comparison of SleeperOne® 5-Assisted Intraosseous and Conventional Local Anesthesia for Pain and Anxiety Control in Children With Molar-Incisor Hypomineralization: A Randomized Split-Mouth Clinical Trial
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Molar-incisor hypomineralization (MIH) is a developmental enamel defect that frequently presents with hypersensitivity, post-eruptive enamel breakdown, and an increased risk of restorative treatment failure. Achieving effective local anesthesia in children with MIH can be challenging because hypersensitive teeth often exhibit increased pain during anesthetic administration and restorative procedures. These factors may compromise patient cooperation and the quality of dental treatment.
Computer-controlled local anesthetic delivery systems have been developed to improve injection comfort by controlling the rate and pressure of anesthetic administration. The SleeperOne® 5 system allows computer-controlled intraosseous anesthesia and may provide more effective pain control than conventional local anesthesia during restorative treatment of MIH-affected teeth.
The purpose of this study was to compare SleeperOne® 5-assisted intraosseous anesthesia with conventional local anesthesia in children undergoing restorative treatment of permanent first molars affected by MIH.
The study was conducted as a randomized split-mouth clinical trial in which each participant received both anesthetic techniques during separate treatment sessions. The order of the interventions was determined using computer-generated randomization, allowing each participant to serve as his or her own control. All clinical procedures were performed under standardized conditions by the same operator.
The study was designed to evaluate whether computer-controlled intraosseous anesthesia could improve pain control and patient comfort during restorative treatment of children with MIH compared with conventional local anesthesia.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Ankara, Turquía (Türkiye), 06560
- Ankara University Faculty of Dentistry
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Children aged 8 to 14 years.
- Bilateral symmetrical MIH-affected permanent first molars requiring restorative treatment.
- MIH diagnosed according to EAPD criteria.
- Positive or definitely positive Frankl Behavior Rating Scale.
- Parent or guardian provided written informed consent.
Exclusion Criteria:
- Acute pulpal or periapical pathology.
- Developmental dental anomalies other than MIH.
- Allergy to local anesthetic agents.
- Medical contraindication to local anesthesia.
- Analgesic or anti-inflammatory drug use within 24 hours before treatment.
- Cognitive or communication disorders affecting study assessments.
- Uncooperative behavior.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: SleeperOne® 5-Assisted Intraosseous Anesthesia
Computer-controlled intraosseous anesthesia delivered using the SleeperOne® 5 system during restorative treatment of MIH-affected permanent first molars.
|
Computer-controlled intraosseous local anesthesia delivered using the SleeperOne® 5 system during restorative treatment of MIH-affected permanent first molars.
|
|
Comparador activo: Conventional Local Anesthesia
Conventional local anesthesia administered using a standard dental syringe during restorative treatment of MIH-affected permanent first molars.
|
Conventional local anesthesia administered using a standard dental syringe during restorative treatment of MIH-affected permanent first molars.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain Perception During Anesthetic Administration
Periodo de tiempo: Immediately after completion of local anesthesia administration (T1)
|
Pain intensity during local anesthetic administration assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Higher scores indicate greater pain intensity.
|
Immediately after completion of local anesthesia administration (T1)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Behavioral Pain Response
Periodo de tiempo: Immediately after completion of local anesthesia administration and immediately after completion of the restorative treatment procedure.
|
Behavioral pain response assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale.
The FLACC Scale ranges from 0 to 10, with scores of 0 indicating no pain-related behavioral distress and scores of 10 indicating severe pain-related behavioral distress.
Higher scores indicate greater pain-related behavioral distress.
|
Immediately after completion of local anesthesia administration and immediately after completion of the restorative treatment procedure.
|
|
Dental Anxiety
Periodo de tiempo: Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.
|
Dental anxiety assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS).
The CFSS-DS score ranges from 15 to 75, with higher scores indicating greater dental anxiety.
|
Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.
|
|
Pulse Rate
Periodo de tiempo: Before local anesthesia administration (T0), immediately after local anesthesia administration (T1), and immediately after restorative treatment (T2).
|
Physiological response assessed by pulse rate (beats per minute)
|
Before local anesthesia administration (T0), immediately after local anesthesia administration (T1), and immediately after restorative treatment (T2).
|
|
Peripheral Oxygen Saturation (SpO₂)
Periodo de tiempo: Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.
|
Physiological response assessed by peripheral oxygen saturation measured by pulse oximetry as a percentage (%).
Higher values indicate greater oxygen saturation.
|
Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.
|
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 36290600/57/2023
- TDK-2024-3458 (Otro número de subvención/financiamiento: Scientific Research Projects Coordination Unit of Ankara University)
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
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .